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

This study has been completed.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00420680
First received: January 10, 2007
Last updated: October 2, 2009
Last verified: October 2009
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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 Schering-Plough:

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
Experimental: Arm 1
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
Other Name: Org 25969
Experimental: Arm 2
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.
Other Name: Org 25969
Placebo Comparator: Arm 3
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

No publications provided

Responsible Party: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00420680     History of Changes
Other Study ID Numbers: 19.4.309, EudraCT Number: 2005-002000-42
Study First Received: January 10, 2007
Last Updated: October 2, 2009
Health Authority: Norway: Norwegian Medicines Agency

ClinicalTrials.gov processed this record on May 23, 2013