Clinical trials: Reversal of Neuromuscular Blockade
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
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
Reversing Vecuronium-Induced Neuromuscular Blockade in Patients Undergoing General Anesthesia Surgery, Reversing Rocuronium-Induced Neuromuscular Blockade in Patients Undergoing General Anesthesia Surgery
A Dose-Finding Study of Amogammadex Sodium for Reversing Vecuronium and Rocuronium-Induced Neuromuscular Blockade
Background context: Amogammadex sodium has completed Phase I-III clinical studies in China for reversal of rocuronium-induced blockade. No clinical studies have yet been conducted for vecuronium-induced blockade.
- Trial name
- NCT07595393
- Testing
- Rocuronium (0.6mg/kg), vecuronium bromide (0.1mg/kg)
- Volunteers
- 64 people
- Sponsor
- Amckaus PTY LTD.
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.
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
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
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
Comparison of Sugammadex (MK-8616/Org 25969) With Neostigmine Administered at 1-2 Post-tetanic Counts (PTCs) After Administration of Rocuronium or Vecuronium (19.4.302/P05945/MK-8616-025)
The purpose of the trial is to demonstrate a faster recovery from neuromuscular block (NMB) induced with rocuronium or vecuronium after reversal by 4.0 mg/kg of Org 25969 compared with reversal by 70 μg/kg of neostigmine in…
- Trial name
- NCT00473694
- Testing
- sugammadex, neostigmine, vecuronium
- Volunteers
- 182 people
- Sponsor
- Merck Sharp & Dohme LLC
Reversal of Neuromuscular Blockade
A Single Ascending Dose of HRS-2162 in Healthy Subjects
The study is being conducted to evaluate the safety and tolerability of HRS-2162 injection in a single dose in healthy subjects, as well as the characteristics of PK/PD
- Trial name
- NCT07195604
- Testing
- HRS-2162
- Where
- China
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
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
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
Surgical Procedures, Elective
Study of Sugammadex Versus Usual Care on Incidence of Residual Blockade at Post Anesthesia Care Unit Admission (P07981)
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…
- Trial name
- NCT01479764
- Testing
- Sugammadex, Neostigmine, Glycopyrrolate
- Volunteers
- 154 people
- Sponsor
- Merck Sharp & Dohme LLC
Reversal of Neuromuscular Blockade
Evaluation of the Clinical Efficacy and Safety of BriTurn Injection or BrisTurn Prefilled Injection
This study evaluate clinical efficacy and safety in adult patients administered BriTurn injection or BrisTurn Prefilled injection for reversal of neuromuscular blockade induced by Rocuronium or Vecuronium.
- Trial name
- NCT06246331
- Where
- South Korea
- Volunteers
- 1,500 people
- Sponsor
- Hanlim Pharm. Co., Ltd.
Anesthesia
Comparison of Sugammadex Administered at 1-2 Post Tetanic Counts (PTCs) or Better With Neostigmine Administered as Per Standard of Care to Reverse Rocuronium-Induced Neuromuscular Blockade in Adults Undergoing Elective Open Abdominal Procedure (19.4.334) (P05774)
The primary purpose of this study is to compare the incidence of residual neuromuscular blockade at the time of tracheal extubation after reversal of rocuronium bromide-induced neuromuscular blockade by 4 mg/kg sugammadex with…
- Trial name
- NCT00675792
- Testing
- Sugammadex, Neostigmine, Rocuronium
- Volunteers
- 100 people
- Sponsor
- Merck Sharp & Dohme LLC