Sugammadex and Heart Failure

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Guy CAMMU, Onze Lieve Vrouw Hospital
ClinicalTrials.gov Identifier:
NCT01509651
First received: January 1, 2012
Last updated: April 3, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Postoperative Neuromuscular Block
Drug: Sugammadex
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Reversal of Rocuronium-induced Neuromuscular Block With Sugammadex in Heart Failure Patients

Resource links provided by NLM:


Further study details as provided by Onze Lieve Vrouw Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Adverse hemodynamic events. [ Time Frame: From anesthesia induction until 3h after arrival in the postanaesthesia care unit (PACU). ] [ Designated as safety issue: Yes ]
  • Adverse respiratory events (SpO2 <90% and/or signs of airway obstruction). [ Time Frame: From arrival in the PACU until 30min thereafter. ] [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: January 2012
Study Completion Date: April 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01509651

Locations
Belgium
OLV Hospital
Aalst, Belgium, 9300
Sponsors and Collaborators
Onze Lieve Vrouw Hospital
Investigators
Principal Investigator: Guy Cammu, MD, PhD OLV Hospital, Anesthesiology and CCM, Aalst, Belgium
  More Information

Publications:
Responsible Party: Guy CAMMU, MD, PhD, Staff Anesthesiologist, Onze Lieve Vrouw Hospital
ClinicalTrials.gov Identifier: NCT01509651     History of Changes
Other Study ID Numbers: B126201112363
Study First Received: January 1, 2012
Last Updated: April 3, 2012
Health Authority: Belgium: Ethics Committee

Keywords provided by Onze Lieve Vrouw Hospital:
antagonists neuromuscular block
neuromuscular block, monitoring
neuromuscular function

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Rocuronium
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014