Clinical trials: Sugammadex
Neuromuscular Blockade, Arthroplasty, Replacement, Hip
Reversal of Neuromuscular Blockade With Sugammadex or Usual Care in Hip Fracture Surgery or Joint (Hip/Knee) Replacement (P07038)
This study will assess the effect of reversal of neuromuscular blockade with sugammadex compared with reversal according to usual care (neostigmine or spontaneous reversal) on the incidence of post-surgical bleeding events and on…
- Conditions
- Neuromuscular Blockade, Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee, Blood Coagulation
- Trial name
- NCT01422304
- Testing
- Sugammadex, neostigmine and glycopyrrolate or atropine
- Volunteers
- 1,198 people
- Sponsor
- Merck Sharp & Dohme LLC
Anesthesia, General
Comparison of Sugammadex (Org 25969) With Neostigmine as Reversal Agents for Rocuronium or Vecuronium at Reappearance of T2 (P05960)
The purpose of this study was to demonstrate in adult participants faster recovery from a neuromuscular block induced by either rocuronium or vecuronium after reversal at reappearance of T2 (the amplitude of the first response of…
- Trial name
- NCT00451217
- Testing
- Sugammadex, Neostigmine
- Volunteers
- 198 people
- Sponsor
- Merck Sharp & Dohme LLC
Anesthesia, General
Sugammadex After Continuous Infusion of Rocuronium During Sevoflurane and Propofol Anesthesia (P05949; MK-8616-028)
The objective of the trial was to show equivalence in recovery from neuromuscular block after a single dose of 4.0 mg/kg sugammadex, administered at first twitch (T1) 3-10% after continuous infusion of rocuronium, between…
- Trial name
- NCT00559468
- Testing
- Sugammadex, Rocuronium, Sevoflurane
- Volunteers
- 52 people
- Sponsor
- Merck Sharp & Dohme LLC
Neuromuscular Blockade
Efficacy and Safety of Sugammadex Dosed According to Actual Body Weight (ABW) or Ideal Body Weight (IBW) in Reversal of Neuromuscular Blockade (NMB) in Morbidly Obese Participants (MK-8616-146)
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…
- Trial name
- NCT03346070
- Testing
- Sugammadex 2 mg/kg ABW, Sugammadex 2 mg/kg IBW, Sugammadex 4 mg/kg ABW
- Where
- 24 sites in United States, Austria and 3 more
- Volunteers
- 207 people
- Sponsor
- Merck Sharp & Dohme LLC
Underdosing of Other General Anesthetics
Influence of Mild Hypothermia on Reversal of Rocuronium With Sugammadex
The primary efficacy endpoint is the time from the start of administration of sugammadex to recovery of the TOF ratio to 0.9 in deep neuromuscular block (1-2 twitches post-tetanic count) induced by rocuronium during mild…
- Trial name
- NCT01965067
- Testing
- sugammadex
- Where
- South Korea
- Volunteers
- 60 people
- Sponsor
- MSD Korea Ltd.
