Study of Sugammadex Versus Usual Care on Incidence of Residual Blockade at Post Anesthesia Care Unit Admission (P07981)
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 Neuromuscular Blockade (NMB) as Defined by a Train-of-Four (TOF) Ratio <0.9 at Post Anesthesia Care Unit (PACU) Entry [ Time Frame: At PACU entry on Day 1 ] [ Designated as safety issue: No ]Neuromuscular functioning was monitored by applying three TOF electrical stimulations to the ulnar nerve and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB, with a higher ratio indicating greater recovery from NMB. A T4/T1 Ratio of <0.9 is indicative of residual NMB.
- Time From Start of Study Drug Administration to Operating Room Discharge-ready [ Time Frame: Day 1 ] [ Designated as safety issue: No ]The time of operating room discharge readiness was determined by the surgical team based on clinical evaluations.
|Study Start Date:||December 2011|
|Study Completion Date:||November 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
Participants receive sugammadex, 2 or 4 mg/kg-1, depending on level of neuromuscular recovery
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
Participants receive neostigmine/glycopyrrolate per usual practice
neostigmine, per usual practiceDrug: Glycopyrrolate
glycopyrrolate per usual practice
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