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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-000188-33 | EudraCT Number | ||
| MK-8616-146 | Other Identifier | Merck Protocol Number |
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The purpose of this trial is to evaluate the safety and efficacy of Sugammadex when administered according to actual body weight (ABW) as compared to ideal body weight (IBW) for the reversal of both moderate and deep neuromuscular blockade (NMB) induced by either Rocuronium or Vecuronium in morbidly obese participants. The primary hypothesis of this investigation is that, compared to obese participants dosed based on IBW, obese participants receiving Sugammadex according to ABW will demonstrate a faster time to recovery to a Train Of Four (TOF) ratio of ≥0.9 (i.e. faster NMB reversal), pooled across NMB depth and type of neuromuscular blocking agent (NMBA; Rocuronium or Vecuronium) administered.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sugammadex 2 mg/kg ABW | Experimental | Following administration of NMBA, participants received a single intravenous (i.v.) bolus of Sugammadex at 2 mg/kg as determined utilizing participant ABW. A treatment dose of 2 mg/kg was used for reversal of moderate NMB. |
|
| Sugammadex 2 mg/kg IBW | Experimental | Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant IBW. A treatment dose of 2 mg/kg was used for reversal of moderate NMB. |
|
| Sugammadex 4 mg/kg ABW | Experimental | Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant ABW. A treatment dose of 4 mg/kg was used for reversal of deep NMB. |
|
| Sugammadex 4 mg/kg IBW | Experimental | Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant IBW. A treatment dose of 4 mg/kg was used for reversal of deep NMB. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sugammadex 2 mg/kg ABW | Drug | Following administration of NMBA (Rocuronium or Vecuronium) to achieve moderate NMB, participants received a single i.v. bolus of Sugammadex (2 mg/kg by ABW) for reversal of moderate NMB. Moderate NMB is defined as the reappearance of a second twitch (T2) in response to TOF stimulations. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Recovery (TTR) of Participant Train Of Four (TOF) Ratio to ≥0.9: Primary Kaplan-Meier Analysis | The primary efficacy analysis of TTR of TOF ratio to ≥0.9 was performed by estimating event rates within each treatment group using the Kaplan-Meier method. TTR was monitored by applying electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to magnitudes of the first and fourth twitches respectively, after nerve stimulation. The T4/T1 ratio (TOF; expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster TTR of the TOF ratio to 0.9 indicates faster recovery from NMB. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW). | Up to 76 minutes |
| Percentage of Participants With Treatment-Emergent Sinus Bradycardia Events | The percentage of participants experiencing treatment-emergent bradycardia events were identified with continuous electrocardiogram (ECG) monitoring. Treatment-emergent sinus bradycardia is defined as a heart rate <60 bpm that has also decreased more than 20% compared to participant baseline heart rate value, sustained for at least 1 minute after administration of study intervention. Treatment-emergent sinus bradycardia events may or may not be considered an adverse event (AE), as determined by investigator judgment. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW). | Up to 35 minutes |
| Percentage of Participants With Treatment-Emergent Sinus Tachycardia Events | The percentage of participants experiencing treatment-emergent sinus tachycardia events were identified with continuous ECG monitoring. Treatment-emergent sinus tachycardia is defined as a heart rate ≥100 bpm that has also increased more than 20% compared to participant baseline heart rate value, sustained for at least 1 minute after administration of study intervention. Treatment-emergent sinus tachycardia events may or may not be considered an AE, as determined by investigator judgment. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Prolonged (>10 Minutes) Time to Recovery (TTR) of the Train Of Four (TOF) Ratio to ≥0.9 | Following administration of study intervention, the percentage of participants experiencing prolonged (>10 minutes) recovery to a TOF ratio ≥0.9 was calculated. TTR was monitored by applying electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to magnitudes of the first and fourth twitches respectively, after nerve stimulation. The T4/T1 ratio (TOF; expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster TTR of the TOF ratio to 0.9 indicates faster recovery from NMB. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University California / Davis ( Site 2001) | Sacramento | California | 95817 | United States | ||
| Jackson Memorial Hospital/University of Miami ( Site 2007) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33278332 | Background | Mostoller K, Wrishko R, Maganti L, Herring WJ, van Zutphen-van Geffen M. Pharmacokinetics of Sugammadex Dosed by Actual and Ideal Body Weight in Patients With Morbid Obesity Undergoing Surgery. Clin Transl Sci. 2021 Mar;14(2):737-744. doi: 10.1111/cts.12941. Epub 2020 Dec 16. | |
| 33639839 | Derived | Horrow JC, Li W, Blobner M, Lombard J, Speek M, DeAngelis M, Herring WJ. Actual versus ideal body weight dosing of sugammadex in morbidly obese patients offers faster reversal of rocuronium- or vecuronium-induced deep or moderate neuromuscular block: a randomized clinical trial. BMC Anesthesiol. 2021 Feb 27;21(1):62. doi: 10.1186/s12871-021-01278-w. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sugammadex 2 mg/kg Actual Body Weight (ABW) | Following administration of NMBA, participants received a single intravenous (i.v.) bolus of Sugammadex at 2 mg/kg as determined utilizing participant ABW. A treatment dose of 2 mg/kg was used for reversal of moderate NMB. |
| FG001 | Sugammadex 4 mg/kg ABW |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 5, 2018 | Dec 4, 2019 |
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| Neostigmine/Glycopyrrolate |
| Active Comparator |
Following administration of NMBA, participants received a single i.v. bolus containing both Neostigmine (50 µg/kg; up to 5 mg maximum dose) and Glycopyrrolate (10 µg/kg; up to 1 mg maximum dose) as determined utilizing participant ABW. Neostigmine/Glycopyrrolate was used for reversal of moderate NMB. Active comparator treatment for reversal for deep NMB was not available. |
