Sugammadex

Generic Name: Sugammadex

Brand Names: Bridion, Sugammadex Adroiq, Sugammadex Amomed, Sugammadex Fresenius Kabi, Sugammadex Mylan, Sugammadex Piramal

Drug Type: Small Molecule

Chemical Formula: C_₇₂H_₁₁₂O_₄₈S_₈

CAS Number: 343306-71-8

Unique Ingredient Identifier: 361LPM2T56

Background: Sugammadex is a selective relaxant binding agent indicated for reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide during surgery. Rocuronium bromide and vecuronium bromide are neuromuscular blocking medications that cause temporary paralysis and are especially useful for general anesthesia, ventilation, or tracheal intubation that patients may require for surgery. Sugammadex provides a new treatment option to reverse the effects of those medications and possibly help patients recover sooner post-surgery. Sugammadex (brand name Bridion) is marketed by Merck Sharp and Dohme, and was approved by the United States FDA on December 15, 2015.

Indication: Sugammadex is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide or vecuronium bromide in adults and pediatric patients ≥2 years old who are undergoing surgery.

Associated Conditions: Neuromuscular blockade caused by vecuronium bromide

Clinical Trials

Optimal Relaxation Technique for Laparotomies With Rocuronium Infusion Followed by Sugammadex Reversal

Phase 4

Completed

Conditions: Underdosing of Skeletal Muscle Relaxants for Laparotomy
Reversal of Skeletal Muscle Relaxant

Interventions: Drug: Neostigmine, atropine
Drug: Sugammadex

First Posted Date: 2012-02-27

Last Posted Date: 2015-08-07

Lead Sponsor: Hospital Sultanah Aminah Johor Bahru

Target Recruit Count: 49

Registration Number: NCT01539044

Locations: 🇲🇾
Hospital Sulatanah Aminah, Johor Bahru, Johor, Malaysia

Sugammadex and Heart Failure

Phase 3

Completed

Conditions: Postoperative Neuromuscular Block

Interventions: Drug: Sugammadex

First Posted Date: 2012-01-13

Last Posted Date: 2012-04-04

Lead Sponsor: Onze Lieve Vrouw Hospital

Target Recruit Count: 12

Registration Number: NCT01509651

Locations: 🇧🇪
OLV Hospital, Aalst, Belgium

Evaluation of Accelerometer-Based Neuromuscular Monitoring Reliability to Exclude Postoperative Residual Paralysis

Not Applicable

Completed

Conditions: Postoperative Residual Paralysis

Interventions: Drug: sugammadex
Drug: Sodium chloride solution

First Posted Date: 2012-01-04

Last Posted Date: 2014-04-22

Lead Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Target Recruit Count: 20

Registration Number: NCT01503840

Locations: 🇮🇹
Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy

Study of Sugammadex Versus Usual Care on Incidence of Residual Blockade at Post Anesthesia Care Unit Admission (P07981)

Phase 3

Completed

Conditions: Surgical Procedures, Elective

Interventions: Drug: Sugammadex
Drug: Neostigmine
Drug: Glycopyrrolate

First Posted Date: 2011-11-24

Last Posted Date: 2017-06-06

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 154

Registration Number: NCT01479764

Street Fitness in Surgical Patients Undergoing General Anesthesia After Reversal of Neuromuscular Blockade

Phase 4

Conditions: Anesthesia Recovery Period

Interventions: Drug: Neostigmine/Glycopyrrolate
Other: Placebo
Drug: Sugammadex

First Posted Date: 2011-10-18

Last Posted Date: 2011-10-18

Lead Sponsor: Radboud University Medical Center

Target Recruit Count: 30

Registration Number: NCT01453530

Locations: 🇳🇱
UMC Sint Radboud, Nijmegen, Gelderland, Netherlands

Sugammadex Efficacy and Safety for Reversal of Pipecuronium-induced Neuromuscular Blockade

Phase 4

Conditions: Adult Subjects Undergoing Abdominal Surgery Under General Anesthesia

Interventions: Drug: placebo
Drug: sugammadex

First Posted Date: 2011-08-29

Last Posted Date: 2011-08-29

Lead Sponsor: Central Clinical Hospital #1 of LLC Russian Railways

Target Recruit Count: 42

Registration Number: NCT01424488

Locations: 🇷🇺
Central Clinical Hospital #1 of LLC "Russian Railroad", Moscow, Russian Federation

Reversal of Neuromuscular Blockade With Sugammadex or Usual Care in Hip Fracture Surgery or Joint (Hip/Knee) Replacement (P07038)

Phase 3

Completed

Conditions: Neuromuscular Blockade
Arthroplasty, Replacement, Hip
Arthroplasty, Replacement, Knee
Blood Coagulation
Antithrombotic Agents

Interventions: Drug: Sugammadex
Drug: neostigmine and glycopyrrolate or atropine
Drug: Placebo to sugammadex
Drug: Placebo to neostigmine

First Posted Date: 2011-08-23

Last Posted Date: 2021-02-12

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 1198

Registration Number: NCT01422304

Sugammadex: Effect on the Awareness Monitoring and Hemodynamics

Not Applicable

Conditions: Surgical Procedure, Unspecified

Interventions: Drug: Sugammadex 4 mg/kg
Drug: Sugammadex 16mg/kg
Drug: sugammadex

First Posted Date: 2011-02-23

Last Posted Date: 2012-06-19

Lead Sponsor: University of Athens

Target Recruit Count: 60

Registration Number: NCT01301261

Locations: 🇬🇷
Department of Anesthesiology, Aretaieio Hospital, Athens, Greece

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)

Completed

Conditions: Neuromuscular Monitoring After Administration of Neuromuscular Blocking Agents in Different Types of Surgery

Interventions: Other: No neuromuscular blockade (NMB)-reversal agent used
Drug: Other NMB-Reversal Agents Used in Routine Anesthesiology Practice
Drug: Sugammadex

First Posted Date: 2010-10-01

Last Posted Date: 2015-03-17

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 659

Registration Number: NCT01213264

Recovery Effect of Sugammadex Measured by Bispectral and Neurosense Indices

Phase 4

Completed

Conditions: Anesthesia

Interventions: Drug: Sugammadex - Nacl 9/00
Drug: Nacl 9/00 - sugammadex

First Posted Date: 2010-07-13

Last Posted Date: 2017-05-24

Lead Sponsor: Hopital Foch

Target Recruit Count: 50

Registration Number: NCT01161004

Locations: 🇫🇷
Hopital Foch, Suresnes, France

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