Comparison of Recovery From Rocuronium 1.2 mg/kg Followed by Sugammadex (Org 25969) 16 mg/kg at 3 Minutes With Recovery From Succinylcholine 1.0 mg/kg (19.4.303)(P05946)(MK-8616-026)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-10

Study Completion Date

2006-09-09

Brief Summary

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The purpose of the trial is to demonstrate a faster recovery from neuromuscular block induced by 1.2 mg/kg rocuronium after reversal at 3 minutes by 16.0 mg/kg of sugammadex compared with recovery after a neuromuscular block induced by 1.0 mg/kg succinylcholine.

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Detailed Description

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Conditions

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Anesthesia, General

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rocuronium + Sugammadex

Participants were to receive a single bolus dose of 1.2 mg/kg rocuronium. Three minutes after the start of the rocuronium administration, they were to receive a single bolus dose of 16.0 mg/kg sugammadex.

Group Type EXPERIMENTAL

Sugammadex

Intervention Type DRUG

Single bolus intravenous (IV) dose of 16.0 mg/kg sugammadex

Rocuronium

Intervention Type DRUG

Single bolus IV dose of 1.2 mg/kg rocuronium

Succinylcholine

Participants were to receive a single bolus dose of 1.0 mg/kg succinylcholine and allowed to recovery spontaneously from neuromuscular blockade.

Group Type ACTIVE_COMPARATOR

Succinylcholine

Intervention Type DRUG

Single bolus IV dose of 1.0 mg/kg succinylcholine

Interventions

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Sugammadex

Single bolus intravenous (IV) dose of 16.0 mg/kg sugammadex

Intervention Type DRUG

Succinylcholine

Single bolus IV dose of 1.0 mg/kg succinylcholine

Intervention Type DRUG

Rocuronium

Single bolus IV dose of 1.2 mg/kg rocuronium

Intervention Type DRUG

Other Intervention Names

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Org 25969 MK-8616 Zemuron®

Eligibility Criteria

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Inclusion Criteria

* American Society of Anesthesiologists (ASA) Class 1 or 2 physical status;
* 18 to 65 years of age (inclusive);
* Scheduled for elective surgical procedure under general anesthesia requiring a short duration of neuromuscular block with the use of rocuronium or succinylcholine and requiring endotracheal intubation;
* Scheduled for surgery in supine position;
* Body mass index (BMI) \< 30;
* Given written informed consent.

Exclusion Criteria

* Has ischemic heart disease or history of myocardial infarction within the last year;
* May experience difficult intubation due to anatomical malformations;
* Known or suspected to have neuromuscular disorders impairing neuromuscular blockade and/or significant renal dysfunction;
* Known or suspected family history of malignant hyperthermia;
* Known or suspected allergy to narcotics, muscle relaxants, midazolam, anesthetics or other medications used during surgery;
* Is receiving medication known to interfere with neuromuscular blocking agents such as anticonvulsants, antibiotics and Mg2+;
* Individuals in whom the use of neostigmine and/or glycopyrrolate may be contraindicated;
* Females who are pregnant or breast-feeding;
* Females of childbearing potential who are not using an acceptable method of birth control \[condom or diaphragm with spermicide, vasectomized partner (\> 6 months), IUD, abstinence\];
* Has already participated in a sugammadex trial including Protocol 19.4.303.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No