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| ID | Type | Description | Link |
|---|---|---|---|
| MK-8616-169 | Other Identifier | MSD Protocol Number | |
| 2017-000693-11 | EudraCT Number |
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This study will evaluate the efficacy, safety, and pharmacokinetics (PK) of sugammadex (MK-8616) for reversal of both moderate and deep neuromuscular blockade (NMB) in pediatric participants aged birth to <2 years. The primary hypothesis of this study is that sugammadex is superior to neostigmine in reversing moderate NMB as measured by time to neuromuscular recovery.
This trial will be conducted in two parts: Part A and Part B. In Part A, PK sampling will be conducted to identify the pediatric dose providing sugammadex exposure comparable to the next oldest age cohort. For Part B participants, the efficacy of sugammadex (i.e. neuromuscular recovery / time to extubation) will be assessed. Further, safety analyses will be conducted in both Parts A and B. Following completion of Part A, an interim analysis (IA) of the PK and safety data will be performed. Once the appropriate doses are confirmed and safety data is assessed for the 2 doses of sugammadex, then Part B will commence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A. Sugammadex 2 mg/kg | Experimental | Participants received a single intravenous (IV) bolus of sugammadex at 2 mg/kg for moderate NMB reversal. |
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| Part A. Sugammadex 4 mg/kg | Experimental | Participants received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal. |
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| Part B. Sugammadex 2 mg/kg | Experimental | Participants received a single IV bolus of sugammadex at 2 mg/kg for moderate NMB reversal. |
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| Part B. Sugammadex 4 mg/kg | Experimental | Participants received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal. |
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| Part B. Neostigmine | Active Comparator | Participants received a single IV bolus containing neostigmine (50 μg/kg; up to 5 mg maximum dose) in combination with either glycopyrrolate (10 μg/kg) or atropine sulfate (20 μg/kg) based on availability and/or contraindications, for moderate NMB reversal. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sugammadex 2 mg/kg | Drug | For moderate NMB reversal, a single IV bolus of sugammadex (2 mg/kg) will be given after final dose of neuromuscular blocking agent (NMBA; rocuronium or vecuronium) and within 2 minutes of the reappearance of a second twitch (T2) in response to train-of-four (TOF) stimulations. |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUC0-inf) for Sugammadex | Pharmacokinetic (PK) blood samples were collected in Part A from pediatric participants at multiple collection times post administration of sugammadex using a sparse sampling approach and used to determine AUC0-inf for sugammadex. As pre-specified by the Statistical Analysis Plan (SAP) for the PK analysis, all PK parameters were analyzed and reported by Part A age cohort (birth to <27 days, 28 days to <3 months, 3 to <6 months, and 6 months to < 2 years) for each dose (2 mg and 4 mg). | Day 1: 2, 15, 30, 60, 240 to 360, and 600 to 720 minutes post-dose |
| Part A: Area Under the Plasma Concentration Time Curve up to the Interpolated Concentration at 1 Hour Post Dose (AUC0-1hr) for Sugammadex | PK blood samples were collected in Part A from pediatric participants at multiple collection times post administration of sugammadex using a sparse sampling approach and used to determine AUC0-1hr for sugammadex. As pre-specified by the SAP for the PK analysis, all PK parameters were analyzed and reported by Part A age cohort (birth to <27 days, 28 days to <3 months, 3 to <6 months, and 6 months to < 2 years) for each dose (2 mg and 4 mg). | Day 1: 2, 15, 30, and 60 minutes (1 hour) post-dose |
| Part A: Area Under the Plasma Concentration Time Curve up to the Interpolated Concentration at 4 Hours Post Dose (AUC0-4hr) for Sugammadex | PK blood samples were collected in Part A from pediatric participants at multiple collection times post administration of sugammadex using a sparse sampling approach and used to determine AUC0-4hr for sugammadex. As pre-specified by the SAP for the PK analysis, all PK parameters were analyzed and reported by Part A age cohort (birth to <27 days, 28 days to <3 months, 3 to <6 months, and 6 months to < 2 years) for each dose (2 mg and 4 mg). | Day 1: 2, 15, 30, 60, and 240 minutes (4 hours) post-dose |
| Part A: Maximum Plasma Concentration (Cmax) of Sugammadex |
| Measure | Description | Time Frame |
|---|---|---|
| Part B: Time to Extubation In Reversal of Moderate Block | Time to extubation was defined as the interval from administration of reversal agent to removal of the endotracheal tube. Monitoring of time to extubation during Part B (moderate block) was achieved using the Extubation Readiness Assessment, which evaluated and documented clinically relevant elements including neuromuscular recovery, mental status, return of spontaneous ventilation, adequate oxygenation, hemodynamically stabile, and core body temperature with "Yes"/"No" answers (no overall score or direction attributed). The Operating Room anesthesiologist or other trained personnel were responsible for assessing extubation readiness beginning about 1 minute after study treatment administration and reassessing every 60 seconds until time of extubation readiness was achieved. As pre-specified by the protocol, Time to Extubation was analyzed only in Part B under setting of moderate block, and Part A participants were not included in this analysis. |
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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 |
|---|---|---|---|---|---|---|
| Lucille Packard Children's Hospital ( Site 3008) | Palo Alto | California | 94304 | United States | ||
| Variety Children's Hospital D.B.A. Nicklaus Children's Hospital ( Site 3019) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40324166 | Result | Mensah-Osman E, Mukai Y, Wang A, Matuszczak M, Saldien V, Leibensperger H, Speek M, Locco A, Wrishko R, Gee A, Herring WJ; New Collective Author. Sugammadex for Reversal of Neuromuscular Blockade in Neonates and Infants Less than 2 Years Old: Results from a Phase IV Randomized Clinical Trial. Anesthesiology. 2025 Aug 1;143(2):300-312. doi: 10.1097/ALN.0000000000005535. Epub 2025 May 5. |
| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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50 participants were allocated to moderate block and reversal (2 mg/kg) or deep block and reversal (4 mg/kg) with sugammadex in Part A. 95 participants were randomized in Part B to moderate block and reversal (2 mg/kg) with sugammadex, deep block and reversal (4 mg/kg) with sugammadex, or moderate block and reversal with neostigmine (50 μg/kg).
