Safety and Efficacy Evaluation of Sugammadex in Cardiac Patients (19.4.309)(COMPLETED) - Full Text View

Sponsored by:	Organon
Information provided by:	Organon
ClinicalTrials.gov Identifier:	NCT00420680

Purpose

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

Condition	Intervention	Phase
Anesthesia	Drug: Sugammadex Drug: Placebo	Phase III

MedlinePlus related topics: Anesthesia

Drug Information available for: Rocuronium ORG 9426 Sugammadex

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multi -Center, Randomized, Parallel-Group, Placebo-Controlled, Safety Assessor-Blinded Trial, Evaluating the Safety and Efficacy of Sugammadex in Cardiac Patients

Further study details as provided by Organon:

Primary Outcome Measures:

to evaluate the safety of 2.0 and 4.0 mg/kg sugammadex in cardiac patients compared to placebo [ Time Frame: after surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 [ Time Frame: after surgery ] [ Designated as safety issue: No ]

Enrollment:	120
Study Start Date:	November 2005
Study Completion Date:	August 2006
Primary Completion Date:	August 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental Sugammadex 2.0 mg/kg	Drug: Sugammadex Sugammadex, 2.0 mg/kg given as a reversal agent at reappearance of T2 after 0.6 mg/kg rocuronium
Arm 2: Experimental Sugammadex 4.0 mg/kg	Drug: Sugammadex Sugammadex, 4.0 mg/kg given as a reversal agent at reappearance of T2 after 0.6 mg/kg rocuronium.
Arm 3: Placebo Comparator Placebo	Drug: Placebo Placebo given at reappearance of T2 after 0.6 mg/kg rocuronium

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

No Contacts or Locations Provided

More Information

Responsible Party:	NV Organon, part of Schering-Plough Corporation ( Study Director )
Study ID Numbers:	19.4.309, EudraCT Number: 2005-002000-42
Study First Received:	January 10, 2007
Last Updated:	August 8, 2008
ClinicalTrials.gov Identifier:	NCT00420680
Health Authority:	Norway: Norwegian Medicines Agency

Study placed in the following topic categories:

Rocuronium

ClinicalTrials.gov processed this record on January 14, 2009