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

NCT00420680 | Completed Phase 3

• 3 other identifiers: P05934EudraCT Number: 2005-002000-4219.4.309
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• to evaluate the safety of 2.0 and 4.0 mg/kg sugammadex in cardiac patients compared to placebo

  after surgery

Secondary Outcomes (1)

• 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

Study Arms (3)

Arm 1

EXPERIMENTAL

Sugammadex 2.0 mg/kg

Drug: Sugammadex

Arm 2

EXPERIMENTAL

Sugammadex 4.0 mg/kg

Drug: Sugammadex

Arm 3

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Sugammadex DRUG

Sugammadex, 2.0 mg/kg given as a reversal agent at reappearance of T2 after 0.6 mg/kg rocuronium

Also known as: Org 25969

Arm 1

Placebo DRUG

Placebo given at reappearance of T2 after 0.6 mg/kg rocuronium

Arm 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related 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. doi: 10.1097/EJA.0b013e32832c605b.

  PMID: 19455040 RESULT

Related Links

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

MeSH Terms

Interventions

Sugammadex

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2007
• First Posted: January 11, 2007
• Study Start: November 7, 2005
• Primary Completion: August 1, 2006
• Study Completion: August 1, 2006
• Last Updated: August 22, 2017

Record last verified: 2017-08