Comparison of Sugammadex With Neostigmine as Reversal Agents for Rocuronium at Reappearance of T2 (Study P06101)

Phase 3

Completed

• Conditions: Neuromuscular Blockade
• Interventions: Drug: neostigmine; Drug: sugammadex

• Registration Number: NCT01050543
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

This is a randomized, active-controlled, parallel-group, single-dose, multi-site, safety-assessor blinded study comparing sugammadex to neostigmine for reversal of neuromuscular blockade in Korean subjects undergoing elective surgical procedures under general anesthesia that require rocuronium for neuromuscular blockade. Study medication will be administered at reappearance of T2. Time to recovery will be measured from start of study medication administration to recovery of the T4/T1 ratio of 0.9. The primary hypothesis is that the time to recovery of the T4/T1 ratio of 0.9 is shorter with sugammadex than with neostigmine.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-01-14
• Study First Submitted QC: 2010-01-14
• Study First Posted: 2010-01-15
• Study Start: 2010-02-01
• Primary Completion: 2010-08-20
• Study Completion: 2010-08-20
• Results First Submitted: 2012-02-13
• Results First Submitted QC: 2012-04-10
• Results First Posted: 2012-05-07
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-01
• Last Update Posted: 2017-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

• American Society of Anesthesiologists Class 1 or 2 or 3
• >=18 years of age and of either sex
• scheduled for elective surgical procedure under general anesthesia requiring the use of rocuronium for endotracheal intubation and/or maintenance of neuromuscular blockade in a supine position allowing neuromuscular transmission monitoring and requiring reversal of neuromuscular blockade
• Korean descent born in Korea, never emigrated out of Korea, and have a Korean home address

Exclusion Criteria

• expected difficult intubation due to anatomic malformations
• expected transfer to intensive care unit after surgery
• neuromuscular disorders affecting neuromuscular blockade
• significant hepatic or renal dysfunction
• require use of pneumatic tourniquet during surgery
• (family) history of malignant hyperthermia
• allergy to cyclodextrins (including sugammadex) or other medication(s) used during general anesthesia; use of toremifene or fusidic acid within 24 hours of study drug administration; contraindication to use of neostigmine or glycopyrrolate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neostigmine	neostigmine	-
Sugammadex	sugammadex	-

Primary Outcome Measures

Name	Time	Method
Time From Start of Study Drug Administration to Recovery of the T4/T1 Ratio to 0.9	From Start of Study Drug Administration to Recovery of the T4/T1 Ratio to 0.9 (estimated from 2 minutes up to ~15 minutes)	Neuromuscular functioning was monitored by applying repetitive Train-Of-Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds \& assessing twitch response at the adductor pollicis muscle. T1 \& T4 refer to the magnitudes (height) of the 1st \& 4th 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 neuromuscular blockade. In this study, twitch responses were recorded until the T4/T1 Ratio reached \>= 0.9, the minimum acceptable ratio that indicated complete recovery.