Clinical trials: Rocuronium
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, 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
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
Neuromuscular Blockade
Efficacy, Safety and Pharmacokinetics of Sugammadex (Org 25969; MK-8616) at 3 Different Time Points After 0.6 mg/kg Esmeron® in Male Participants (P05940; MK-8616-020).
This study investigates the efficacy, safety, and pharmacokinetics of sugammadex (Org 25969; MK-8616) when administered for the reversal of neuromuscular blockade in male participants receiving surgery, classified as American…
- Trial name
- NCT03519854
- Testing
- Sugammadex, Esmeron®
- Volunteers
- 99 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, 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
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
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
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
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
Anesthesia, General
Dose-Finding Trial With Sugammadex Administered at 3 and 15 Minutes After 1.0 and 1.2 mg/kg Rocuronium Bromide in Participants of ASA Class 1-3 (P05944; MK-8616-024)
The objective of this trial was to explore the dose-response relation of sugammadex (Org 25969; MK-8616) administered for the reversal of neuromuscular blockade (NMB) at 3 and 15 minutes following administration of 1.0 and 1.2…
- Trial name
- NCT00535743
- Testing
- Sugammadex, Esmeron®
- Volunteers
- 174 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
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
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
Anesthesia
A Study to Determine the Dose Requirements of Rocuronium Bromide (Zemuron®) in Pediatric and Adolescent Subjects (21048)(COMPLETED)(P05797)
The primary purpose of this study is to determine the dose requirements of rocuronium bromide when administered as a bolus dose (a single, large dose) for intubation (insertion of a tube through the nose or mouth into the trachea…
- Trial name
- NCT00124735
- Testing
- Rocuronium bolus maintenance, rocuronium continuous infusion maintenance
- Volunteers
- 149 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, Neuromuscular Blockade
The Effect of Neuromuscular Blockade on the Composite Variability Index (CVI) During Laryngoscopy
The Bispectral Index (BIS) monitor is used in many operating rooms to provide information to the anesthesiologist about a patient's level of consciousness.
- Trial name
- NCT01450813
- Testing
- Saline 0.06 ml/kg, Rocuronium 0.2 mg/kg, Rocuronium 0.4 mg/kg
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Medtronic - MITG
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
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
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