|
|
|
| Sugammadex 2 mg/kg IBW | Drug | Following administration of NMBA (Rocuronium or Vecuronium) to achieve moderate NMB, participants received a single i.v. bolus of Sugammadex (2 mg/kg by IBW) for reversal of moderate NMB. Moderate NMB is defined as the reappearance of T2 in response to TOF stimulations. |
|
|
| Sugammadex 4 mg/kg ABW | Drug | Following administration of NMBA (Rocuronium or Vecuronium) to achieve deep NMB, participants received a single i.v. bolus of Sugammadex (4 mg/kg by ABW) for reversal of deep NMB. Deep NMB is defined as no response to TOF stimulations (TOF=0) and a detection target of 1-2 post-tetanic counts (PTCs). |
|
|
| Sugammadex 4 mg/kg IBW | Drug | Following administration of NMBA (Rocuronium or Vecuronium) to achieve deep NMB, participants will receive a single i.v. bolus of Sugammadex (4 mg/kg by IBW) for reversal of deep NMB. Deep NMB is defined as no response to TOF stimulations (TOF=0) and a detection target of 1-2 post-tetanic counts (PTCs). |
|
|
| Neostigmine + Glycopyrrolate | Drug | Following administration of NMBA (Rocuronium or Vecuronium) to achieve moderate NMB, participants received a single i.v. bolus of Neostigmine (50 µg/kg; 5 mg maximum) and Glycopyrrolate (10 µg/kg; 1 mg maximum), dosed according to participant ABW for reversal of moderate NMB. Moderate NMB is defined as the reappearance of T2 in response to TOF stimulations. |
|
| Rocuronium or Vecuronium | Drug | To achieve NMB, participants received steroidal NMBA Rocuronium Bromide or Vecuronium Bromide administered via i.v. infusion and dosed according to participant ABW. NMBAs were concomitant medications used per label as adjunct to general anesthesia. |
|
| Up to 35 minutes |
| Percentage of Participants With Other Treatment-Emergent Cardiac Arrhythmia Events | The percentage of participants experiencing other treatment-emergent cardiac arrhythmia events were identified with continuous ECG monitoring. Other treatment-emergent cardiac arrhythmias are defined as new or worsening arrhythmias (e.g., atrial fibrillation, atrial tachyarrhythmia, ventricular fibrillation, or ventricular tachyarrhythmia), sustained for at least 1 minute after administration of study intervention. Worsening arrhythmia events may or may not be considered an AE, as determined by investigator judgment. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW). | Up to 35 minutes |
| Percentage of Participants Experiencing an Adverse Event (AE) After Administration of Study Intervention | The percentage of participants experiencing an AE following administration of study intervention was monitored. An AE is any unfavorable and unintended medical occurrence, symptom, or disease witnessed in a participant, regardless of whether or not a causal relationship with the study treatment can be demonstrated. Further, any worsening (i.e. any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study treatment is also considered an AE. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW). | Up to 7 days |
| Percentage of Participants Experiencing a Serious Adverse Event (SAE) After Administration of Study Intervention | The percentage of participants experiencing an SAE following administration of study intervention was monitored. An SAE is an adverse event that: results in death; is life threatening; results in persistent or significant disability or incapacity; results in or prolongs a hospitalization; is a congenital anomaly or birth defect; is a cancer; or may jeopardize the participant, potentially requiring medical or surgical intervention. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW). | Up to 7 days |
| Percentage of Participants Experiencing an Event of Clinical Interest (ECI) After Administration of Study Intervention | The percentage of participants experiencing an ECI following administration of study intervention was monitored. ECIs are a discrete set of both AEs and SAEs, specifically designated as such for the trial. For the purposes of this investigation, ECIs included 1) drug-induced liver injury; 2) clinically-relevant arrhythmias, inclusive of bradycardia and tachycardia defined as events necessitating intervention, as determined by investigator judgment; and 3) instances of hypersensitivity and/or anaphylaxis adjudicated by an external expert Adjudication Committee. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW). | Up to 7 days |
| Up to 76 minutes |
| Time to Recovery (TTR) of Participant Train of Four (TOF) Ratio to ≥0.9: Secondary Geometric Mean Analysis | The secondary efficacy analysis of TTR of participant TOF ratio to ≥0.9 was performed by estimating the geometric mean of TTR within each treatment group. TTR was monitored by applying electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to magnitudes of the first and fourth twitches respectively, after nerve stimulation. The T4/T1 ratio (TOF; expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster TTR of the TOF ratio to 0.9 indicates faster recovery from NMB. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW). | Up to 76 minutes |
| Time to Recovery (TTR) of Participant Train of Four (TOF) Ratio to ≥0.8: Geometric Mean Analysis | The efficacy analysis of TTR of participant TOF ratio to ≥0.8 was performed by estimating the geometric mean of TTR within each treatment group. TTR was monitored by applying electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to magnitudes of the first and fourth twitches respectively, after nerve stimulation. The T4/T1 ratio (TOF; expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster TTR of the TOF ratio to 0.8 indicates faster recovery from NMB. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW). | Up to 69 minutes |
| Time to Recovery (TTR) of Participant Train of Four (TOF) Ratio to ≥0.7: Geometric Mean Analysis | The efficacy analysis of TTR of participant TOF ratio to ≥0.7 was performed by estimating the geometric mean of TTR within each treatment group. TTR was monitored by applying electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to magnitudes of the first and fourth twitches respectively, after nerve stimulation. The T4/T1 ratio (TOF; expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster TTR of the TOF ratio to 0.7 indicates faster recovery from NMB. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW). | Up to 61 minutes |
