Safety and Efficacy Evaluation of Sugammadex in Cardiac Patients (19.4.309)(P05934)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-07

Study Completion Date

2006-08-01

Brief Summary

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The purpose of this study is to evaluate the safety of 2.0 mg/kg and 4.0 mg/kg sugammadex given as a reversal agent at reappearance of T2 after 0.6 mg/kg rocuronium in cardiac patients

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Detailed Description

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Conditions

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Anesthesia

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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Arm 1

Sugammadex 2.0 mg/kg

Group Type EXPERIMENTAL

Sugammadex

Intervention Type DRUG

Sugammadex, 2.0 mg/kg given as a reversal agent at reappearance of T2 after 0.6 mg/kg rocuronium

Arm 2

Sugammadex 4.0 mg/kg

Group Type EXPERIMENTAL

Sugammadex

Intervention Type DRUG

Sugammadex, 4.0 mg/kg given as a reversal agent at reappearance of T2 after 0.6 mg/kg rocuronium.

Arm 3

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo given at reappearance of T2 after 0.6 mg/kg rocuronium

Interventions

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Sugammadex

Sugammadex, 2.0 mg/kg given as a reversal agent at reappearance of T2 after 0.6 mg/kg rocuronium

Intervention Type DRUG

Sugammadex

Sugammadex, 4.0 mg/kg given as a reversal agent at reappearance of T2 after 0.6 mg/kg rocuronium.

Intervention Type DRUG

Placebo

Placebo given at reappearance of T2 after 0.6 mg/kg rocuronium

Intervention Type DRUG

Other Intervention Names

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Org 25969 Org 25969

Eligibility Criteria

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Inclusion Criteria

* Cardiac patients of NYHA Class II to III
* ASA class maximally 4
* Age at least 18
* Scheduled for elective, non-cardiac surgery under general anesthesia with propofol in the supine position, with planned muscle relaxation using rocuronium and allowing for 12-lead ECG assessment during surgery;
* Given written informed consent.

Exclusion Criteria

* Disorders interfering with the reliability of the assessments (e.g. ECG measurements), such as paroxysmal atrial fibrillation or the presence of a pacemaker
* Known or suspected neuromuscular disorders impairing NMB
* Known or suspected significant renal dysfunction
* Known or suspected (family) history of malignant hyperthermia
* Known or suspected allergy to narcotics, muscle relaxants or other medication used during general anesthesia
* Intended) use of medication expected to interfere with the effect of rocuronium as given in this trial, based on the dose and/or the time of administration (such as antibiotics, anticonvulsants and Mg2+ )
* Pregnancy (pregnancy to be excluded for women both from medical history and by an hCG test within 24 h before surgery, except for women who were not of childbearing potential, i.e. at least 2 years menopausal or have undergone tubal ligation or a hysterectomy)
* Childbearing potential without using any method of birth control or using only hormonal contraception as birth control (subjects were allowed to participate if they were willing to use a condom, or a diaphragm with spermicide, or IUD, or have a vasectomized partner (\>6 months) or abstinence, for one month after participation in the trial)
* Breast -feeding
* Prior participation in any trial with Org 25969
* Participation in another clinical trial not pre -approved by Organon, within 30 days of entering into trial 19.4.309

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No