Safety and Efficacy of Sugammadex (Org 25969, MK-8616) in Participants With or Having a Past History of Pulmonary Disease (19.4.308) (P05932) (MK-8616-017)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-27

Study Completion Date

2006-09-09

Brief Summary

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The purpose of the trial is to research the safety and to show faster recovery after administration of 2.0 mg/kg or 4.0 mg/kg sugammadex (Org 25969, MK-8616) given as a reversal agent for 0.6 mg/kg (0.15 mg/kg maintenance dose) rocuronium (Zemuron®) in participants diagnosed with or having a history of pulmonary disease. All drug administration will be via the intravenous (IV) route.

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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 2.0 mg/kg

After the IV intubation dose (0.6 mg/kg) or last maintenance dose (0.15 mg/kg) of rocuronium, at reappearance of T2, participants will receive IV sugammadex 2.0 mg/kg.

Group Type EXPERIMENTAL

Sugammadex

Intervention Type DRUG

Sugammadex solution for injection.

Rocuronium

Intervention Type DRUG

Rocuronium bromide solution for injection.

Rocuronium + Sugammadex 4.0 mg/kg

After the IV intubation dose (0.6 mg/kg) or last maintenance dose (0.15 mg/kg) of rocuronium, at reappearance of T2, participants will receive IV sugammadex 4.0 mg/kg.

Group Type EXPERIMENTAL

Sugammadex

Intervention Type DRUG

Sugammadex solution for injection.

Rocuronium

Intervention Type DRUG

Rocuronium bromide solution for injection.

Interventions

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Sugammadex

Sugammadex solution for injection.

Intervention Type DRUG

Rocuronium

Rocuronium bromide solution for injection.

Intervention Type DRUG

Other Intervention Names

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Org 25969, MK-8616, Bridion® Zemuron®

Eligibility Criteria

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Inclusion Criteria

* American Society of Anesthesiologists (ASA) Class 1 to 3;
* Has been diagnosed with or having a past history of pulmonary disease;
* Is scheduled for elective surgical procedure under general anesthesia requiring neuromuscular block with the use of rocuronium;
* Is scheduled for surgery in supine position;
* Has given written informed consent;

Exclusion Criteria

* Is expected to have a difficult intubation due to anatomical malformations;
* Has known or suspected of having neuromuscular disorders impairing neuromuscular blockade and/or significant renal dysfunction;
* Has known or suspected of having a (family) history of malignant hyperthermia;
* Has known or suspected of having an allergy to narcotics, muscle relaxants or other medications used during surgery;
* Is receiving medication known to interfere with neuromuscular blocking agents such as anticonvulsants, antibiotics and Mg2+;
* Is a female who is pregnant or breast-feeding;
* Is a female of childbearing potential not using an acceptable method of birth control \[condom or diaphragm with spermicide, vasectomized partner (\> 6 months), IUD, abstinence\] or using only hormonal contraception as birth control;
* Has already participated in a sugammadex trial including Protocol 19.4.308;
* Has participated in another clinical trial, not pre-approved by Organon, within 30 days of entering into Protocol 19.4.308.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No