Clinical trials: Sugammadex
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
Anesthesia, General
Comparison of Sugammadex With Neostigmine During Laparoscopic Cholecystectomy or Appendectomy (P05699)
The current trial was designed to demonstrate faster recovery from a neuromuscular blockade (NMB) induced by rocuronium after reversal at 1-2 Post Tetanic Count (PTC) by 4.0 mg.kg-1 sugammadex compared to 50 µg.kg-1 neostigmine…
- Trial name
- NCT00724932
- Testing
- Rocuronium, Sugammadex, Neostigmine
- Volunteers
- 140 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 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
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
Neuromuscular Blockade
Comparison of Sugammadex With Neostigmine as Reversal Agents for Rocuronium at Reappearance of T2 (Study P06101)
This is a randomized, active-controlled, parallel-group, single-dose, multi-site, safety-assessor blinded study comparing sugammadex to neostigmine for reversal of neuromuscular blockade in Korean subjects undergoing elective…
- Trial name
- DANCHEONG (NCT01050543)
- Testing
- sugammadex, neostigmine
- Volunteers
- 128 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
Hypersensitivity, Anaphylaxis
A Study to Evaluate the Incidence of Hypersensitivity After Administration of Sugammadex in Healthy Participants (MK-8616-101)
The purpose of this study is to assess the potential for hypersensitivity symptoms upon repeat exposure to sugammadex. Healthy participants will be randomized to one of three treatment arms: sugammadex 4 mg/kg, sugammadex 16…
- Trial name
- NCT02028065
- Testing
- Sugammadex
- Volunteers
- 382 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
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
Anesthesia, General
A Bridging Trial Comparing Sugammadex (Org 25969) at 1-2 Post-Tetanic Count (PTC) in Japanese Participants. Part A (P05957)
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 1-2 PTC during sevoflurane anesthesia for Japanese participants.
- Trial name
- NCT00591786
- Testing
- Sugammadex
- Volunteers
- 100 people
- Sponsor
- Merck Sharp & Dohme LLC
Anesthesia, General
Comparison of the Efficacy, Safety, and Pharmacokinetics of Sugammadex (MK-8616; Org 25969) in Elderly Participants With Adult Participants (MK-8616-029)
The purpose of the study is to compare the effectiveness, safety and pharmacokinetics of sugammadex in participants 65 and over with participants under 65. There is no hypothesis defined for the study.
- Trial name
- NCT00474617
- Testing
- Sugammadex, Rocurium
- Volunteers
- 162 people
- Sponsor
- Merck Sharp & Dohme LLC
Reversal of Neuromuscular Blockade
Safety of Sugammadex for the Reversal of Neuromuscular Blockade in American Society of Anesthesiologists (ASA) Class 3 or 4 Participants (MK-8616-145)
The purpose of this trial is to evaluate the safety of sugammadex for the reversal of neuromuscular blockade (NMB) induced by neuromuscular blockade agents (NMBA) rocuronium or vecuronium in adult American Society of…
- Trial name
- NCT03346057
- Testing
- Sugammadex 2 mg/kg, Sugammadex 4 mg/kg, Sugammadex 16 mg/kg
- Where
- 30 sites in United States, Austria and 2 more
- Volunteers
- 344 people
- Sponsor
- Merck Sharp & Dohme LLC
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, 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, Neuromuscular Blockade
Efficacy and Safety of 4.0 mg/kg Sugammadex at 1-2 PTC in Chinese and European Subjects (Study 19.4.335)(P05775AM1)(COMPLETED)
The present trial is set up to evaluate the efficacy and safety of 4.0 mg.kg-1 sugammadex in Chinese and Caucasian subjects for registration purposes in China.
- Trial name
- NCT00826176
- Testing
- Sugammadex
- Volunteers
- 164 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
Anesthesia, General
Safety and Efficacy of Sugammadex (Org 25969, MK-8616) in Participants With or Having a Past History of Pulmonary Disease (19.4.308) (P05932) (MK-8616-017)
The purpose of the trial is to research the safety and to show faster recovery after administration of 2.0 mg/kg or 4.0 mg/kg sugammadex (Org 25969, MK-8616) given as a reversal agent for 0.6 mg/kg (0.15 mg/kg maintenance dose)…
- Trial name
- NCT00475215
- Testing
- Sugammadex, Rocuronium
- Volunteers
- 86 people
- Sponsor
- Merck Sharp & Dohme LLC
Anesthesia, General
A Bridging Trial Comparing Sugammadex (Org 25969) at 1-2 Post-Tetanic Count (PTC) in Caucasian Participants. Part B (P05974)
The objective of the trial was to establish the dose-response relation of sugammadex given as a reversal agent of rocuronium or vecuronium at 1-2 Post-Tetanic Count (PTC) during sevoflurane anesthesia for Caucasian participants
- Trial name
- NCT00552929
- Testing
- Sugammadex
- Volunteers
- 102 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