| Miami |
| Florida |
| 33136 |
| United States |
| University of Kansas Medical Center ( Site 2049) | Kansas City | Kansas | 66160 | United States |
| William Beaumont Hospital - Royal Oak ( Site 2033) | Royal Oak | Michigan | 48073 | United States |
| University Hospital- Columbia MO ( Site 2060) | Columbia | Missouri | 65212 | United States |
| Robert Wood Johnson University Hospital ( Site 2037) | New Brunswick | New Jersey | 08901 | United States |
| Mission Hospital - St. Joseph ( Site 2015) | Asheville | North Carolina | 28801 | United States |
| Cleveland Clinic Foundation ( Site 2031) | Cleveland | Ohio | 44195 | United States |
| Temple University Hospital ( Site 2004) | Philadelphia | Pennsylvania | 19140 | United States |
| Vanderbilt University Medical Center ( Site 2032) | Nashville | Tennessee | 37232 | United States |
| Hermann Drive Surgical Center ( Site 2020) | Houston | Texas | 77004 | United States |
| Hermann Drive Surgical Center ( Site 2059) | Houston | Texas | 77004 | United States |
| Zablocki VA Medical Center ( Site 2011) | Milwaukee | Wisconsin | 53295 | United States |
| Sozialmedizinisches Zentrum Ost - Donauspital ( Site 2150) | Vienna | 1220 | Austria |
| Universitaire Ziekenhuis Antwerpen - UZA ( Site 2200) | Edegem | 2650 | Belgium |
| Rigshospitalet ( Site 2253) | Copenhagen | 2100 | Denmark |
| Bispebjerg og Frederiksberg Hospital ( Site 2250) | Copenhagen NV | 2400 | Denmark |
| Johanniter Krankenhaus Bonn ( Site 2353) | Bonn | 53113 | Germany |
| Diakovere Annastift gGmbH ( Site 2355) | Hanover | 30625 | Germany |
| Universitatsklinikum Giessen und Marburg GmbH ( Site 2356) | Marburg | 35043 | Germany |
| Klinikum Rechts der Isar Technische Universitaet Muenchen ( Site 2350) | München | 81675 | Germany |
| St. Franziskus-Hospital ( Site 2354) | Münster | 48145 | Germany |
| Klinikum am Steinenberg Reutlingen ( Site 2352) | Reutlingen | 72764 | Germany |
| Josephs-Hospitals Warendorf ( Site 2351) | Warendorf | 48231 | Germany |
Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant ABW. A treatment dose of 4 mg/kg was used for reversal of deep NMB. |
| FG002 | Sugammadex 2 mg/kg Ideal Body Weight (IBW) | Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant IBW. A treatment dose of 2 mg/kg was used for reversal of moderate NMB. |
| FG003 | Sugammadex 4 mg/kg IBW | Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant IBW. A treatment dose of 4 mg/kg was used for reversal of deep NMB. |
| FG004 | Neostigmine/Glycopyrrolate | Following administration of NMBA, participants received a single i.v. bolus containing both Neostigmine (50 µg/kg; up to 5 mg maximum dose) and Glycopyrrolate (10 µg/kg; up to 1 mg maximum dose) as determined utilizing participant ABW. Neostigmine/Glycopyrrolate was used for reversal of moderate NMB. Active comparator treatment for reversal for deep NMB was not available. |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sugammadex 2 mg/kg ABW | Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant ABW. A treatment dose of 2 mg/kg was used for reversal of moderate NMB. |
| BG001 | Sugammadex 4 mg/kg ABW | Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant ABW. A treatment dose of 4 mg/kg was used for reversal of deep NMB. |
| BG002 | Sugammadex 2 mg/kg IBW | Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant IBW. A treatment dose of 2 mg/kg was used for reversal of moderate NMB. |
| BG003 | Sugammadex 4 mg/kg IBW | Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant IBW. A treatment dose of 4 mg/kg was used for reversal of deep NMB. |
| BG004 | Neostigmine/Glycopyrrolate | Following administration of NMBA, participants received a single i.v. bolus containing both Neostigmine (50 µg/kg; up to 5 mg maximum dose) and Glycopyrrolate (10 µg/kg; up to 1 mg maximum dose) as determined utilizing participant ABW. Neostigmine/Glycopyrrolate was used for reversal of moderate NMB. Active comparator treatment for reversal for deep NMB was not available. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Recovery (TTR) of Participant Train Of Four (TOF) Ratio to ≥0.9: Primary Kaplan-Meier Analysis | The primary efficacy analysis of TTR of TOF ratio to ≥0.9 was performed by estimating event rates within each treatment group using the Kaplan-Meier method. TTR was monitored by applying electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to magnitudes of the first and fourth twitches respectively, after nerve stimulation. The T4/T1 ratio (TOF; expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster TTR of the TOF ratio to 0.9 indicates faster recovery from NMB. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW). | All randomized participants dosed with both an NMBA and an NMB reversal agent (study treatment) with ≥1 post-randomization efficacy assessment. As specified by the protocol, analysis was performed in treatment arms pooled by dosing method across depth of NMB as well as in all randomized treatment arms separated by depth of NMB. | Posted | Median | 95% Confidence Interval | Minutes | Up to 76 minutes |
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| Primary | Percentage of Participants With Treatment-Emergent Sinus Bradycardia Events | The percentage of participants experiencing treatment-emergent bradycardia events were identified with continuous electrocardiogram (ECG) monitoring. Treatment-emergent sinus bradycardia is defined as a heart rate <60 bpm that has also decreased more than 20% compared to participant baseline heart rate value, sustained for at least 1 minute after administration of study intervention. Treatment-emergent sinus bradycardia events may or may not be considered an adverse event (AE), as determined by investigator judgment. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW). | All randomized participants who received at least one dose of study treatment. As specified by the protocol, analysis was performed in treatment arms pooled by dosing method across depth of NMB as well as in all randomized treatment arms separated by depth of NMB. | Posted | Number | Percentage of participants | Up to 35 minutes |
