Sugammadex and Heart Failure

April 3, 2012 updated by: Guy CAMMU, Onze Lieve Vrouw Hospital

Reversal of Rocuronium-induced Neuromuscular Block With Sugammadex in Heart Failure Patients

Although anticholinesterase reversal agents have been used in combination with anticholinergic drugs for over half a century, it has been suggested that they should be used with caution in patients with underlying cardiovascular disease. As sugammadex has no endogenous targets, it is unlikely to cause any adverse cardiovascular effects. This selective relaxant binding agent is specifically designed to encapsulate rocuronium, which can, therefore, promptly restore neuromuscular function regardless of any levels of NMB as the dose is increased.

Some reports, however, suggest that sugammadex may have increased time to effect in some patient populations like the elderly, patients in intensive care and renal failure patients. A less dynamic circulation and increased transfer time to the effector site in these subjects are likely explanations for this effect. The present trial was designed to assess the safety and efficacy of sugammadex 2.0 mg kg-1 for the reversal of rocuronium-induced NMB in patients with heart failure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Aalst, Belgium, 9300
        • OLV Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • aged 18 yr or older
  • categorized as American Society of Anesthesiologists class 3-4 and New York Heart Association class 2-4
  • with an ejection fraction <25%
  • scheduled to undergo elective surgery for cardiac resynchronization therapy, an automated implantable cardioverter-defibrillator (ICD), or battery replacement of an ICD or biventricular pacemaker, during general anaesthesia.

Exclusion Criteria:

  • expected to have a difficult intubation for anatomic reasons
  • they had a neuromuscular disorder
  • a personal or family history of malignant hyperthermia
  • or known allergy to medication used during general anaesthesia
  • not able or willing to give written informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sugammadex
Drug: Sugammadex
After the induction of anaesthesia, monitoring neuromuscular function is initiated and performed continuously using the TOF-Watch SX (Organon Ireland Ltd, Ireland) at the thumb. Repetitive train-of four (TOF) stimulation is applied every 15 s at the ulnar nerve until the end of anaesthesia, at least until recovery of the TOF ratio to 0.9 after administration of sugammadex. Each patient receives a single IV bolus dose of rocuronium 0.6 mg kg-1, after which tracheal intubation is performed. Maintenance doses of rocuronium 0.1 mg kg-1, are permitted as required and administered at the reappearance of the second twitch in the TOF. On reappearance of the second twitch at the end of surgery, patients receive a single IV bolus dose of sugammadex, 2.0 mg kg-1, for reversal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The time from start of sugammadex administration to recovery of the train-of-four (TOF) ratio to 0.9.
Time Frame: Participants will be followed for the duration of recovery from neuromuscular block, an expected average of 10min
Participants will be followed for the duration of recovery from neuromuscular block, an expected average of 10min

Secondary Outcome Measures

Outcome Measure
Time Frame
The time from start of sugammadex administration to recovery of the TOF ratio to 0.7 and 0.8.
Time Frame: Participants will be followed for the duration of recovery from neuromuscular block, an expected average of 10min
Participants will be followed for the duration of recovery from neuromuscular block, an expected average of 10min
Adverse hemodynamic events.
Time Frame: From anesthesia induction until 3h after arrival in the postanaesthesia care unit (PACU).
From anesthesia induction until 3h after arrival in the postanaesthesia care unit (PACU).
Adverse respiratory events (SpO2 <90% and/or signs of airway obstruction).
Time Frame: From arrival in the PACU until 30min thereafter.
From arrival in the PACU until 30min thereafter.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Onze Lieve Vrouw Hospital

Investigators

  • Principal Investigator: Guy Cammu, MD, PhD, OLV Hospital, Anesthesiology and CCM, Aalst, Belgium

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

January 1, 2012

First Submitted That Met QC Criteria

January 10, 2012

First Posted (Estimate)

January 13, 2012

Study Record Updates

Last Update Posted (Estimate)

April 4, 2012

Last Update Submitted That Met QC Criteria

April 3, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B126201112363

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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