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

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

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

Study Overview

• Status: Completed
• Conditions: Anesthesia
• Intervention / Treatment: Drug: Sugammadex; Drug: Sugammadex; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Arm 3; Placebo	Drug: Placebo; Placebo given at reappearance of T2 after 0.6 mg/kg rocuronium
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 Names: Org 25969; Drug: Sugammadex; Sugammadex, 4.0 mg/kg given as a reversal agent at reappearance of T2 after 0.6 mg/kg rocuronium.; Other Names: Org 25969
Experimental: Arm 2; Sugammadex 4.0 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 Names: Org 25969; Drug: Sugammadex; Sugammadex, 4.0 mg/kg given as a reversal agent at reappearance of T2 after 0.6 mg/kg rocuronium.; Other Names: Org 25969

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
to evaluate the safety of 2.0 and 4.0 mg/kg sugammadex in cardiac patients compared to placebo	after surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Publications and helpful links

General Publications

• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2005
• Primary Completion (Actual): August 1, 2006
• Study Completion (Actual): August 1, 2006

Study Registration Dates

• First Submitted: January 10, 2007
• First Submitted That Met QC Criteria: January 10, 2007
• First Posted (Estimate): January 11, 2007

Study Record Updates

• Last Update Posted (Actual): August 22, 2017
• Last Update Submitted That Met QC Criteria: August 18, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: P05934; EudraCT Number: 2005-002000-42; 19.4.309

Plan for Individual participant data (IPD)

Study Data/Documents

1. CSR Synopsis