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| Primary | Percentage of Participants With Treatment-Emergent Sinus Tachycardia Events | The percentage of participants experiencing treatment-emergent sinus tachycardia events were identified with continuous ECG monitoring. Treatment-emergent sinus tachycardia is defined as a heart rate ≥100 bpm that has also increased more than 20% compared to participant baseline heart rate value, sustained for at least 1 minute after administration of study intervention. Treatment-emergent sinus tachycardia events may or may not be considered an AE, as determined by investigator judgment. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW). | All randomized participants who received at least one dose of study treatment. As specified by the protocol, analysis was performed in treatment arms pooled by dosing method across depth of NMB as well as in all randomized treatment arms separated by depth of NMB. | Posted | Number | Percentage of participants | Up to 35 minutes |
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| Primary | Percentage of Participants With Other Treatment-Emergent Cardiac Arrhythmia Events | The percentage of participants experiencing other treatment-emergent cardiac arrhythmia events were identified with continuous ECG monitoring. Other treatment-emergent cardiac arrhythmias are defined as new or worsening arrhythmias (e.g., atrial fibrillation, atrial tachyarrhythmia, ventricular fibrillation, or ventricular tachyarrhythmia), sustained for at least 1 minute after administration of study intervention. Worsening arrhythmia events may or may not be considered an AE, as determined by investigator judgment. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW). | All randomized participants who received at least one dose of study treatment. As specified by the protocol, analysis was performed in treatment arms pooled by dosing method across depth of NMB as well as in all randomized treatment arms separated by depth of NMB. | Posted | Number | Percentage of participants | Up to 35 minutes |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Experiencing an Adverse Event (AE) After Administration of Study Intervention | The percentage of participants experiencing an AE following administration of study intervention was monitored. An AE is any unfavorable and unintended medical occurrence, symptom, or disease witnessed in a participant, regardless of whether or not a causal relationship with the study treatment can be demonstrated. Further, any worsening (i.e. any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study treatment is also considered an AE. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW). | All randomized participants who received at least one dose of study treatment. As specified by the protocol, analysis was performed in treatment arms pooled by dosing method across depth of NMB as well as in all randomized treatment arms separated by depth of NMB. | Posted | Number | Percentage of participants | Up to 7 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Experiencing a Serious Adverse Event (SAE) After Administration of Study Intervention | The percentage of participants experiencing an SAE following administration of study intervention was monitored. An SAE is an adverse event that: results in death; is life threatening; results in persistent or significant disability or incapacity; results in or prolongs a hospitalization; is a congenital anomaly or birth defect; is a cancer; or may jeopardize the participant, potentially requiring medical or surgical intervention. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW). | All randomized participants who received at least one dose of study treatment. As specified by the protocol, analysis was performed in treatment arms pooled by dosing method across depth of NMB as well as in all randomized treatment arms separated by depth of NMB. | Posted | Number | Percentage of participants | Up to 7 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Experiencing an Event of Clinical Interest (ECI) After Administration of Study Intervention | The percentage of participants experiencing an ECI following administration of study intervention was monitored. ECIs are a discrete set of both AEs and SAEs, specifically designated as such for the trial. For the purposes of this investigation, ECIs included 1) drug-induced liver injury; 2) clinically-relevant arrhythmias, inclusive of bradycardia and tachycardia defined as events necessitating intervention, as determined by investigator judgment; and 3) instances of hypersensitivity and/or anaphylaxis adjudicated by an external expert Adjudication Committee. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW). | All randomized participants who received at least one dose of study treatment. As specified by the protocol, analysis was performed in treatment arms pooled by dosing method across depth of NMB as well as in all randomized treatment arms separated by depth of NMB. | Posted | Number | Percentage of participants | Up to 7 days |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Prolonged (>10 Minutes) Time to Recovery (TTR) of the Train Of Four (TOF) Ratio to ≥0.9 | Following administration of study intervention, the percentage of participants experiencing prolonged (>10 minutes) recovery to a TOF ratio ≥0.9 was calculated. TTR was monitored by applying electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to magnitudes of the first and fourth twitches respectively, after nerve stimulation. The T4/T1 ratio (TOF; expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster TTR of the TOF ratio to 0.9 indicates faster recovery from NMB. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW). | All randomized participants dosed with both an NMBA and an NMB reversal agent (study treatment) with ≥1 post-randomization efficacy assessment. As specified by the protocol, analysis was performed in treatment arms pooled by dosing method across depth of NMB as well as in all randomized treatment arms separated by depth of NMB. | Posted | Number | Percentage of participants | Up to 76 minutes |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Recovery (TTR) of Participant Train of Four (TOF) Ratio to ≥0.9: Secondary Geometric Mean Analysis | The secondary efficacy analysis of TTR of participant TOF ratio to ≥0.9 was performed by estimating the geometric mean of TTR within each treatment group. TTR was monitored by applying electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to magnitudes of the first and fourth twitches respectively, after nerve stimulation. The T4/T1 ratio (TOF; expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster TTR of the TOF ratio to 0.9 indicates faster recovery from NMB. