Sugammadex and Heart Failure
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|ClinicalTrials.gov Identifier: NCT01509651|
Recruitment Status : Completed
First Posted : January 13, 2012
Last Update Posted : April 4, 2012
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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 ]
- 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 ]
- Adverse hemodynamic events. [ Time Frame: From anesthesia induction until 3h after arrival in the postanaesthesia care unit (PACU). ]
- Adverse respiratory events (SpO2 <90% and/or signs of airway obstruction). [ Time Frame: From arrival in the PACU until 30min thereafter. ]
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 ClinicalTrials.gov identifier (NCT number): NCT01509651
|Aalst, Belgium, 9300|
|Principal Investigator:||Guy Cammu, MD, PhD||OLV Hospital, Anesthesiology and CCM, Aalst, Belgium|