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

Associated Therapies: -

Clinical Trials

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)

Phase 3

Completed

Conditions: Anesthesia

Interventions: Drug: Sugammadex
Drug: Neostigmine
Drug: Rocuronium

First Posted Date: 2008-05-12

Last Posted Date: 2015-03-13

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 100

Registration Number: NCT00675792

Dialysis of Sugammadex in Participants With Severe Renal Impairment (Study 19.4.333) (P05773)

Phase 3

Completed

Conditions: Neuromuscular Blockade

Interventions: Drug: sugammadex
Drug: Rocuronium

First Posted Date: 2008-04-11

Last Posted Date: 2015-03-10

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 6

Registration Number: NCT00656799

A Bridging Trial Comparing Sugammadex (Org 25969) at Reappearance of T2 in Japanese and Caucasian Participants. Part A: Japanese Participants (P05956)

Phase 2

Completed

Conditions: Anesthesia, General

Interventions: Drug: Placebo
Drug: sugammadex

First Posted Date: 2008-01-11

Last Posted Date: 2019-03-01

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 100

Registration Number: NCT00591409

A Bridging Trial Comparing Sugammadex (Org 25969) at 1-2 Post-Tetanic Count (PTC) in Japanese Participants. Part A (P05957)

Phase 2

Completed

Conditions: Anesthesia, General

Interventions: Drug: Sugammadex

First Posted Date: 2008-01-11

Last Posted Date: 2019-03-15

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 100

Registration Number: NCT00591786

Sugammadex After Continuous Infusion of Rocuronium During Sevoflurane and Propofol Anesthesia (P05949; MK-8616-028)

Phase 3

Completed

Conditions: Anesthesia, General

Interventions: Drug: Sugammadex
Drug: Rocuronium
Drug: Sevoflurane
Drug: Propofol

First Posted Date: 2007-11-16

Last Posted Date: 2019-11-25

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 52

Registration Number: NCT00559468

A Bridging Trial Comparing Sugammadex (Org 25969) at Reappearance of T2 in Japanese and Caucasian Participants. Part B: Caucasian Participants (P05971)

Phase 2

Completed

Conditions: Anesthesia, General

Interventions: Drug: Placebo
Drug: Sugammadex
Drug: Vecuronium
Drug: Rocuronium

First Posted Date: 2007-11-02

Last Posted Date: 2019-11-25

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 100

Registration Number: NCT00552617

A Bridging Trial Comparing Sugammadex (Org 25969) at 1-2 Post-Tetanic Count (PTC) in Caucasian Participants. Part B (P05974)

Phase 2

Completed

Conditions: Anesthesia, General

Interventions: Drug: Sugammadex

First Posted Date: 2007-11-02

Last Posted Date: 2019-03-05

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 102

Registration Number: NCT00552929

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)

Phase 2

Completed

Conditions: Anesthesia, General

Interventions: Drug: Placebo
Drug: Sugammadex
Drug: Esmeron®

First Posted Date: 2007-09-26

Last Posted Date: 2019-02-11

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 174

Registration Number: NCT00535743

Relation Between TOF-Watch® SX and a Peripheral Nerve Stimulator After 4.0 mg.Kg-1 Sugammadex (P05698)

Phase 3

Completed

Conditions: Neuromuscular Blockade

Interventions: Drug: sugammadex

First Posted Date: 2007-09-26

Last Posted Date: 2015-03-17

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 91

Registration Number: NCT00535496

Efficacy, Pharmacokinetics and Safety of Org 25969 in Subjects With Normal or Impaired Renal Function (19.4.304)(P05948)(COMPLETED)

Phase 3

Completed

Conditions: Anesthesia, General

Interventions: Drug: Sugammadex

First Posted Date: 2007-06-05

Last Posted Date: 2017-06-16

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 30

Registration Number: NCT00482599

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