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW). | All randomized participants dosed with both an NMBA and an NMB reversal agent (study treatment) with ≥1 post-randomization efficacy assessment. As specified by the protocol, analysis was performed in treatment arms pooled by dosing method across depth of NMB as well as in all randomized treatment arms separated by depth of NMB. | Posted | Geometric Mean | 95% Confidence Interval | Minutes | Up to 76 minutes |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Recovery (TTR) of Participant Train of Four (TOF) Ratio to ≥0.8: Geometric Mean Analysis | The efficacy analysis of TTR of participant TOF ratio to ≥0.8 was performed by estimating the geometric mean of TTR within each treatment group. TTR was monitored by applying electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to magnitudes of the first and fourth twitches respectively, after nerve stimulation. The T4/T1 ratio (TOF; expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster TTR of the TOF ratio to 0.8 indicates faster recovery from NMB. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW). | All randomized participants dosed with both an NMBA and an NMB reversal agent (study treatment) with ≥1 post-randomization efficacy assessment. As specified by the protocol, analysis was performed in treatment arms pooled by dosing method across depth of NMB as well as in all randomized treatment arms separated by depth of NMB. | Posted | Geometric Mean | 95% Confidence Interval | Minutes | Up to 69 minutes |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Recovery (TTR) of Participant Train of Four (TOF) Ratio to ≥0.7: Geometric Mean Analysis | The efficacy analysis of TTR of participant TOF ratio to ≥0.7 was performed by estimating the geometric mean of TTR within each treatment group. TTR was monitored by applying electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to magnitudes of the first and fourth twitches respectively, after nerve stimulation. The T4/T1 ratio (TOF; expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB. A faster TTR of the TOF ratio to 0.7 indicates faster recovery from NMB. As specified by the protocol, analyses for this outcome measure were conducted in participants pooled by dosing method across depth of NMB (Sugammadex ABW [2 mg/kg ABW plus 4 mg/kg ABW] and Sugammadex IBW [2 mg/kg IBW plus 4 mg/kg IBW]) as well as in all randomized treatment arms separated by depth of NMB (Sugammadex 2 mg/kg ABW, Sugammadex 4 mg/kg ABW, Sugammadex 2 mg/kg IBW, and Sugammadex 4 mg/kg IBW). | All randomized participants dosed with both an NMBA and an NMB reversal agent (study treatment) with ≥1 post-randomization efficacy assessment. As specified by the protocol, analysis was performed in treatment arms pooled by dosing method across depth of NMB as well as in all randomized treatment arms separated by depth of NMB. | Posted | Geometric Mean | 95% Confidence Interval | Minutes | Up to 61 minutes |
|
Up to 14 days
Analysis population consisted of all randomized participants who received at least one dose of study treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sugammadex 2 mg/kg ABW | Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant ABW. A treatment dose of 2 mg/kg was used for reversal of moderate NMB. | 0 | 38 | 1 | 38 | 36 | 38 |
| EG001 | Sugammadex 4 mg/kg ABW | Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant ABW. A treatment dose of 4 mg/kg was used for reversal of deep NMB. | 0 | 38 | 0 | 38 | 32 | 38 |
| EG002 | Sugammadex 2 mg/kg IBW | Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant IBW. A treatment dose of 2 mg/kg was used for reversal of moderate NMB. | 0 | 38 | 3 | 38 | 36 | 38 |
| EG003 | Sugammadex 4 mg/kg IBW | Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant IBW. A treatment dose of 4 mg/kg was used for reversal of deep NMB. | 0 | 36 | 4 | 36 | 32 | 36 |
| EG004 | Neostigmine + Glycopyrrolate | Following administration of NMBA, participants received a single i.v. bolus containing both Neostigmine (50 µg/kg; up to 5 mg maximum dose) and Glycopyrrolate (10 µg/kg; up to 1 mg maximum dose) as determined utilizing participant ABW. Neostigmine/Glycopyrrolate was used for reversal of moderate NMB. Active comparator treatment for reversal for deep NMB was not available. | 1 | 38 | 3 | 38 | 32 | 38 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiovascular insufficiency | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Tachyarrhythmia | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Impaired healing | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Postoperative wound complication | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Borderline ovarian tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Cardiovascular disorder | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Short-bowel syndrome | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Anaemia postoperative | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Incision site pain | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Neuromuscular block prolonged | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Procedural nausea | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Procedural vomiting | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Heart rate increased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Oxygen saturation decreased | Investigations | MedDRA 21.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
|
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 20, 2019 | Dec 4, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000077122 | Sugammadex |
| D009388 | Neostigmine |
| D006024 | Glycopyrrolate |
| D000077123 | Rocuronium |
| D014673 | Vecuronium Bromide |
| ID | Term |
|---|---|
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D003912 | Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D050338 | Phenylammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009861 | Onium Compounds |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000732 | Androstanols |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Following administration of NMBA, participants who received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant IBW, and those who received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant IBW were pooled by dosing method across depth of NMB. Treatment doses of 2 mg/kg and 4 mg/kg were used for reversal of moderate NMB and deep NMB respectively.
