Clinical trial NCT00420680: Safety and Efficacy Evaluation of Sugammadex in Cardiac Patients (19.4.309)(P05934)
Official title: A Multi -Center, Randomized, Parallel-Group, Placebo-Controlled, Safety Assessor-Blinded Trial, Evaluating the Safety and Efficacy of Sugammadex in Cardiac Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anesthesia
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-01-11
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: to evaluate the safety of 2.0 and 4.0 mg/kg sugammadex in cardiac patients compared to placebo
timeFrame: after surgery
Secondary outcomes:
measure: 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
timeFrame: after surgery
Other outcomes:
Locations:
Study officials:
References:
citation: Dahl V, Pendeville PE, Hollmann MW, Heier T, Abels EA, Blobner M. Safety and efficacy of sugammadex for the reversal of rocuronium-induced neuromuscular blockade in cardiac patients undergoing noncardiac surgery. Eur J Anaesthesiol. 2009 Oct;26(10):874-84. doi: 10.1097/EJA.0b013e32832c605b.