DeepMed Research

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

Sugammadex and Brain Waves

Phase 4

Completed

Conditions: Anaesthesia

First Posted Date: 2010-06-11

Last Posted Date: 2010-06-11

Lead Sponsor: Tampere University Hospital

Target Recruit Count: 30

Registration Number: NCT01142648

Locations: 🇫🇮
Tampere University Hospital, Tampere, Finland

Sugammadex Improves Muscle Function After Standard Neuromuscular Recovery

Phase 4

Completed

Conditions: Neuromuscular Blockade

Interventions: Drug: Placebo
Drug: Sugammadex

First Posted Date: 2010-04-09

Last Posted Date: 2012-12-17

Lead Sponsor: Technical University of Munich

Target Recruit Count: 300

Registration Number: NCT01101139

Locations: 🇩🇪
Klinik für Anaesthesiologie Klinikum München rechts der Isar, Munic, Bavaria, Germany

Comparison of Sugammadex With Neostigmine as Reversal Agents for Rocuronium at Reappearance of T2 (Study P06101)

Phase 3

Completed

Conditions: Neuromuscular Blockade

Interventions: Drug: neostigmine
Drug: sugammadex

First Posted Date: 2010-01-15

Last Posted Date: 2017-07-02

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 128

Registration Number: NCT01050543

Sugammadex and Neostigmine at Residual Neuromuscular Blockade

Completed

Conditions: Residual Neuromuscular Block (TOF-ratio of 0.2)

Interventions: Drug: Neostigmine
Drug: Sugammadex
Drug: Saline

First Posted Date: 2009-11-03

Last Posted Date: 2012-12-13

Lead Sponsor: Technical University of Munich

Target Recruit Count: 99

Registration Number: NCT01006720

Locations: 🇩🇪
Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München, Munic, Bavaria, Germany

Sugammadex Hypersensitivity Study (Study P06042)

Phase 1

Completed

Conditions: Hypersensitivity

Interventions: Drug: Placebo run-in dose
Drug: Placebo
Drug: Sugammadex 4 mg/kg
Drug: Sugammadex 16 mg/kg

First Posted Date: 2009-10-01

Last Posted Date: 2019-01-30

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 448

Registration Number: NCT00988065

Efficacy and Safety of 4.0 mg/kg Sugammadex at 1-2 PTC in Chinese and European Subjects (Study 19.4.335)(P05775AM1)(COMPLETED)

Phase 3

Completed

Conditions: Anesthesia, General
Neuromuscular Blockade

Interventions: Drug: Sugammadex

First Posted Date: 2009-01-21

Last Posted Date: 2015-10-07

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 164

Registration Number: NCT00826176

Comparison of 2.0 mg/kg Sugammadex and Neostigmine at Reappearance of T2 in Chinese and European Subjects (Study 19.4.324)(P05768AM1)(COMPLETED)

Phase 3

Completed

Conditions: Anesthesia, General
Neuromuscular Blockade

Interventions: Drug: Sugammadex
Drug: neostigmine

First Posted Date: 2009-01-21

Last Posted Date: 2015-11-01

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 308

Registration Number: NCT00825812

Comparing 4.0 mg.Kg-1 Sugammadex With Placebo in the Reversal of Profound Neuromuscular Blockade (P05767)

Phase 3

Completed

Conditions: Anesthesia
Neuromuscular Blockade

Interventions: Drug: 0.9% sodium chloride (NaCl)
Drug: Sugammadex

First Posted Date: 2008-09-25

Last Posted Date: 2015-08-21

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 140

Registration Number: NCT00758485

Rocuronium Plus Sugammadex Versus Succinylcholine Alone in Participants Undergoing Short Surgical Procedures (19.4.319)(P05700 AM2)(COMPLETED)

Phase 3

Completed

Conditions: Neuromuscular Blockade

Interventions: Drug: succinylcholine
Drug: rocuronium
Drug: sugammadex

First Posted Date: 2008-09-11

Last Posted Date: 2015-06-30

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 161

Registration Number: NCT00751179

Comparison of Sugammadex With Neostigmine During Laparoscopic Cholecystectomy or Appendectomy (P05699)

Phase 3

Completed

Conditions: Anesthesia, General

Interventions: Drug: Rocuronium
Drug: Sugammadex
Drug: Neostigmine
Drug: Atropine

First Posted Date: 2008-07-30

Last Posted Date: 2017-05-16

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 140

Registration Number: NCT00724932

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