| OG006 | Neostigmine/Glycopyrrolate | Following administration of NMBA, participants received a single i.v. bolus containing both Neostigmine (50 µg/kg; up to 5 mg maximum dose) and Glycopyrrolate (10 µg/kg; up to 1 mg maximum dose) as determined utilizing participant ABW. Neostigmine/Glycopyrrolate was used for reversal of moderate NMB. Active comparator treatment for reversal for deep NMB was not available. |
| Hazard Ratio (HR) |
| 25.90 |
| 2-Sided |
| 95 |
| 9.72 |
| 69.03 |
Cox regression model |
| Superiority |
| Log Rank | <0.0001 | Hazard Ratio (HR) | 61.40 | 2-Sided | 95 | 14.13 | 266.77 | Cox regression model | Superiority |
| Log Rank | 0.0005 | Hazard Ratio (HR) | 2.38 | 2-Sided | 95 | 1.44 | 3.93 | Cox regression model | Superiority |
| Log Rank | <0.0001 | Hazard Ratio (HR) | 2.13 | 2-Sided | 95 | 1.50 | 3.01 | Cox regression model | Superiority |
| Sugammadex 4 mg/kg ABW |
Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant ABW. A treatment dose of 4 mg/kg was used for reversal of deep NMB. |
| OG002 | Sugammadex ABW (2 mg/kg ABW Plus 4 mg/kg ABW) | Following administration of NMBA, participants who received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant ABW, and those who received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant ABW were pooled by dosing method across depth of NMB. Treatment doses of 2 mg/kg and 4 mg/kg were used for reversal of moderate NMB and deep NMB respectively. |
| OG003 | Sugammadex 2 mg/kg IBW | Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant IBW. A treatment dose of 2 mg/kg was used for reversal of moderate NMB. |
| OG004 | Sugammadex 4 mg/kg IBW | Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant IBW. A treatment dose of 4 mg/kg was used for reversal of deep NMB. |
| OG005 | Sugammadex IBW (2 mg/kg IBW Plus 4 mg/kg IBW) | Following administration of NMBA, participants who received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant IBW, and those who received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant IBW were pooled by dosing method across depth of NMB. Treatment doses of 2 mg/kg and 4 mg/kg were used for reversal of moderate NMB and deep NMB respectively. |
| OG006 | Neostigmine/Glycopyrrolate | Following administration of NMBA, participants received a single i.v. bolus containing both Neostigmine (50 µg/kg; up to 5 mg maximum dose) and Glycopyrrolate (10 µg/kg; up to 1 mg maximum dose) as determined utilizing participant ABW. Neostigmine/Glycopyrrolate was used for reversal of moderate NMB. Active comparator treatment for reversal for deep NMB was not available. |
|
|
|
| Sugammadex 4 mg/kg ABW |
Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant ABW. A treatment dose of 4 mg/kg was used for reversal of deep NMB. |
| OG002 | Sugammadex ABW (2 mg/kg ABW Plus 4 mg/kg ABW) | Following administration of NMBA, participants who received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant ABW, and those who received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant ABW were pooled by dosing method across depth of NMB. Treatment doses of 2 mg/kg and 4 mg/kg were used for reversal of moderate NMB and deep NMB respectively. |
| OG003 | Sugammadex 2 mg/kg IBW | Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant IBW. A treatment dose of 2 mg/kg was used for reversal of moderate NMB. |
| OG004 | Sugammadex 4 mg/kg IBW | Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant IBW. A treatment dose of 4 mg/kg was used for reversal of deep NMB. |
| OG005 | Sugammadex IBW (2 mg/kg IBW Plus 4 mg/kg IBW) | Following administration of NMBA, participants who received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant IBW, and those who received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant IBW were pooled by dosing method across depth of NMB. Treatment doses of 2 mg/kg and 4 mg/kg were used for reversal of moderate NMB and deep NMB respectively. |
| OG006 | Neostigmine/Glycopyrrolate | Following administration of NMBA, participants received a single i.v. bolus containing both Neostigmine (50 µg/kg; up to 5 mg maximum dose) and Glycopyrrolate (10 µg/kg; up to 1 mg maximum dose) as determined utilizing participant ABW. Neostigmine/Glycopyrrolate was used for reversal of moderate NMB. Active comparator treatment for reversal for deep NMB was not available. |
|
|
|
| Sugammadex 4 mg/kg ABW |
Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant ABW. A treatment dose of 4 mg/kg was used for reversal of deep NMB. |
| OG002 | Sugammadex ABW (2 mg/kg ABW Plus 4 mg/kg ABW) | Following administration of NMBA, participants who received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant ABW, and those who received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant ABW were pooled by dosing method across depth of NMB. Treatment doses of 2 mg/kg and 4 mg/kg were used for reversal of moderate NMB and deep NMB respectively. |
| OG003 | Sugammadex 2 mg/kg IBW | Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant IBW. A treatment dose of 2 mg/kg was used for reversal of moderate NMB. |
| OG004 | Sugammadex 4 mg/kg IBW | Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant IBW. A treatment dose of 4 mg/kg was used for reversal of deep NMB. |
| OG005 | Sugammadex IBW (2 mg/kg IBW Plus 4 mg/kg IBW) | Following administration of NMBA, participants who received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant IBW, and those who received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant IBW were pooled by dosing method across depth of NMB. Treatment doses of 2 mg/kg and 4 mg/kg were used for reversal of moderate NMB and deep NMB respectively. |
| OG006 | Neostigmine/Glycopyrrolate | Following administration of NMBA, participants received a single i.v. bolus containing both Neostigmine (50 µg/kg; up to 5 mg maximum dose) and Glycopyrrolate (10 µg/kg; up to 1 mg maximum dose) as determined utilizing participant ABW. Neostigmine/Glycopyrrolate was used for reversal of moderate NMB. Active comparator treatment for reversal for deep NMB was not available. |
|
|
|
| OG001 |
| Sugammadex 4 mg/kg ABW |
Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant ABW. A treatment dose of 4 mg/kg was used for reversal of deep NMB. |