145 pediatric participants between the ages of birth and <2 years undergoing a procedure requiring a neuromuscular blocking agent (NMBA) for either moderate or deep neuromuscular blockade (NMB) were enrolled in this study. Participants were enrolled in 4 age cohorts: birth to 27 days, 28 days to <3 months, 3 months to <6 months, and 6 months to <2 years.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A: Sugammadex 2 mg/kg | Participants received a single intravenous (IV) bolus of sugammadex at 2 mg/kg for moderate NMB reversal. |
| FG001 | Part A: Sugammadex 4 mg/kg | Participants received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal. |
| 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 27, 2022 |
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Part A will be open-label, while Part B will be double-blinded.
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| Sugammadex 4 mg/kg | Drug | For deep NMB reversal, a single IV bolus of sugammadex (4 mg/kg) will be given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of detection of a target of 1 to 2 post-tetanic counts and no response to TOF stimulations (TOF=0). |
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| Neostigmine + Glycopyrrolate | Drug | For moderate NMB reversal, a single i.v. bolus containing both neostigmine (50 μg/kg; up to 5 mg maximum dose) as well as glycopyrrolate (10 μg/kg) will be given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of the reappearance of T2 in response to TOF stimulations. |
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| Neostigmine + Atropine | Drug | For moderate NMB reversal, a single i.v. bolus containing both neostigmine (50 μg/kg; up to 5 mg maximum dose) as well as atropine (20 μg/kg) will be given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of the reappearance of T2 in response to TOF stimulations. |
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PK blood samples were collected in Part A from pediatric participants at multiple collection times post administration of sugammadex using a sparse sampling approach and used to determine Cmax for sugammadex. As pre-specified by the SAP for the PK analysis, all PK parameters were analyzed and reported by Part A age cohort (birth to <27 days, 28 days to <3 months, 3 to <6 months, and 6 months to < 2 years) for each dose (2 mg and 4 mg).
| Day 1: 2, 15, 30, 60, 240 to 360, and 600 to 720 minutes post-dose |
| Part A: Plasma Clearance (CL) of Sugammadex | PK blood samples were collected in Part A from pediatric participants at multiple collection times post administration of sugammadex using a sparse sampling approach and used to determine CL for sugammadex. As pre-specified by the SAP for the PK analysis, all PK parameters were analyzed and reported by Part A age cohort (birth to <27 days, 28 days to <3 months, 3 to <6 months, and 6 months to < 2 years) for each dose (2 mg and 4 mg). | Day 1: 2, 15, 30, 60, 240 to 360, and 600 to 720 minutes post-dose |
| Part A: Apparent Volume of Distribution (Vd) for Sugammadex | PK blood samples were collected in Part A from pediatric participants at multiple collection times post administration of sugammadex using a sparse sampling approach and used to determine Vd for sugammadex. As pre-specified by the SAP for the PK analysis, all PK parameters were analyzed and reported by Part A age cohort (birth to <27 days, 28 days to <3 months, 3 to <6 months, and 6 months to < 2 years) for each dose (2 mg and 4 mg). | Day 1: 2, 15, 30, 60, 240 to 360, and 600 to 720 minutes post-dose |
| Apparent Volume of Distribution at Steady State (Vss) for Sugammadex | PK blood samples were collected in Part A from pediatric participants at multiple collection times post administration of sugammadex using a sparse sampling approach and used to determine Vss for sugammadex. As pre-specified by the SAP for the PK analysis, all PK parameters were analyzed and reported by Part A age cohort (birth to <27 days, 28 days to <3 months, 3 to <6 months, and 6 months to < 2 years) for each dose (2 mg and 4 mg). | Day 1: 2, 15, 30, 60, 240 to 360, and 600 to 720 minutes post-dose |
| Part A: Half-Life (t1/2) of Sugammadex in Plasma | PK blood samples were collected in Part A from pediatric participants at multiple collection times post administration of sugammadex using a sparse sampling approach and used to determine t½ for sugammadex. As pre-specified by the SAP for the PK analysis, all PK parameters were analyzed and reported by Part A age cohort (birth to <27 days, 28 days to <3 months, 3 to <6 months, and 6 months to < 2 years) for each dose (2 mg and 4 mg). | Day 1: 2, 15, 30, 60, 240 to 360, and 600 to 720 minutes post-dose |
| Part B: Time to Neuromuscular Recovery (TTNMR) In Reversal of Moderate Block | Time to neuromuscular recovery was defined as the interval from administration of reversal agent to time to neuromuscular recovery. TTNMR could be assessed by 1 of 4 methods selected by the investigator, based on their judgment of what was technically feasible and clinically appropriate for the participant's procedure. These methods were inclusive of both clinical signs (head lift or hip flexion) and neuromuscular transmission monitoring using either a standard peripheral nerve stimulator or the technically challenging quantitative neuromuscular monitoring to train-of-four (TOF) ratio ≥0.9. As pre-specified by the protocol and SAP, TTNMR was analyzed only in Part B participants under the setting of moderate block for comparison of sugammadex 2 mg to neostigmine. | Within Day 1 |