Anesthesia, General
A Bridging Trial Comparing Sugammadex (Org 25969) at Reappearance of T2 in Japanese and Caucasian Participants. Part A: Japanese Participants (P05956)
The objective of this trial was to establish the dose-response of T2 (the amplitude of the first response of second twitch to train of four (TOF) stimulation, expressed as percentage of control first twitch,T1) in Japanese and…
- Trial name
- NCT00591409
- Testing
- sugammadex
- Volunteers
- 100 people
- Sponsor
- Merck Sharp & Dohme LLC
Hypersensitivity
Sugammadex Hypersensitivity Study (Study P06042)
This trial was conducted to study the potential for hypersensitivity symptoms at the time of initial exposure to sugammadex and upon repeat exposure, since it was unknown whether the frequency or severity of hypersensitivity…
- Trial name
- NCT00988065
- Testing
- Sugammadex 4 mg/kg, Sugammadex 16 mg/kg
- Volunteers
- 448 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Anesthesia, General
Comparison of Recovery From Rocuronium 1.2 mg/kg Followed by Sugammadex (Org 25969) 16 mg/kg at 3 Minutes With Recovery From Succinylcholine 1.0 mg/kg (19.4.303)(P05946)(MK-8616-026)
The purpose of the trial is to demonstrate a faster recovery from neuromuscular block induced by 1.2 mg/kg rocuronium after reversal at 3 minutes by 16.0 mg/kg of sugammadex compared with recovery after a neuromuscular block…
- Trial name
- NCT00474253
- Testing
- Sugammadex, Succinylcholine, Rocuronium
- Volunteers
- 115 people
- Sponsor
- Merck Sharp & Dohme LLC
Neuromuscular Blockade
Efficacy and Safety of Org 25969 Administered After Zemuron® (MK-8616-042)
The primary objective of this study is to explore the dose-response relation of MK-8616 (Org 25969) given as a reversal agent of Zemuron® at 1 to 2 post tetanic counts (PTCs); both Zemuron® and MK-8616 are administered by…
- Trial name
- NCT03519867
- Testing
- MK-8616, Zemuron®
- Volunteers
- 50 people
- Sponsor
- Merck Sharp & Dohme LLC
Anesthesia, General
A Bridging Trial Comparing Sugammadex (Org 25969) at Reappearance of T2 in Japanese and Caucasian Participants. Part B: Caucasian Participants (P05971)
The objective of the trial was to establish the dose-response relation of sugammadex (Org 25969) given as a reversal agent of rocuronium or vecuronium at reappearance of T2 (the amplitude of the first response of second twitch to…
- Trial name
- NCT00552617
- Testing
- Sugammadex, Rocuronium, Vecuronium
- Volunteers
- 100 people
- Sponsor
- Merck Sharp & Dohme LLC
Intubating Conditions, Postoperative Myalgia
Comparing Intubating Conditions Using Succinylcholine or Rocuronium for Rigid Bronchoscopy
Succinylcholine is commonly used for neuromuscular relaxation for short procedures such as rigid bronchoscopy. A more modern alternative is the application aof rocuronium, reversed by sugammadex.
- Conditions
- Intubating Conditions, Postoperative Myalgia, Patient Satisfaction
- Trial name
- NCT01996358
- Testing
- Succinylcholine, Rocuronium 0,3, Rocuronium 0,6
- Where
- Germany
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Dr. Horst Schmidt Klinik GmbH
Anesthesia, General, Neuromuscular Blockade
Comparison of 2.0 mg/kg Sugammadex and Neostigmine at Reappearance of T2 in Chinese and European Subjects (Study 19.4.324)(P05768AM1)(COMPLETED)
The present trial was set up to evaluate the efficacy and safety of 2.0 mg.kg-1 sugammadex compared to neostigmine administered at reappearance of T2 in Chinese and Caucasian subjects for registration purposes in China.
- Trial name
- NCT00825812
- Testing
- Sugammadex, neostigmine
- Volunteers
- 308 people
- Sponsor
- Merck Sharp & Dohme LLC
Neuromuscular Blockade
Relation Between TOF-Watch® SX and a Peripheral Nerve Stimulator After 4.0 mg.Kg-1 Sugammadex (P05698)
The objective of the trial is to determine the relationship within a participant between the time to manual detection of the reappearance of the fourth twitch (T4) measured using a peripheral nerve stimulator (PNS) and the time…
- Trial name
- NCT00535496
- Testing
- sugammadex
- Volunteers
- 91 people
- Sponsor
- Merck Sharp & Dohme LLC
Neuromuscular Blockade
Dialysis of Sugammadex in Participants With Severe Renal Impairment (Study 19.4.333) (P05773)
The clinical trial objectives were to evaluate the dialysability of the sugammadex-rocuronium complex; it's safety and efficacy in participants with severe renal impairment.
