Sugammadex and Heart Failure

Phase 3

Completed

• Conditions: Postoperative Neuromuscular Block
• Interventions: Drug: Sugammadex

• Registration Number: NCT01509651
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-01
• Study First Submitted QC: 2012-01-10
• Study First Posted: 2012-01-13
• Primary Completion: 2012-03
• Status Verified: 2012-04
• Study Completion: 2012-04
• Last Update Submitted: 2012-04-03
• Last Update Posted: 2012-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sugammadex	Sugammadex	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

OLV Hospital; 🇧🇪 Aalst, Belgium