Status:
COMPLETED
Safety and Efficacy Evaluation of Sugammadex in Cardiac Patients (19.4.309)(P05934)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Anesthesia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 7 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2006
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00420680
Start Date
November 7 2005
End Date
August 1 2006
Last Update
August 22 2017
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