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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Anesthesia

Treatments: Drug: Sugammadex; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00420680

19.4.309

P05934

EudraCT Number: 2005-002000-42

Details and patient eligibility

About

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

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups, including a placebo group

Arm 1

Experimental group

Description:

Sugammadex 2.0 mg/kg

Treatment:

Drug: Sugammadex

Drug: Sugammadex

Arm 2

Experimental group

Description:

Sugammadex 4.0 mg/kg

Treatment:

Drug: Sugammadex

Drug: Sugammadex

Arm 3

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo