NCT00473694

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)

A Multicenter, Randomized, Parallel Group Comparative, Active-Controlled, Safety-assessor Blinded. Phase IIIa, Pivotal Trial in Adult Subjects Comparing Org 25969 With Neostigmine as Reversal Agent of a Neuromuscular Block Induced by Maintenance Dosing of Rocuronium or Vecuronium at 1-2 PTCs

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 182 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the trial is to demonstrate a faster recovery from neuromuscular block (NMB) induced with rocuronium or vecuronium after reversal by 4.0 mg/kg of Org 25969 compared with reversal by 70 μg/kg of neostigmine in combination with 14 μg/kg glycopyrrolate.

Conditions

• Anesthesia, General

Interventions

Type	Name	Description
DRUG	sugammadex	Administered as an intravenous (IV) infusion
DRUG	neostigmine	Administered as an IV infusion
DRUG	vecuronium	Administered as an IV infusion
DRUG	rocuronium	Administered as an IV infusion
DRUG	glycopyrrolate	Administered as an IV infusion

Timeline

• Start date: 2005-11-28
• Primary completion: 2006-11-06
• Completion: 2007-01-29
• First posted: 2007-05-15
• Last updated: 2019-03-19
• Results posted: 2019-03-07

Regulatory

• FDA-regulated drug study