Study of Sugammadex Versus Usual Care on Incidence of Residual Blockade at Post Anesthesia Care Unit Admission (P07981)
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|ClinicalTrials.gov Identifier: NCT01479764|
Recruitment Status : Completed
First Posted : November 24, 2011
Results First Posted : December 31, 2013
Last Update Posted : June 6, 2017
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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).
|Condition or disease||Intervention/treatment||Phase|
|Surgical Procedures, Elective||Drug: Sugammadex Drug: Neostigmine Drug: Glycopyrrolate||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||154 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||December 2, 2011|
|Primary Completion Date :||October 26, 2012|
|Study Completion Date :||November 5, 2012|
Participants receive sugammadex, 2 or 4 mg/kg, depending on level of neuromuscular recovery
sugammadex, intravenous (IV) bolus, 2 or 4 mg/kg 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
Primary Outcome Measures :
- 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 ]Neuromuscular functioning was monitored by applying four 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.
Secondary Outcome Measures :
- Time From Start of Study Drug Administration to Operating Room Discharge-ready [ Time Frame: Day 1 ]The time of operating room discharge readiness was determined by the surgical team based on clinical evaluations.
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