CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 115 enrolled
Drug / intervention
Sugammadex +2 moredrug
Likely dose
Rocuronium 1.2 mg/kg IV bolus followed by sugammadex 16 mg/kg IV bolus at 3 minutesAI-extracted
Key inclusion· 6
  • ✓ASA physical status Class 1 or 2
  • ✓Age 18 to 65 years
  • ✓Elective surgery under general anesthesia requiring short-duration neuromuscular block (rocuronium or succinylcholine) with endotracheal intubation
  • ✓Supine positioning for surgery
Key exclusion· 10
  • ✕Ischemic heart disease or myocardial infarction within the past year
  • ✕Predicted difficult intubation due to anatomical malformations
  • ✕Neuromuscular disorders impairing neuromuscular blockade or significant renal dysfunction
  • ✕Family history of malignant hyperthermia

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00474253
NCT00474253Phase 3Completed
CompareCT.gov

A Multicenter, Randomized, Parallel Group, Comparative, Active-Controlled, Safety-Assessor Blinded, Phase IIIa, Trial, in Adult Subjects Comparing Recovery From 1.2 mg.Kg-1 Rocuronium Followed by 16 mg.Kg-1 Org 25969 at 3 Minutes With Recovery From 1.0 mg.Kg-1 Succinylcholine

Merck Sharp & Dohme LLC·interventional·Posted May 16, 2007·Updated Apr 11, 2019

In Brief

A Phase 3 clinical trial evaluating Sugammadex, Succinylcholine, and 1 other intervention for Anesthesia, General. Completed, enrolled 115 participants.

Detailed Summary

The purpose of the trial is to demonstrate a faster recovery from neuromuscular block induced by 1.2 mg/kg rocuronium after reversal at 3 minutes by 16.0 mg/kg of sugammadex compared with recovery after a neuromuscular block induced by 1.0 mg/kg succinylcholine.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnesthesia, General
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 16, 2007
Enrollment StartFeb 10, 2006
Primary CompletionAug 22, 2006
Study CompletionSep 9, 2006
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 19.1 years ago

Interventions

Sugammadexdrug

Single bolus intravenous (IV) dose of 16.0 mg/kg sugammadex

Succinylcholinedrug

Single bolus IV dose of 1.0 mg/kg succinylcholine

Rocuroniumdrug

Single bolus IV dose of 1.2 mg/kg rocuronium