| OG002 | Sugammadex ABW (2 mg/kg ABW Plus 4 mg/kg ABW) | Following administration of NMBA, participants who received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant ABW, and those who received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant ABW were pooled by dosing method across depth of NMB. Treatment doses of 2 mg/kg and 4 mg/kg were used for reversal of moderate NMB and deep NMB respectively. |
| OG003 | Sugammadex 2 mg/kg IBW | Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant IBW. A treatment dose of 2 mg/kg was used for reversal of moderate NMB. |
| OG004 | Sugammadex 4 mg/kg IBW | Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant IBW. A treatment dose of 4 mg/kg was used for reversal of deep NMB. |
| OG005 | Sugammadex IBW (2 mg/kg IBW Plus 4 mg/kg IBW) | Following administration of NMBA, participants who received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant IBW, and those who received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant IBW were pooled by dosing method across depth of NMB. Treatment doses of 2 mg/kg and 4 mg/kg were used for reversal of moderate NMB and deep NMB respectively. |
| OG006 | Neostigmine/Glycopyrrolate | Following administration of NMBA, participants received a single i.v. bolus containing both Neostigmine (50 µg/kg; up to 5 mg maximum dose) and Glycopyrrolate (10 µg/kg; up to 1 mg maximum dose) as determined utilizing participant ABW. Neostigmine/Glycopyrrolate was used for reversal of moderate NMB. Active comparator treatment for reversal for deep NMB was not available. |
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Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant ABW. A treatment dose of 4 mg/kg was used for reversal of deep NMB. |
| OG002 | Sugammadex ABW (2 mg/kg ABW Plus 4 mg/kg ABW) | Following administration of NMBA, participants who received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant ABW, and those who received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant ABW were pooled by dosing method across depth of NMB. Treatment doses of 2 mg/kg and 4 mg/kg were used for reversal of moderate NMB and deep NMB respectively. |
| OG003 | Sugammadex 2 mg/kg IBW | Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant IBW. A treatment dose of 2 mg/kg was used for reversal of moderate NMB. |
| OG004 | Sugammadex 4 mg/kg IBW | Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant IBW. A treatment dose of 4 mg/kg was used for reversal of deep NMB. |
| OG005 | Sugammadex IBW (2 mg/kg IBW Plus 4 mg/kg IBW) | Following administration of NMBA, participants who received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant IBW, and those who received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant IBW were pooled by dosing method across depth of NMB. Treatment doses of 2 mg/kg and 4 mg/kg were used for reversal of moderate NMB and deep NMB respectively. |
| OG006 | Neostigmine/Glycopyrrolate | Following administration of NMBA, participants received a single i.v. bolus containing both Neostigmine (50 µg/kg; up to 5 mg maximum dose) and Glycopyrrolate (10 µg/kg; up to 1 mg maximum dose) as determined utilizing participant ABW. Neostigmine/Glycopyrrolate was used for reversal of moderate NMB. Active comparator treatment for reversal for deep NMB was not available. |
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| OG001 | Sugammadex 4 mg/kg ABW | Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant ABW. A treatment dose of 4 mg/kg was used for reversal of deep NMB. |
| OG002 | Sugammadex ABW (2 mg/kg ABW Plus 4 mg/kg ABW) | Following administration of NMBA, participants who received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant ABW, and those who received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant ABW were pooled by dosing method across depth of NMB. Treatment doses of 2 mg/kg and 4 mg/kg were used for reversal of moderate NMB and deep NMB respectively. |
| OG003 | Sugammadex 2 mg/kg IBW | Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant IBW. A treatment dose of 2 mg/kg was used for reversal of moderate NMB. |
| OG004 | Sugammadex 4 mg/kg IBW | Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant IBW. A treatment dose of 4 mg/kg was used for reversal of deep NMB. |
| OG005 | Sugammadex IBW (2 mg/kg IBW Plus 4 mg/kg IBW) | Following administration of NMBA, participants who received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant IBW, and those who received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant IBW were pooled by dosing method across depth of NMB. Treatment doses of 2 mg/kg and 4 mg/kg were used for reversal of moderate NMB and deep NMB respectively. |
| OG006 | Neostigmine/Glycopyrrolate | Following administration of NMBA, participants received a single i.v. bolus containing both Neostigmine (50 µg/kg; up to 5 mg maximum dose) and Glycopyrrolate (10 µg/kg; up to 1 mg maximum dose) as determined utilizing participant ABW. Neostigmine/Glycopyrrolate was used for reversal of moderate NMB. Active comparator treatment for reversal for deep NMB was not available. |
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| OG001 | Sugammadex 4 mg/kg ABW | Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant ABW. A treatment dose of 4 mg/kg was used for reversal of deep NMB. |
| OG002 | Sugammadex ABW (2 mg/kg ABW Plus 4 mg/kg ABW) | Following administration of NMBA, participants who received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant ABW, and those who received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant ABW were pooled by dosing method across depth of NMB. Treatment doses of 2 mg/kg and 4 mg/kg were used for reversal of moderate NMB and deep NMB respectively. |
| OG003 | Sugammadex 2 mg/kg IBW | Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant IBW. A treatment dose of 2 mg/kg was used for reversal of moderate NMB. |
| OG004 | Sugammadex 4 mg/kg IBW | Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant IBW. A treatment dose of 4 mg/kg was used for reversal of deep NMB. |
