Study of Sugammadex Versus Usual Care on Incidence of Residual Blockade at Post Anesthesia Care Unit Admission (P07981 AM3)
This study will compare the incidence of residual neuromuscular blockade in participants who undergo reversal of neuromuscular blockade with sugammadex compared to those who undergo reversal of neuromuscular blockade with usual care (neostigmine/glycopyrrolate).
Surgical Procedures, Elective
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Effect of Sugammadex Compared With Usual Care for Reversal of Neuromuscular Blockade Induced by Rocuronium on Incidence of Residual Blockade at PACU Entry (Phase 5, Protocol No. P07981 [Also Known as MK 8616-064])|
- Incidence of residual block as defined by a Train-of-Four (TOF) ratio <0.9 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]TOF is a measure of muscle response to 4 consecutive stimuli delivered along the path of a nerve; 4 equal contractions signify no neuromuscular blockade.
- Time from start of medication to operating room discharge-ready [ Time Frame: Day 1 ] [ Designated as safety issue: No ]This is a health outcome measure looking at time and motion parameters that can influence the efficiency of the operating room.
|Study Start Date:||December 2011|
|Study Completion Date:||November 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
sugammadex, intravenous (IV) bolus, 2 or 4 mg/kg-1 depending on level of neuromuscular recovery
Other Name: SCH 900616, MK-8616
|Active Comparator: Neostigmine/glycopyrrolate||
neostigmine, per usual practiceDrug: Glycopyrrolate
glycopyrrolate per usual practice