| Parts A and B: Percentage of Participants With Adverse Events (AEs) Up To 7 Days Post Administration of Study Medication | An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. As pre-specified by the protocol and SAP, the primary analysis of safety combined data across Part A and Part B (and across age cohorts) and included all AEs that occurred up to 7 days post administration of study medication. The percentage of participants with an AE was reported by treatment and dose received. | Up to Day 7 |
| Within Day 1 |
| Miami |
| Florida |
| 33155 |
| United States |
| OU Medical Center ( Site 3005) | Oklahoma City | Oklahoma | 73104 | United States |
| The Children's Hospital of Philadelphia ( Site 3021) | Philadelphia | Pennsylvania | 19104 | United States |
| Children's Hospital of Pittsburgh UPMC ( Site 3017) | Pittsburgh | Pennsylvania | 15224 | United States |
| McGovern Medical School at UT Health/ Memorial Hermann ( Site 3014) | Houston | Texas | 77030 | United States |
| University of Vermont Medical Center ( Site 3013) | Burlington | Vermont | 05401 | United States |
| The Children s Hospital at Westmead ( Site 3805) | Westmead | New South Wales | 2145 | Australia |
| Queensland Children s Hospital ( Site 3806) | South Brisbane | Queensland | 4101 | Australia |
| Royal Childrens Hospital Melbourne ( Site 3801) | Parkville | Victoria | 3052 | Australia |
| Universitaire Ziekenhuis Antwerpen - UZA ( Site 3200) | Edegem | Antwerpen | 2650 | Belgium |
| UZ Brussel ( Site 3201) | Brussels | Bruxelles-Capitale, Region de | 1090 | Belgium |
| UZ Leuven - Campus Gasthuisberg ( Site 3202) | Leuven | Vlaams-Brabant | 3000 | Belgium |
| Hospital Pequeno Principe ( Site 3826) | Curitiba | Paraná | 80250-060 | Brazil |
| Hospital Tacchini ( Site 3827) | Bento Gonçalves | Rio Grande do Sul | 95700-084 | Brazil |
| Instituto da Crianca do Hospital das Clinicas-FMUSP ( Site 3825) | São Paulo | 05403-900 | Brazil |
| Rigshospitalet ( Site 3250) | Copenhagen | Capital Region | 2100 | Denmark |
| New Childrens Hospital ( Site 3750) | Helsinki | Uusimaa | 00029 | Finland |
| C.H.R.U. de Lille. Hopital Jeanne de Flandres ( Site 3304) | Lille | Nord | 59000 | France |
| Unidad de Cirugía Cardiovascular ( Site 4126) | Guatemala City | 01011 | Guatemala |
| Szegedi Tudomanyegyetem ( Site 4201) | Szeged | Csongrád megye | 6720 | Hungary |
| Debreceni Egyetem Klinikai Kozpont ( Site 4200) | Debrecen | 4032 | Hungary |
| Sarawak General Hospital ( Site 3877) | Kuching | Sarawak | 93586 | Malaysia |
| Women and Children Hospital Kuala Lumpur (Hospital Tunku Azizah) ( Site 3875) | Kuala Lumpur | 50300 | Malaysia |
| University Malaya Medical Centre. ( Site 3876) | Kuala Lumpur | 59100 | Malaysia |
| Hospital General de Zona No. 1 ( Site 4153) | Ciudad de Villa de Álvarez | Colima | 28984 | Mexico |
| Centenario Hospital Miguel Hidalgo-Pediatrics Department ( Site 4152) | Aguascalientes | 20259 | Mexico |
| Radboud University Medical Center ( Site 4226) | Nijmegen | Gelderland | 6525 GA | Netherlands |
| Erasmus University Medical Center ( Site 4225) | Rotterdam | South Holland | 3015 GD | Netherlands |
| University Medical Center Groningen ( Site 4227) | Groningen | 9713 GZ | Netherlands |
| Wilhelmina Kinderziekenhuis ( Site 4228) | Utrecht | 3584 EA | Netherlands |
| Instituto Nacional Cardiovascular Incor ( Site 3928) | Lima | 15072 | Peru |
| Scientific Research Institute Complex Problems Cardiovascular Disease ( Site 4288) | Kemerovo | Kemerovo Oblast | 650002 | Russia |
| NMRC Obstetrics Gynecology and Perinatology n.a. V.I. Kulakov ( Site 4287) | Moscow | Moscow | 117997 | Russia |
| Pediatric Hematology Oncology and Immunology Centre n.a. D.Rogachev. ( Site 4275) | Moscow | Moscow | 117997 | Russia |
| Children City Clinical Hospital 13 n.a N.F.Filatov ( Site 4285) | Moscow | Moscow | 123001 | Russia |
| Children City Clinical Hospital #9 n.a. G.N.Speransky ( Site 4290) | Moscow | Moscow | 123317 | Russia |
| Scientific-Research Clinical Pediatric Institution n.a. Veltischev ( Site 4276) | Moscow | Moscow | 125412 | Russia |
| St.Petersburg State Pediatric Medical University ( Site 4281) | Saint Petersburg | Sankt-Peterburg | 194100 | Russia |
| FG002 | Part B: Sugammadex 2 mg/kg | Participants received a single IV bolus of sugammadex at 2 mg/kg for moderate NMB reversal. |
| FG003 | Part B: Sugammadex 4 mg/kg | Participants received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal. |
