At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 224 enrolled

Drug / intervention

Sugammadex +1 moredrug

Likely dose

Sugammadex 4.0 mg/kgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00298831

NCT00298831Phase 3Completed

Compare CT.gov

A Multicenter, Open Label, Phase IIIa Trial to Evaluate the Efficacy and Safety of Org 25969 When Used at the End of a Surgical Procedure to Reverse the Neuromuscular Block Induced by Rocuronium Following Routine Anesthesia

Merck Sharp & Dohme LLC·interventional·Posted Mar 3, 2006·Updated Mar 27, 2019

In Brief

A Phase 3 clinical trial evaluating Sugammadex and Rocuronium for Anesthesia, General. Completed, enrolled 224 participants.

Detailed Summary

The primary purpose of the study is to determine the time-course of recovery to a T4/T1 ratio of 0.9 within 4 minutes after 4.0 mg.kg\^-1 Sugammadex is administered at least 15 minutes after the last administration of rocuronium in a wide range of surgical procedures and anesthetic regimens (routine use). Safety evaluation is part of the study.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsAnesthesia, General

Countries--

Collaborators--

Timeline

Phase 3CompletedFinished

2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartOct 2005

First PostedMar 2006

Primary CompletionMay 2006

TodayJul 2026

First PostedMar 3, 2006

Enrollment StartOct 27, 2005

Primary CompletionMay 22, 2006

TodayJul 2, 2026

Enrollment to primary: 7 monthsPosted 20.3 years ago

Interventions

Sugammadexdrug

At least 15 minutes after the intubation dose or the last maintenance dose of rocuronium, an intravenous single bolus dose of 4.0 mg/kg Org 25969 was administered.

Rocuroniumdrug

Each participant received an intravenous single bolus dose of 0.6 mg/kg rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg/kg rocuronium was/were administered.