CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 86 enrolled
Drug / intervention
Sugammadex +1 moredrug
Likely dose
Not stated in 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/NCT00475215
NCT00475215Phase 3Completed

A Multicenter, Randomized, Parallel Group, Comparative, Safety-Assessor Blinded, Phase IIIa Trial in Adult Surgical Subjects Under General Anesthesia at Increased Risk for Pulmonary Complications

Merck Sharp & Dohme LLC·interventional·Posted May 21, 2007·Updated Apr 12, 2019

In Brief

A Phase 3 clinical trial evaluating Sugammadex and Rocuronium for Anesthesia, General. Completed, enrolled 86 participants.

Detailed Summary

The purpose of the trial is to research the safety and to show faster recovery after administration of 2.0 mg/kg or 4.0 mg/kg sugammadex (Org 25969, MK-8616) given as a reversal agent for 0.6 mg/kg (0.15 mg/kg maintenance dose) rocuronium (Zemuron®) in participants diagnosed with or having a history of pulmonary disease. All drug administration will be via the intravenous (IV) route.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 21, 2007
Enrollment StartOct 27, 2005
Primary CompletionAug 21, 2006
Study CompletionSep 9, 2006
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 19.1 years ago

Interventions

Sugammadexdrug

Sugammadex solution for injection.

Rocuroniumdrug

Rocuronium bromide solution for injection.