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| ID | Type | Description | Link |
|---|---|---|---|
| MK-8616-064 | Other Identifier | Merck study number |
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This study will compare the incidence of residual neuromuscular blockade in participants who undergo reversal of neuromuscular blockade with sugammadex compared to those who undergo reversal of neuromuscular blockade with usual care (neostigmine/glycopyrrolate).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sugammadex | Experimental | Participants receive sugammadex, 2 or 4 mg/kg, depending on level of neuromuscular recovery |
|
| Neostigmine/glycopyrrolate | Active Comparator | Participants receive neostigmine/glycopyrrolate per usual practice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sugammadex | Drug | sugammadex, intravenous (IV) bolus, 2 or 4 mg/kg depending on level of neuromuscular recovery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Residual Neuromuscular Blockade (NMB) as Defined by a Train-of-Four (TOF) Ratio <0.9 at Post Anesthesia Care Unit (PACU) Entry | Neuromuscular functioning was monitored by applying four TOF electrical stimulations to the ulnar nerve and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB, with a higher ratio indicating greater recovery from NMB. A T4/T1 Ratio of <0.9 is indicative of residual NMB. | At PACU entry on Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Time From Start of Study Drug Administration to Operating Room Discharge-ready | The time of operating room discharge readiness was determined by the surgical team based on clinical evaluations. | Day 1 |
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Inclusion Criteria:
American Society of Anesthesiologists (ASA) Class 1 or 2 or 3
Scheduled to undergo an elective abdominal surgical procedure under general anesthesia; and:
endotracheal intubation; and
expected to require at least one maintenance dose of rocuronium; and
expected to require active reversal of neuromuscular blockade; and
expected to require clinical or subjective neuromuscular monitoring only; and
expected to recover in the PACU
medically accepted method of contraception through seven days after receiving
protocol-specified medication.
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25935840 | Result | Brueckmann B, Sasaki N, Grobara P, Li MK, Woo T, de Bie J, Maktabi M, Lee J, Kwo J, Pino R, Sabouri AS, McGovern F, Staehr-Rye AK, Eikermann M. Effects of sugammadex on incidence of postoperative residual neuromuscular blockade: a randomized, controlled study. Br J Anaesth. 2015 Nov;115(5):743-51. doi: 10.1093/bja/aev104. Epub 2015 May 2. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sugammadex | Participants receive a single intravenous (IV) bolus dose of sugammadex, 2 or 4 mg/kg, depending on level of neuromuscular recovery |
| FG001 | Neostigmine/Glycopyrrolate | Participants receive a single IV bolus dose of neostigmine/glycopyrrolate (neostigmine total dose not to exceed 5 mg) per usual practice |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Randomized |
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| |||||||||||||||||||||
| Treated |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sugammadex | Participants receive a single intravenous (IV) bolus dose of sugammadex, 2 or 4 mg/kg, depending on level of neuromuscular recovery |
| BG001 | Neostigmine/Glycopyrrolate |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Incidence of Residual Neuromuscular Blockade (NMB) as Defined by a Train-of-Four (TOF) Ratio <0.9 at Post Anesthesia Care Unit (PACU) Entry | Neuromuscular functioning was monitored by applying four TOF electrical stimulations to the ulnar nerve and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB, with a higher ratio indicating greater recovery from NMB. A T4/T1 Ratio of <0.9 is indicative of residual NMB. | The analysis population consisted of all randomized participants who received at least one dose of study drug (sugammadex or neostigmine/glycopyrrolate) and had a reliable TOF measurement at PACU entry. | Posted | Number | participants | At PACU entry on Day 1 |
|
Up to 7 days after administration of study drug
Treatment emergent adverse events in the All Patients as Treated population which consisted of all randomized participants who received at least one dose of study drug (sugammadex or neostigmine/glycopyrrolate).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sugammadex | Participants receive a single intravenous (IV) bolus dose of sugammadex, 2 or 4 mg/kg, depending on level of neuromuscular recovery |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Late Stage Development Group Leader | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D000077122 | Sugammadex |
| D009388 | Neostigmine |
| D006024 | Glycopyrrolate |
| ID | Term |
|---|---|
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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| Neostigmine | Drug | neostigmine, per usual practice |
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| Glycopyrrolate | Drug | glycopyrrolate per usual practice |
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| NOT COMPLETED |
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Participants receive a single IV bolus dose of neostigmine/glycopyrrolate (neostigmine total dose not to exceed 5 mg) per usual practice
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Participants receive a single intravenous (IV) bolus dose of sugammadex, 2 or 4 mg/kg, depending on level of neuromuscular recovery
| OG001 | Neostigmine/Glycopyrrolate | Participants receive a single IV bolus dose of neostigmine/glycopyrrolate (neostigmine total dose not to exceed 5 mg) per usual practice |
|
|
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| Secondary | Time From Start of Study Drug Administration to Operating Room Discharge-ready | The time of operating room discharge readiness was determined by the surgical team based on clinical evaluations. | The analysis population consisted of all randomized participants who received at least one dose of study drug (sugammadex or neostigmine/glycopyrrolate). | Posted | Least Squares Mean | 95% Confidence Interval | minutes | Day 1 |
|
|
|
|
| 7 |
| 74 |
| 18 |
| 74 |
| EG001 | Neostigmine/Glycopyrrolate | Participants receive a single IV bolus dose of neostigmine/glycopyrrolate (neostigmine total dose not to exceed 5 mg) per usual practice | 8 | 77 | 18 | 77 |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Gastronintestinal haemorrhage | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Ileus paralytic | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 15.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Wound infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Delayed recovery from anaesthesia | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
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| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
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| Post procedural myocardial infarction | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
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| Procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
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| Delirium | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
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| Haemorrhage | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 15.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
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The investigator agrees to provide to the Sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication and slides and texts of oral or other presentations that report any results of the trial.
| 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 |