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

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Safety-Assessor Blinded Trial Comparing Sugammadex With Neostigmine in Korean Subjects Scheduled for Surgeries Requiring Moderate Neuromuscular Blockade

Conditions
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Neuromuscular Blockade

Intervention / Treatment
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* Drug: sugammadex
* Drug: neostigmine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sugammadex<br> | Drug: sugammadex<br>* sugammadex 2.0 mg/kg, single intravenous bolus dose administered within 10 seconds into a fast flowing venous infusion<br>* Other names: SCH 900616; Bridion;|
| Active Comparator: Neostigmine<br> | Drug: neostigmine<br>* neostigmine 50 mcg/kg (total dose not to exceed 5.0 mg) combined with glycopyrrolate 10 mcg/kg, single intravenous bolus dose administered within 10 seconds into a fast flowing venous infusion<br>* Other names: neostigmine methylsulfate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time From Start of Study Drug Administration to Recovery of the T4/T1 Ratio to 0.9 | 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. | From Start of Study Drug Administration to Recovery of the T4/T1 Ratio to 0.9 (estimated from 2 minutes up to  15 minutes) |