| FG004 | Part B: Neostigmine + (Glycopyrrolate or Atropine) | Participants received a single IV bolus containing neostigmine (50 μg/kg; up to 5 mg maximum dose) in combination with either glycopyrrolate (10 μg/kg) or atropine sulfate (20 μg/kg) based on availability and/or contraindications, for moderate NMB reversal. |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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The population used for Baseline Characteristics was the "All Participants Allocated (Part A)/Randomized (Part B) Population", with the exception of the "Protocol-defined Age Cohorts" characteristic and "Type of Neuromuscular Blocking Agent (NMBA)" Characteristic, which were reported per protocol for the "All Participants as Treated" (APaT) population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part A: Sugammadex 2 mg/kg | Participants received a single intravenous (IV) bolus of sugammadex at 2 mg/kg. |
| BG001 | Part A: Sugammadex 4 mg/kg | Participants received a single IV bolus of sugammadex at 4 mg/kg. |
| BG002 | Part B: Sugammadex 2 mg/kg | Participants received a single IV bolus of sugammadex at 2 mg/kg. |
| BG003 | Part B: Sugammadex 4 mg/kg | Participants received a single IV bolus of sugammadex at 4 mg/kg. |
| BG004 | Part B: Neostigmine + (Glycopyrrolate or Atropine) | Participants received a single IV bolus containing neostigmine (50 μg/kg; up to 5 mg maximum dose) in combination with either glycopyrrolate (10 μg/kg) or atropine sulfate (20 μg/kg) based on availability and/or contraindications. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | days |
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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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| Protocol-defined Age Cohorts (All Participants As Treated Population) | Per protocol, Protocol-defined Age Cohorts were reported for the APaT Population and used as a stratification factor for statistical analyses. | "Protocol-defined Age Cohorts" characteristic was reported per protocol for the APaT population. A single participant assigned to the Sugammadex 2 mg/kg "3 months to <6 months age cohort" (N=2) was excluded from the APaT population due to missing IV dose information, but included in the corresponding cohort of the PK Evaluable Population (N=3). | Count of Participants | Participants |
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| Type of Neuromuscular Blocking Agent [NMBA] (All Participants As Treated Population) | Per protocol, Type of NMBA (rocuronium and vecuronium) was reported for the APaT Population and used as a stratification factor for statistical analyses. | "Type of Neuromuscular Blocking Agent (NMBA)" characteristic was reported per protocol for the APaT population. | Count of Participants | Participants |
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| EudraCT Age Categories | EMA pre-defined age categories that are part of the Clinical Trial Application (CTA). | 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 | Part A: Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUC0-inf) for Sugammadex | Pharmacokinetic (PK) blood samples were collected in Part A from pediatric participants at multiple collection times post administration of sugammadex using a sparse sampling approach and used to determine AUC0-inf for sugammadex. As pre-specified by the Statistical Analysis Plan (SAP) for the PK analysis, all PK parameters were analyzed and reported by Part A age cohort (birth to <27 days, 28 days to <3 months, 3 to <6 months, and 6 months to < 2 years) for each dose (2 mg and 4 mg). | All pediatric participants in Part A who received at least 1 dose of sugammadex and had at least 5 samples at the time points of interest were analyzed per protocol by age cohort. One participant in the Sugammadex 2 mg/kg "3 months to <6 months age cohort" was evaluated for PK but excluded from the APaT population due to missing IV dose information. Per protocol, Part B participants were not analyzed for PK. | Posted | Geometric Mean | 95% Confidence Interval | Hour (hr)*ug/mL | Day 1: 2, 15, 30, 60, 240 to 360, and 600 to 720 minutes post-dose |
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| Primary | Part A: Area Under the Plasma Concentration Time Curve up to the Interpolated Concentration at 1 Hour Post Dose (AUC0-1hr) for Sugammadex | PK blood samples were collected in Part A from pediatric participants at multiple collection times post administration of sugammadex using a sparse sampling approach and used to determine AUC0-1hr for sugammadex. As pre-specified by the SAP for the PK analysis, all PK parameters were analyzed and reported by Part A age cohort (birth to <27 days, 28 days to <3 months, 3 to <6 months, and 6 months to < 2 years) for each dose (2 mg and 4 mg). | All pediatric participants in Part A who received at least 1 dose of sugammadex and had at least 5 samples at the time points of interest were analyzed per protocol by age cohort. One participant in the Sugammadex 2 mg/kg "3 months to <6 months age cohort" was evaluated for PK but excluded from the APaT population due to missing IV dose information. Per protocol, Part B participants were not analyzed for PK. | Posted | Geometric Mean | 95% Confidence Interval | hr*ug/mL | Day 1: 2, 15, 30, and 60 minutes (1 hour) post-dose |
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| Primary | Part A: Area Under the Plasma Concentration Time Curve up to the Interpolated Concentration at 4 Hours Post Dose (AUC0-4hr) for Sugammadex | PK blood samples were collected in Part A from pediatric participants at multiple collection times post administration of sugammadex using a sparse sampling approach and used to determine AUC0-4hr for sugammadex. As pre-specified by the SAP for the PK analysis, all PK parameters were analyzed and reported by Part A age cohort (birth to <27 days, 28 days to <3 months, 3 to <6 months, and 6 months to < 2 years) for each dose (2 mg and 4 mg). | All pediatric participants in Part A who received at least 1 dose of sugammadex and had at least 5 samples at the time points of interest were analyzed per protocol by age cohort. One participant in the Sugammadex 2 mg/kg "3 months to <6 months age cohort" was evaluated for PK but excluded from the APaT population due to missing IV dose information. Per protocol, Part B participants were not analyzed for PK. | Posted | Geometric Mean | 95% Confidence Interval | hr*ug/mL | Day 1: 2, 15, 30, 60, and 240 minutes (4 hours) post-dose |
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| Primary | Part A: Maximum Plasma Concentration (Cmax) of Sugammadex | PK blood samples were collected in Part A from pediatric participants at multiple collection times post administration of sugammadex using a sparse sampling approach and used to determine Cmax for sugammadex. As pre-specified by the SAP for the PK analysis, all PK parameters were analyzed and reported by Part A age cohort (birth to <27 days, 28 days to <3 months, 3 to <6 months, and 6 months to < 2 years) for each dose (2 mg and 4 mg). | All pediatric participants in Part A who received at least 1 dose of sugammadex and had at least 5 samples at the time points of interest were analyzed per protocol by age cohort. One participant in the Sugammadex 2 mg/kg "3 months to <6 months age cohort" was evaluated for PK but excluded from the APaT population due to missing IV dose information. Per protocol, Part B participants were not analyzed for PK. | Posted | Geometric Mean | 95% Confidence Interval | ug/mL | Day 1: 2, 15, 30, 60, 240 to 360, and 600 to 720 minutes post-dose |
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| Primary | Part A: Plasma Clearance (CL) of Sugammadex | PK blood samples were collected in Part A from pediatric participants at multiple collection times post administration of sugammadex using a sparse sampling approach and used to determine CL for sugammadex. As pre-specified by the SAP for the PK analysis, all PK parameters were analyzed and reported by Part A age cohort (birth to <27 days, 28 days to <3 months, 3 to <6 months, and 6 months to < 2 years) for each dose (2 mg and 4 mg). | All pediatric participants in Part A who received at least 1 dose of sugammadex and had at least 5 samples at the time points of interest were analyzed per protocol by age cohort. One participant in the Sugammadex 2 mg/kg "3 months to <6 months age cohort" was evaluated for PK but excluded from the APaT population due to missing IV dose information. Per protocol, Part B participants were not analyzed for PK. | Posted | Geometric Mean | 95% Confidence Interval | Liters/hour | Day 1: 2, 15, 30, 60, 240 to 360, and 600 to 720 minutes post-dose |
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| Primary | Part A: Apparent Volume of Distribution (Vd) for Sugammadex | PK blood samples were collected in Part A from pediatric participants at multiple collection times post administration of sugammadex using a sparse sampling approach and used to determine Vd for sugammadex. As pre-specified by the SAP for the PK analysis, all PK parameters were analyzed and reported by Part A age cohort (birth to <27 days, 28 days to <3 months, 3 to <6 months, and 6 months to < 2 years) for each dose (2 mg and 4 mg). | All pediatric participants in Part A who received at least 1 dose of sugammadex and had at least 5 samples at the time points of interest were analyzed per protocol by age cohort. One participant in the Sugammadex 2 mg/kg "3 months to <6 months age cohort" was evaluated for PK but excluded from the APaT population due to missing IV dose information. Per protocol, Part B participants were not analyzed for PK. | Posted | Geometric Mean | 95% Confidence Interval | Liters (L) | Day 1: 2, 15, 30, 60, 240 to 360, and 600 to 720 minutes post-dose |
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| Primary | Apparent Volume of Distribution at Steady State (Vss) for Sugammadex | PK blood samples were collected in Part A from pediatric participants at multiple collection times post administration of sugammadex using a sparse sampling approach and used to determine Vss for sugammadex. As pre-specified by the SAP for the PK analysis, all PK parameters were analyzed and reported by Part A age cohort (birth to <27 days, 28 days to <3 months, 3 to <6 months, and 6 months to < 2 years) for each dose (2 mg and 4 mg). | All pediatric participants in Part A who received at least 1 dose of sugammadex and had at least 5 samples at the time points of interest were analyzed per protocol by age cohort. One participant in the Sugammadex 2 mg/kg "3 months to <6 months age cohort" was evaluated for PK but excluded from the APaT population due to missing IV dose information. Per protocol, Part B participants were not analyzed for PK. | Posted | Geometric Mean | 95% Confidence Interval | Liters (L) | Day 1: 2, 15, 30, 60, 240 to 360, and 600 to 720 minutes post-dose |
