Safety and Efficacy Evaluation of Sugammadex in Cardiac Patients (19.4.309)(P05934)
- Registration Number
- NCT00420680
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 3 Placebo Placebo Arm 2 Sugammadex Sugammadex 4.0 mg/kg Arm 1 Sugammadex Sugammadex 2.0 mg/kg
- Primary Outcome Measures
Name Time Method to evaluate the safety of 2.0 and 4.0 mg/kg sugammadex in cardiac patients compared to placebo after surgery
- Secondary Outcome Measures
Name Time Method 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