- Trial name
- NCT00656799
- Testing
- sugammadex, Rocuronium
- Volunteers
- 6 people
- Sponsor
- Merck Sharp & Dohme LLC
Neuromuscular Blockade
Efficacy, Safety, and Pharmacokinetics of Sugammadex (MK-8616) for Reversal of Neuromuscular Blockade in Pediatric Participants Aged Birth to <2 Years (MK-8616-169)
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.
- Trial name
- NCT03909165
- Testing
- Sugammadex 2 mg/kg, Sugammadex 4 mg/kg, Neostigmine + Glycopyrrolate
- Where
- 39 sites in United States, Australia and 12 more
- Volunteers
- 145 people
- Sponsor
- Merck Sharp & Dohme LLC
Anesthesia, Neuromuscular Blockade
Comparing 4.0 mg.Kg-1 Sugammadex With Placebo in the Reversal of Profound Neuromuscular Blockade (P05767)
The current trial was designed to demonstrate faster recovery in participants undergoing elective surgeries requiring profound neuromuscular blockade induced by rocuronium to a fourth twitch/first twitch (T4/T1) ratio of 0.9…
- Trial name
- NCT00758485
- Testing
- Sugammadex, 0.9% sodium chloride (NaCl)
- Volunteers
- 140 people
- Sponsor
- Merck Sharp & Dohme LLC
Anesthesia
Dose-Finding Pediatric and Adult Trial With Sugammadex (Org 25969, MK-8616, SCH 900616) (19.4.306) (MK-8616-034) (P05961)
The purpose of this study is: to explore the dose-response relation of sugammadex (Org 25969, MK-8616, SCH 900616) given as a reversal agent at reappearance of T2 after 0.6 mg.kg-1 rocuronium in pediatric and adult participants…
- Trial name
- NCT00421148
- Testing
- Sugammadex 0.5 mg/kg, Sugammadex 1 mg/kg, Sugammadex 2 mg/kg
- Volunteers
- 94 people
- Sponsor
- Merck Sharp & Dohme LLC
Anesthesia, General
Use of Sugammadex at the End of Case in Routine Anesthesia (MK-8616-023)
The primary purpose of the study is to determine the time-course of recovery to a T4/T1 ratio of 0.9 within 4 minutes after 4.0 mg.kg^-1 Sugammadex is administered at least 15 minutes after the last administration of rocuronium…
- Trial name
- NCT00298831
- Testing
- Sugammadex, Rocuronium
- Volunteers
- 224 people
- Sponsor
- Merck Sharp & Dohme LLC
Neuromuscular Blockade
Efficacy, Safety, and Pharmacokinetics of Sugammadex for Reversal of Neuromuscular Blockade (NMB) in Pediatric Participants (MK-8616-089)
This trial will evaluate the efficacy, safety, and pharmacokinetics of sugammadex for the reversal of both moderate and deep neuromuscular blockade (NMB) induced by either rocuronium or vecuronium in pediatric participants.
- Trial name
- NCT03351608
- Testing
- Sugammadex 2 mg/kg, Sugammadex 4 mg/kg, Neostigmine + Glycopyrrolate
- Where
- 30 sites in United States, Austria and 6 more
- Volunteers
- 288 people
- Sponsor
- Merck Sharp & Dohme LLC
Neuromuscular Monitoring After Administration of Neuromuscular Blocking Agents in Different Types of Surgery
Observational Study to Evaluate the Current Neuromuscular Monitoring Practice Used After Different Types of Surgery, for Which Neuromuscular Blocking Agents Were Used, With or Without Blocking Reversal (P06556)
The intent of this observational study is to collect prospective data regarding neuromuscular monitoring practices and extubation standards (Train-Of-Four [TOF] value) during surgery, in countries of Central and Eastern Europe…
- Trial name
- NCT01213264
- Testing
- No neuromuscular blockade (NMB)-reversal agent used, Sugammadex, Other NMB-Reversal Agents Used in Routine Anesthesiology Practice
- Volunteers
- 659 people
- Sponsor
- Merck Sharp & Dohme LLC