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

Anesthesia Clinical Trial

Official title:

A Multi -Center, Randomized, Parallel-Group, Placebo-Controlled, Safety Assessor-Blinded Trial, Evaluating the Safety and Efficacy of Sugammadex in Cardiac Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00420680
• Other study ID #: P05934
• Secondary ID: EudraCT Number:
• Status: Completed
• Phase: Phase 3
• First received: January 10, 2007
• Last updated: August 18, 2017
• Start date: November 7, 2005
• Est. completion date: August 1, 2006

Study information

• Verified date: August 2017
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 1, 2006
• Est. primary completion date: August 1, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• Sugammadex
Sugammadex, 2.0 mg/kg given as a reversal agent at reappearance of T2 after 0.6 mg/kg rocuronium
• Sugammadex
Sugammadex, 4.0 mg/kg given as a reversal agent at reappearance of T2 after 0.6 mg/kg rocuronium.
• Placebo
Placebo given at reappearance of T2 after 0.6 mg/kg rocuronium

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to evaluate the safety of 2.0 and 4.0 mg/kg sugammadex in cardiac patients compared to placebo		after surgery
Secondary	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		after surgery

External Links

•   Click here to access a synopsis of the study results.