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| Primary | Part A: Half-Life (t1/2) of Sugammadex in Plasma | PK blood samples were collected in Part A from pediatric participants at multiple collection times post administration of sugammadex using a sparse sampling approach and used to determine t½ for sugammadex. As pre-specified by the SAP for the PK analysis, all PK parameters were analyzed and reported by Part A age cohort (birth to <27 days, 28 days to <3 months, 3 to <6 months, and 6 months to < 2 years) for each dose (2 mg and 4 mg). | All pediatric participants in Part A who received at least 1 dose of sugammadex and had at least 5 samples at the time points of interest were analyzed per protocol by age cohort. One participant in the Sugammadex 2 mg/kg "3 months to <6 months age cohort" was evaluated for PK but excluded from the APaT population due to missing IV dose information. Per protocol, Part B participants were not analyzed for PK. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours (h) | Day 1: 2, 15, 30, 60, 240 to 360, and 600 to 720 minutes post-dose |
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| Primary | Part B: Time to Neuromuscular Recovery (TTNMR) In Reversal of Moderate Block | Time to neuromuscular recovery was defined as the interval from administration of reversal agent to time to neuromuscular recovery. TTNMR could be assessed by 1 of 4 methods selected by the investigator, based on their judgment of what was technically feasible and clinically appropriate for the participant's procedure. These methods were inclusive of both clinical signs (head lift or hip flexion) and neuromuscular transmission monitoring using either a standard peripheral nerve stimulator or the technically challenging quantitative neuromuscular monitoring to train-of-four (TOF) ratio ≥0.9. As pre-specified by the protocol and SAP, TTNMR was analyzed only in Part B participants under the setting of moderate block for comparison of sugammadex 2 mg to neostigmine. | All randomized participants in Part B who received ≥1 dose of study treatment for moderate NMB reversal (i.e. Sugammadex 2 mg/kg or Neostigmine + [Glycopyrrolate or Atropine]) and with available TTNMR data were analyzed. Per the protocol objective, no formal test for efficacy with comparison to neostigmine was done for Part A and Part B deep block, thus Part A and Part B 4 mg/kg participants were not included in this analysis. | Posted | Median | 95% Confidence Interval | Minutes | Within Day 1 |
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| Primary | Parts A and B: Percentage of Participants With Adverse Events (AEs) Up To 7 Days Post Administration of Study Medication | An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. As pre-specified by the protocol and SAP, the primary analysis of safety combined data across Part A and Part B (and across age cohorts) and included all AEs that occurred up to 7 days post administration of study medication. The percentage of participants with an AE was reported by treatment and dose received. | All enrolled/randomized participants from both Part A and Part B (combined per protocol) who received at least 1 dose of study treatment were analyzed. | Posted | Number | Percentage of Participants | Up to Day 7 |
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| Secondary | Part B: Time to Extubation In Reversal of Moderate Block | Time to extubation was defined as the interval from administration of reversal agent to removal of the endotracheal tube. Monitoring of time to extubation during Part B (moderate block) was achieved using the Extubation Readiness Assessment, which evaluated and documented clinically relevant elements including neuromuscular recovery, mental status, return of spontaneous ventilation, adequate oxygenation, hemodynamically stabile, and core body temperature with "Yes"/"No" answers (no overall score or direction attributed). The Operating Room anesthesiologist or other trained personnel were responsible for assessing extubation readiness beginning about 1 minute after study treatment administration and reassessing every 60 seconds until time of extubation readiness was achieved. As pre-specified by the protocol, Time to Extubation was analyzed only in Part B under setting of moderate block, and Part A participants were not included in this analysis. | All randomized participants in Part B who received ≥1 dose of study treatment for moderate NMB reversal (i.e. Sugammadex 2 mg/kg or Neostigmine + [Glycopyrrolate or Atropine]) were analyzed. Per the protocol objective, no formal test for efficacy with comparison to neostigmine was done for Part A and Part B deep block, thus Part A and Part B 4 mg/kg participants were not included in this analysis. | Posted | Median | 95% Confidence Interval | Minutes | Within Day 1 |
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Up to Day 14
All-Cause Mortality includes all allocated (Part A)/randomized (Part B) participants. Serious adverse events (SAEs) and Nonserious AEs include all allocated/randomized participants who received ≥1 dose of study drug.