| OG005 | Sugammadex IBW (2 mg/kg IBW Plus 4 mg/kg IBW) | Following administration of NMBA, participants who received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant IBW, and those who received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant IBW were pooled by dosing method across depth of NMB. Treatment doses of 2 mg/kg and 4 mg/kg were used for reversal of moderate NMB and deep NMB respectively. |
| OG006 | Neostigmine/Glycopyrrolate | Following administration of NMBA, participants received a single i.v. bolus containing both Neostigmine (50 µg/kg; up to 5 mg maximum dose) and Glycopyrrolate (10 µg/kg; up to 1 mg maximum dose) as determined utilizing participant ABW. Neostigmine/Glycopyrrolate was used for reversal of moderate NMB. Active comparator treatment for reversal for deep NMB was not available. |
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| OG001 | Sugammadex 4 mg/kg ABW | Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant ABW. A treatment dose of 4 mg/kg was used for reversal of deep NMB. |
| OG002 | Sugammadex ABW (2 mg/kg ABW Plus 4 mg/kg ABW) | Following administration of NMBA, participants who received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant ABW, and those who received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant ABW were pooled by dosing method across depth of NMB. Treatment doses of 2 mg/kg and 4 mg/kg were used for reversal of moderate NMB and deep NMB respectively. |
| OG003 | Sugammadex 2 mg/kg IBW | Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant IBW. A treatment dose of 2 mg/kg was used for reversal of moderate NMB. |
| OG004 | Sugammadex 4 mg/kg IBW | Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant IBW. A treatment dose of 4 mg/kg was used for reversal of deep NMB. |
| OG005 | Sugammadex IBW (2 mg/kg IBW Plus 4 mg/kg IBW) | Following administration of NMBA, participants who received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant IBW, and those who received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant IBW were pooled by dosing method across depth of NMB. Treatment doses of 2 mg/kg and 4 mg/kg were used for reversal of moderate NMB and deep NMB respectively. |
| OG006 | Neostigmine/Glycopyrrolate | Following administration of NMBA, participants received a single i.v. bolus containing both Neostigmine (50 µg/kg; up to 5 mg maximum dose) and Glycopyrrolate (10 µg/kg; up to 1 mg maximum dose) as determined utilizing participant ABW. Neostigmine/Glycopyrrolate was used for reversal of moderate NMB. Active comparator treatment for reversal for deep NMB was not available. |
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| OG001 | Sugammadex 4 mg/kg ABW | Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant ABW. A treatment dose of 4 mg/kg was used for reversal of deep NMB. |
| OG002 | Sugammadex ABW (2 mg/kg ABW Plus 4 mg/kg ABW) | Following administration of NMBA, participants who received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant ABW, and those who received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant ABW were pooled by dosing method across depth of NMB. Treatment doses of 2 mg/kg and 4 mg/kg were used for reversal of moderate NMB and deep NMB respectively. |
| OG003 | Sugammadex 2 mg/kg IBW | Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant IBW. A treatment dose of 2 mg/kg was used for reversal of moderate NMB. |
| OG004 | Sugammadex 4 mg/kg IBW | Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant IBW. A treatment dose of 4 mg/kg was used for reversal of deep NMB. |
| OG005 | Sugammadex IBW (2 mg/kg IBW Plus 4 mg/kg IBW) | Following administration of NMBA, participants who received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant IBW, and those who received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant IBW were pooled by dosing method across depth of NMB. Treatment doses of 2 mg/kg and 4 mg/kg were used for reversal of moderate NMB and deep NMB respectively. |
| OG006 | Neostigmine/Glycopyrrolate | Following administration of NMBA, participants received a single i.v. bolus containing both Neostigmine (50 µg/kg; up to 5 mg maximum dose) and Glycopyrrolate (10 µg/kg; up to 1 mg maximum dose) as determined utilizing participant ABW. Neostigmine/Glycopyrrolate was used for reversal of moderate NMB. Active comparator treatment for reversal for deep NMB was not available. |
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| OG001 | Sugammadex 4 mg/kg ABW | Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant ABW. A treatment dose of 4 mg/kg was used for reversal of deep NMB. |
| OG002 | Sugammadex ABW (2 mg/kg ABW Plus 4 mg/kg ABW) | Following administration of NMBA, participants who received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant ABW, and those who received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant ABW were pooled by dosing method across depth of NMB. Treatment doses of 2 mg/kg and 4 mg/kg were used for reversal of moderate NMB and deep NMB respectively. |
| OG003 | Sugammadex 2 mg/kg IBW | Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant IBW. A treatment dose of 2 mg/kg was used for reversal of moderate NMB. |
| OG004 | Sugammadex 4 mg/kg IBW | Following administration of NMBA, participants received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant IBW. A treatment dose of 4 mg/kg was used for reversal of deep NMB. |
| OG005 | Sugammadex IBW (2 mg/kg IBW Plus 4 mg/kg IBW) | Following administration of NMBA, participants who received a single i.v. bolus of Sugammadex at 2 mg/kg as determined utilizing participant IBW, and those who received a single i.v. bolus of Sugammadex at 4 mg/kg as determined utilizing participant IBW were pooled by dosing method across depth of NMB. Treatment doses of 2 mg/kg and 4 mg/kg were used for reversal of moderate NMB and deep NMB respectively. |
| OG006 | Neostigmine/Glycopyrrolate | Following administration of NMBA, participants received a single i.v. bolus containing both Neostigmine (50 µg/kg; up to 5 mg maximum dose) and Glycopyrrolate (10 µg/kg; up to 1 mg maximum dose) as determined utilizing participant ABW. Neostigmine/Glycopyrrolate was used for reversal of moderate NMB. Active comparator treatment for reversal for deep NMB was not available. |
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