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

Study Overview
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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

Official Title
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A Multi -Center, Randomized, Parallel-Group, Placebo-Controlled, Safety Assessor-Blinded Trial, Evaluating the Safety and Efficacy of Sugammadex in Cardiac Patients

Conditions
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Anesthesia

Intervention / Treatment
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* Drug: Sugammadex
* Drug: Sugammadex
* Drug: Placebo


Participation Criteria
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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

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Sugammadex 2.0 mg/kg | Drug: Sugammadex<br>* Sugammadex, 2.0 mg/kg given as a reversal agent at reappearance of T2 after 0.6 mg/kg rocuronium<br>* Other names: Org 25969;|
| Experimental: Arm 2<br>Sugammadex 4.0 mg/kg | Drug: Sugammadex<br>* Sugammadex, 4.0 mg/kg given as a reversal agent at reappearance of T2 after 0.6 mg/kg rocuronium.<br>* Other names: Org 25969;|
| Placebo Comparator: Arm 3<br>Placebo | Drug: Placebo<br>* Placebo given at reappearance of T2 after 0.6 mg/kg rocuronium<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to evaluate the safety of 2.0 and 4.0 mg/kg sugammadex in cardiac patients compared to placebo |  | after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to evaluate the time to recovery from a neuromuscular block induced by rocuronium after reversal at reappearance of T2 by 2.0 and 4.0 mg/kg sugammadex in cardiac patients |  | after surgery |