Sugammadex and Heart Failure

Study Overview
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Brief Summary
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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.

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

Conditions
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Postoperative Neuromuscular Block

Intervention / Treatment
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* Drug: Sugammadex


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sugammadex<br> | Drug: Sugammadex<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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antagonists neuromuscular block, neuromuscular block, monitoring, neuromuscular function