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.
|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|
- 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 ]
- 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 ]
|Study Start Date:||January 2012|
|Study Completion Date:||April 2012|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01509651
|Aalst, Belgium, 9300|
|Principal Investigator:||Guy Cammu, MD, PhD||OLV Hospital, Anesthesiology and CCM, Aalst, Belgium|