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 | Part A: Sugammadex 2 mg/kg | Participants received a single intravenous (IV) bolus of sugammadex at 2 mg/kg. | 0 | 16 | 1 | 15 | 11 | 15 |
| EG001 | Part A: Sugammadex 4 mg/kg | Participants received a single IV bolus of sugammadex at 4 mg/kg. | 0 | 34 | 1 | 32 | 22 | 32 |
| EG002 | Part B: Sugammadex 2 mg/kg | Participants received a single IV bolus of sugammadex at 2 mg/kg. | 0 | 31 | 3 | 29 | 19 | 29 |
| EG003 | Part B: Sugammadex 4 mg/kg | Participants received a single IV bolus of sugammadex at 4 mg/kg. | 0 | 32 | 1 | 31 | 17 | 31 |
| EG004 | Part B: Neostigmine + (Glycopyrrolate or Atropine) | Participants received a single IV bolus containing neostigmine (50 μg/kg; up to 5 mg maximum dose) in combination with either glycopyrrolate (10 μg/kg) or atropine sulfate (20 μg/kg) based on availability and/or contraindications. | 0 | 32 | 0 | 31 | 16 | 31 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Diarrhoea haemorrhagic | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Pyelonephritis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Anaesthetic complication | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
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| Device mechanical issue | Product Issues | MedDRA 26.1 | Systematic Assessment |
| |
| Urinoma | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Teething | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.1 | Systematic Assessment |
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| Device related sepsis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| Postoperative wound infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| Post procedural oedema | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
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| Procedural nausea | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Procedural vomiting | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
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| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
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| Bradypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Irregular breathing | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Respiratory depression | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
|
In accordance with standard editorial and ethical practice, the Sponsor will generally support publication of multicenter studies only in their entirety and not as individual site data. If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. Authorship will be determined by mutual agreement and in line with International Committee of Medical Journal Editors authorship requirements.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| Aug 13, 2024 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000077122 | Sugammadex |
| D009388 | Neostigmine |
| D006024 | Glycopyrrolate |
| D001285 | Atropine |
| 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 |
| D001286 | Atropine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
Not provided
Not provided
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Participants aged 6 months to < 2 years received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal. |
| Geometric Mean Ratio (GMR) |
| 1.41 |
| 2-Sided |
| 90 |
| 1.00 |
| 1.98 |
| Other |
| 2 mg/kg AUC0-inf GMR = 3 to < 6 months AUC0-inf GM / 6 months to < 2 years AUC0-inf GM. | Geometric Mean Ratio (GMR) | 0.82 | 2-Sided | 90 | 0.60 | 1.11 | Other |
| 4 mg/kg AUC0-inf GMR = Birth to 27 days AUC0-inf GM / 28 days to < 3 months AUC0-inf GM. | Geometric Mean Ratio (GMR) | 1.23 | 2-Sided | 90 | 0.96 | 1.56 | Other |
| 4 mg/kg AUC0-inf GMR = 28 days to < 3 months AUC0-inf GM / 3 to < 6 months AUC0-inf GM. | Geometric Mean Ratio (GMR) | 1.29 | 2-Sided | 90 | 1.03 | 1.62 | Other |
| 4 mg/kg AUC0-inf GMR = 3 to < 6 months AUC0-inf GM / 6 months to < 2 years AUC0-inf GM. | Geometric Mean Ratio (GMR) | 0.89 | 2-Sided | 90 | 0.70 | 1.13 | Other |
| OG002 | Part A: Sugammadex 2 mg/kg [3 to < 6 Months] | Participants aged 3 to < 6 months received a single IV bolus of sugammadex at 2 mg/kg for moderate NMB reversal. |
| OG003 | Part A: Sugammadex 2 mg/kg [6 Months to < 2 Years] | Participants aged 6 months to < 2 years received a single IV bolus of sugammadex at 2 mg/kg for moderate NMB reversal. |
| OG004 | Part A: Sugammadex 4 mg/kg [Birth to 27 Days] | Participants aged birth to 27 days received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal. |
| OG005 | Part A: Sugammadex 4 mg/kg [28 Days to <3 Months] | Participants aged 28 days to <3 months received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal. |
| OG006 | Part A: Sugammadex 4 mg/kg [3 to < 6 Months] | Participants aged 3 to < 6 months received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal. |
| OG007 | Part A: Sugammadex 4 mg/kg [6 Months to < 2 Years] | Participants aged 6 months to < 2 years received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal. |
|
|
|
| OG002 | Part A: Sugammadex 2 mg/kg [3 to < 6 Months] | Participants aged 3 to < 6 months received a single IV bolus of sugammadex at 2 mg/kg for moderate NMB reversal. |
| OG003 | Part A: Sugammadex 2 mg/kg [6 Months to < 2 Years] | Participants aged 6 months to < 2 years received a single IV bolus of sugammadex at 2 mg/kg for moderate NMB reversal. |
| OG004 | Part A: Sugammadex 4 mg/kg [Birth to 27 Days] | Participants aged birth to 27 days received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal. |
| OG005 | Part A: Sugammadex 4 mg/kg [28 Days to <3 Months] | Participants aged 28 days to <3 months received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal. |
| OG006 | Part A: Sugammadex 4 mg/kg [3 to < 6 Months] | Participants aged 3 to < 6 months received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal. |
| OG007 | Part A: Sugammadex 4 mg/kg [6 Months to < 2 Years] | Participants aged 6 months to < 2 years received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal. |
|
|
| OG002 | Part A: Sugammadex 2 mg/kg [3 to < 6 Months] | Participants aged 3 to < 6 months received a single IV bolus of sugammadex at 2 mg/kg for moderate NMB reversal. |
| OG003 | Part A: Sugammadex 2 mg/kg [6 Months to < 2 Years] | Participants aged 6 months to < 2 years received a single IV bolus of sugammadex at 2 mg/kg for moderate NMB reversal. |
