Study of Sugammadex Versus Usual Care on Incidence of Residual Blockade at Post Anesthesia Care Unit Admission (P07981)
This study has been completed.
Merck Sharp & Dohme Corp.
First Posted: November 24, 2011
Last Update Posted: June 6, 2017
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).
|Surgical Procedures, Elective||Drug: Sugammadex Drug: Neostigmine Drug: Glycopyrrolate||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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|
Resource links provided by NLM:
Drug Information available for: Neostigmine methylsulfate Glycopyrrolate Sugammadex Sugammadex sodiumU.S. FDA Resources
Further study details as provided by Merck Sharp & Dohme Corp.:
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.
|Actual Study Start Date:||December 2, 2011|
|Study Completion Date:||November 5, 2012|
|Primary Completion Date:||October 26, 2012 (Final data collection date for primary outcome measure)|
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
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