Skip to main content
OpenTrials
Completed

NCT Number: NCT01509651

Sugammadex and Heart Failure

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postoperative Neuromuscular Block

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

OLV Hospital

Aalst, 9300, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sugammadex

Drug

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Onze Lieve Vrouw Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jan 13, 2012
Registry last updated
Apr 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.