Clinical trials: Muscle Relaxation
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 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
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 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
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
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
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
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, 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, 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
Gallbladder Disease
A Study Comparing the Use of Deep or Standard Neuromuscular Blockade in Combination With Low or Standard Insufflation Pressures in Participants Undergoing Laparoscopic Cholecystectomy (P07982)
The purpose of this pilot study is to compare the use of deep or standard neuromuscular blockade (NMB) in combination with low or standard insufflation pressure in participants undergoing a surgical procedure, laparoscopic…
- Trial name
- NCT01728584
- Testing
- Rocuronium, Insufflation, Sugammadex
- Where
- 2 sites in Germany, Italy
- Volunteers
- 127 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
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
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
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
Neuromuscular Blockade
Incidence of Incomplete Postoperative Neuromuscular Recovery From Anesthesia (P07535)(Completed)
This is a multicenter, observational study in adult participants undergoing different types of elective surgical procedures requiring general anesthesia.
- Trial name
- INSPIRE (NCT01181349)
- Testing
- Neuromuscular Blocking Agent (NMBA)
- Volunteers
- 350 people
- Sponsor
- Merck Sharp & Dohme LLC
Neuromuscular Blockade
Rocuronium Plus Sugammadex Versus Succinylcholine Alone in Participants Undergoing Short Surgical Procedures (19.4.319)(P05700 AM2)(COMPLETED)
A multi-center, randomized, parallel group, comparative, active controlled, safety assessor blinded trial in adult subjects comparing rocuronium plus sugammadex versus succinylcholine alone in subjects undergoing short surgical…
- Trial name
- NCT00751179
- Testing
- rocuronium, sugammadex, succinylcholine
- Volunteers
- 161 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC