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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00420680
First received: January 10, 2007
Last updated: May 7, 2014
Last verified: May 2014
  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 Merck Sharp & Dohme Corp.:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00420680     History of Changes
Other Study ID Numbers: P05934, EudraCT Number: 2005-002000-42, 19.4.309
Study First Received: January 10, 2007
Last Updated: May 7, 2014
Health Authority: Norway: Norwegian Medicines Agency

ClinicalTrials.gov processed this record on October 21, 2014