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Sugammadex and Heart Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01509651
Recruitment Status : Completed
First Posted : January 13, 2012
Last Update Posted : April 4, 2012
Information provided by (Responsible Party):
Guy CAMMU, Onze Lieve Vrouw Hospital

Brief Summary:

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 or disease Intervention/treatment Phase
Postoperative Neuromuscular Block Drug: Sugammadex Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reversal of Rocuronium-induced Neuromuscular Block With Sugammadex in Heart Failure Patients
Study Start Date : January 2012
Actual Primary Completion Date : March 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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.

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Adverse hemodynamic events. [ Time Frame: From anesthesia induction until 3h after arrival in the postanaesthesia care unit (PACU). ]
  3. Adverse respiratory events (SpO2 <90% and/or signs of airway obstruction). [ Time Frame: From arrival in the PACU until 30min thereafter. ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01509651

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

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Responsible Party: Guy CAMMU, MD, PhD, Staff Anesthesiologist, Onze Lieve Vrouw Hospital Identifier: NCT01509651     History of Changes
Other Study ID Numbers: B126201112363
First Posted: January 13, 2012    Key Record Dates
Last Update Posted: April 4, 2012
Last Verified: April 2012
Keywords provided by Guy CAMMU, Onze Lieve Vrouw Hospital:
antagonists neuromuscular block
neuromuscular block, monitoring
neuromuscular function
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs