NCT00535743

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)

A Multi-Center, Randomized, Safety Assessor-Blinded, Placebo- Controlled, Phase II, Parallel Dose-Finding Trial in Subjects of ASA 1-3 to Assess the Efficacy and Safety of 5 Doses of Sugammadex Administered at 3 and 15 Minutes After Administration of 1.0 and 1.2 mg/kg Rocuronium Bromide

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 174 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this trial was to explore the dose-response relation of sugammadex (Org 25969; MK-8616) administered for the reversal of neuromuscular blockade (NMB) at 3 and 15 minutes following administration of 1.0 and 1.2 mg/kg of Esmeron® (rocuronium) in participants receiving surgery, classified as American Society of Anesthesiologists (ASA) class 1 (otherwise normal, healthy participant), class 2 (participant with mild systemic disease), or class 3 (participant with a severe systemic disease that limits activity, but is not incapacitating).

Detailed description

In the United States, the highest dose recommended in the package insert of Zemuron® (i.e. the trade name for Esmeron® in the US) is 1.2 mg/kg whereas in Europe it is 1.0 mg/kg. For both doses, dose recommendations for reversal with sugammadex were to be found. Hence, the present trial was set up to explore the dose-response relation of sugammadex given as an NMB reversal agent at 3 and 15 minutes following administration of 1.0 and 1.2 mg/kg of Esmeron® in subjects of ASA 1 to 3. The sub-investigator who performed any subjective safety assessments after anesthesia was to be remained blinded.

Conditions

• Anesthesia, General

Interventions

Type	Name	Description
DRUG	Sugammadex	Sugammadex administered as a fast IV bolus dose (within 30 seconds) at 3 or 15 minutes following administration of Esmeron®, dosed at 2, 4, 8, 12 or 16 mg/kg according to participant actual body weight.
DRUG	Placebo	0.9% NaCl administered as a fast IV bolus dose (within 30 seconds) at 3 or 15 minutes following administration of Esmeron®,
DRUG	Esmeron®	Esmeron® administered at 1 or 1.2 mg/kg as a fast IV bolus (within 10 seconds), dosed according to participant actual body weight.

Timeline

• Start date: 2004-03-04
• Primary completion: 2004-07-20
• Completion: 2004-07-20
• First posted: 2007-09-26
• Last updated: 2019-02-11
• Results posted: 2019-02-11