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

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

Safety and Efficacy of Sugammadex (Org 25969, MK-8616) in Participants With or Having a Past History of Pulmonary Disease (19.4.308) (P05932) (MK-8616-017)

Phase 3

Completed

Conditions: Anesthesia, General

Interventions: Drug: Sugammadex
Drug: Rocuronium

First Posted Date: 2007-05-21

Last Posted Date: 2019-04-12

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 86

Registration Number: NCT00475215

Comparison of the Efficacy, Safety, and Pharmacokinetics of Sugammadex (MK-8616; Org 25969) in Elderly Participants With Adult Participants (MK-8616-029)

Phase 3

Completed

Conditions: Anesthesia, General

Interventions: Drug: Sugammadex
Drug: Rocurium

First Posted Date: 2007-05-17

Last Posted Date: 2019-04-02

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 162

Registration Number: NCT00474617

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)

Phase 3

Completed

Conditions: Anesthesia, General

Interventions: Drug: Sugammadex
Drug: Succinylcholine
Drug: Rocuronium

First Posted Date: 2007-05-16

Last Posted Date: 2019-04-11

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 115

Registration Number: NCT00474253

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)

Phase 3

Completed

Conditions: Anesthesia, General

Interventions: Drug: neostigmine
Drug: sugammadex
Drug: vecuronium
Drug: rocuronium
Drug: glycopyrrolate

First Posted Date: 2007-05-15

Last Posted Date: 2019-03-19

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 182

Registration Number: NCT00473694

Comparison of Sugammadex (Org 25969) With Neostigmine as Reversal Agents for Rocuronium or Vecuronium at Reappearance of T2 (P05960)

Phase 3

Completed

Conditions: Anesthesia, General

Interventions: Drug: Sugammadex
Drug: Neostigmine

First Posted Date: 2007-03-23

Last Posted Date: 2019-03-04

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 198

Registration Number: NCT00451217

Comparison of Rocuronium and Org 25969 With Cisatracurium and Neostigmine (19.4.310)(P05931)

Phase 3

Completed

Conditions: Anesthesia, General

Interventions: Drug: Sugammadex
Drug: neostigmine

First Posted Date: 2007-03-23

Last Posted Date: 2019-11-15

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 84

Registration Number: NCT00451100

Dose-Finding Pediatric and Adult Trial With Sugammadex (Org 25969, MK-8616, SCH 900616) (19.4.306) (MK-8616-034) (P05961)

Phase 3

Completed

Conditions: Anesthesia

Interventions: Drug: Sugammadex 4 mg/kg
Drug: Sugammadex 0.5 mg/kg
Drug: Sugammadex 1 mg/kg
Drug: Sugammadex 2 mg/kg
Drug: Placebo
Drug: Rocuronium bromide

First Posted Date: 2007-01-11

Last Posted Date: 2019-01-28

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 94

Registration Number: NCT00421148

Safety and Efficacy Evaluation of Sugammadex in Cardiac Patients (19.4.309)(P05934)

Phase 3

Completed

Conditions: Anesthesia

Interventions: Drug: Placebo
Drug: Sugammadex

First Posted Date: 2007-01-11

Last Posted Date: 2017-08-22

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 120

Registration Number: NCT00420680

Use of Sugammadex Administered at 5 Minutes After Administration of 1.2 mg/kg Esmeron® (19.4.205)(P05942)

Phase 2

Completed

Conditions: Anesthesia, General

Interventions: Drug: Placebo
Drug: sugammadex

First Posted Date: 2006-09-22

Last Posted Date: 2017-08-22

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 45

Registration Number: NCT00379613

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