Comparison of the Efficacy, Safety, and Pharmacokinetics of Sugammadex (MK-8616; Org 25969) in Elderly Participants With Adult Participants (MK-8616-029)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-29

Study Completion Date

2006-10-20

Brief Summary

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The purpose of the study is to compare the effectiveness, safety and pharmacokinetics of sugammadex in participants 65 and over with participants under 65. There is no hypothesis defined for the study.

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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

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Participants 18 to 64 years old

Participants to receive an intravenous (IV) single bolus dose of 0.6 mg.kg-1 rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg.kg-1 rocuronium were to be administered. After the intubation dose or the last maintenance dose of rocuronium, participants were to be reversed at reappearance of second twitch (T2) with an intravenous single bolus dose of 2.0 mg.kg-1 of sugammadex.

Group Type EXPERIMENTAL

Sugammadex

Intervention Type DRUG

Rocurium

Intervention Type DRUG

intravenous (IV) single bolus dose of 0.6 mg.kg-1

Participants 65 to 74 years old

Participants to receive an IV single bolus dose of 0.6 mg.kg-1 rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg.kg-1 rocuronium were to be administered. After the intubation dose or the last maintenance dose of rocuronium, participants were to be reversed at reappearance of T2 with an intravenous single bolus dose of 2.0 mg.kg-1 of sugammadex.

Group Type EXPERIMENTAL

Sugammadex

Intervention Type DRUG

Rocurium

Intervention Type DRUG

intravenous (IV) single bolus dose of 0.6 mg.kg-1

Participants 75 years and older

Participants to receive an IV single bolus dose of 0.6 mg.kg-1 rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg.kg-1 rocuronium were to be administered. After the intubation dose or the last maintenance dose of rocuronium, participants were to be reversed at reappearance of T2 with an intravenous single bolus dose of 2.0 mg.kg-1 of sugammadex.

Group Type EXPERIMENTAL

Sugammadex

Intervention Type DRUG

Rocurium

Intervention Type DRUG

intravenous (IV) single bolus dose of 0.6 mg.kg-1

Interventions

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Sugammadex

Intervention Type DRUG

Rocurium

intravenous (IV) single bolus dose of 0.6 mg.kg-1

Intervention Type DRUG

Other Intervention Names

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Org 25969; MK-8616

Eligibility Criteria

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Inclusion Criteria

* American Society of Anesthesiologists (ASA) Class 1 to 3
* 18 years of age or older
* Scheduled for elective surgical procedure under general anesthesia requiring neuromuscular block with the use of rocuronium
* Scheduled for surgery in supine position
* Given written informed consent

Exclusion Criteria

* Participants in whom a difficult intubation is expected due to anatomical malformations
* Participants known or suspected to have neuromuscular disorders impairing neuromuscular blockade and/or significant renal dysfunction
* Participants known or suspected to have a (family) history of malignant hyperthermia
* Participants known or suspected to have an allergy to narcotics, muscle relaxants or other medications used during surgery
* Participants receiving medication known to interfere with neuromuscular blocking agents such as anticonvulsants, antibiotics and magnesium
* Female participants who are pregnant or breast-feeding
* Females participants of childbearing potential not using an acceptable method of birth control \[condom or diaphragm with spermicide, vasectomized partner (\> 6 months), intrauterine device (IUD), abstinence\]
* Participants who had already participated in a Org 25969 trial including Protocol 19.4.305
* Participants who had participated in another clinical trial, not pre-approved by Organon, within 30 days of entering into Protocol 19.4.305

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No