| OG004 | Part A: Sugammadex 4 mg/kg [Birth to 27 Days] | Participants aged birth to 27 days received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal. |
| OG005 | Part A: Sugammadex 4 mg/kg [28 Days to <3 Months] | Participants aged 28 days to <3 months received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal. |
| OG006 | Part A: Sugammadex 4 mg/kg [3 to < 6 Months] | Participants aged 3 to < 6 months received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal. |
| OG007 | Part A: Sugammadex 4 mg/kg [6 Months to < 2 Years] | Participants aged 6 months to < 2 years received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal. |
|
|
|
| OG002 |
| Part A: Sugammadex 2 mg/kg [3 to < 6 Months] |
Participants aged 3 to < 6 months received a single IV bolus of sugammadex at 2 mg/kg for moderate NMB reversal. |
| OG003 | Part A: Sugammadex 2 mg/kg [6 Months to < 2 Years] | Participants aged 6 months to < 2 years received a single IV bolus of sugammadex at 2 mg/kg for moderate NMB reversal. |
| OG004 | Part A: Sugammadex 4 mg/kg [Birth to 27 Days] | Participants aged birth to 27 days received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal. |
| OG005 | Part A: Sugammadex 4 mg/kg [28 Days to <3 Months] | Participants aged 28 days to <3 months received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal. |
| OG006 | Part A: Sugammadex 4 mg/kg [3 to < 6 Months] | Participants aged 3 to < 6 months received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal. |
| OG007 | Part A: Sugammadex 4 mg/kg [6 Months to < 2 Years] | Participants aged 6 months to < 2 years received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal. |
|
|
| OG002 | Part A: Sugammadex 2 mg/kg [3 to < 6 Months] | Participants aged 3 to < 6 months received a single IV bolus of sugammadex at 2 mg/kg for moderate NMB reversal. |
| OG003 | Part A: Sugammadex 2 mg/kg [6 Months to < 2 Years] | Participants aged 6 months to < 2 years received a single IV bolus of sugammadex at 2 mg/kg for moderate NMB reversal. |
| OG004 | Part A: Sugammadex 4 mg/kg [Birth to 27 Days] | Participants aged birth to 27 days received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal. |
| OG005 | Part A: Sugammadex 4 mg/kg [28 Days to <3 Months] | Participants aged 28 days to <3 months received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal. |
| OG006 | Part A: Sugammadex 4 mg/kg [3 to < 6 Months] | Participants aged 3 to < 6 months received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal. |
| OG007 | Part A: Sugammadex 4 mg/kg [6 Months to < 2 Years] | Participants aged 6 months to < 2 years received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal. |
|
|
| OG002 | Part A: Sugammadex 2 mg/kg [3 to < 6 Months] | Participants aged 3 to < 6 months received a single IV bolus of sugammadex at 2 mg/kg for moderate NMB reversal. |
| OG003 | Part A: Sugammadex 2 mg/kg [6 Months to < 2 Years] | Participants aged 6 months to < 2 years received a single IV bolus of sugammadex at 2 mg/kg for moderate NMB reversal. |
| OG004 | Part A: Sugammadex 4 mg/kg [Birth to 27 Days] | Participants aged birth to 27 days received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal. |
| OG005 | Part A: Sugammadex 4 mg/kg [28 Days to <3 Months] | Participants aged 28 days to <3 months received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal. |
| OG006 | Part A: Sugammadex 4 mg/kg [3 to < 6 Months] | Participants aged 3 to < 6 months received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal. |
| OG007 | Part A: Sugammadex 4 mg/kg [6 Months to < 2 Years] | Participants aged 6 months to < 2 years received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal. |
|
|
| OG002 | Part A: Sugammadex 2 mg/kg [3 to < 6 Months] | Participants aged 3 to < 6 months received a single IV bolus of sugammadex at 2 mg/kg for moderate NMB reversal. |
| OG003 | Part A: Sugammadex 2 mg/kg [6 Months to < 2 Years] | Participants aged 6 months to < 2 years received a single IV bolus of sugammadex at 2 mg/kg for moderate NMB reversal. |
| OG004 | Part A: Sugammadex 4 mg/kg [Birth to 27 Days] | Participants aged birth to 27 days received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal. |
| OG005 | Part A: Sugammadex 4 mg/kg [28 Days to <3 Months] | Participants aged 28 days to <3 months received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal. |
| OG006 | Part A: Sugammadex 4 mg/kg [3 to < 6 Months] | Participants aged 3 to < 6 months received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal. |
| OG007 | Part A: Sugammadex 4 mg/kg [6 Months to < 2 Years] | Participants aged 6 months to < 2 years received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal. |
|
|
Participants received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal. |
| OG002 | Part B: Sugammadex 2 mg/kg | Participants received a single IV bolus of sugammadex at 2 mg/kg for moderate NMB reversal. |
| OG003 | Part B: Sugammadex 4 mg/kg | Participants received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal. |
| OG004 | Part B: Neostigmine + (Glycopyrrolate or Atropine) | Participants received a single IV bolus containing neostigmine (50 μg/kg; up to 5 mg maximum dose) in combination with either glycopyrrolate (10 μg/kg) or atropine sulfate (20 μg/kg) based on availability and/or contraindications, for moderate NMB reversal. |
|
|
|
Participants received a single IV bolus containing neostigmine (50 μg/kg; up to 5 mg maximum dose) in combination with either glycopyrrolate (10 μg/kg) or atropine sulfate (20 μg/kg) based on availability and/or contraindications, for moderate NMB reversal.
|
|
|
| OG001 |
| Part A: Sugammadex 4 mg/kg |
Participants received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal. |
| OG002 | Part B: Sugammadex 2 mg/kg | Participants received a single IV bolus of sugammadex at 2 mg/kg for moderate NMB reversal. |
| OG003 | Part B: Sugammadex 4 mg/kg | Participants received a single IV bolus of sugammadex at 4 mg/kg for deep NMB reversal. |
| OG004 | Part B: Neostigmine + (Glycopyrrolate or Atropine) | Participants received a single IV bolus containing neostigmine (50 μg/kg; up to 5 mg maximum dose) in combination with either glycopyrrolate (10 μg/kg) or atropine sulfate (20 μg/kg) based on availability and/or contraindications, for moderate NMB reversal. |
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