Anesthesia, General Clinical Trial
Official title:
A Multi-center, Randomized, Parallel-group, Comparative, Active-controlled, Safety-assessor Blinded Trial in Adult Subjects Comparing the Efficacy and Safety of Sugammadex (SCH 900616, ORG 25969) Administered at 1-2 PTC With Neostigmine Administered at Reappearance of T2 in Subjects Undergoing Laparoscopic Cholecystectomy or Appendectomy Under Propofol Anesthesia
The current trial was designed to demonstrate faster recovery from a neuromuscular blockade (NMB) induced by rocuronium after reversal at 1-2 Post Tetanic Count (PTC) by 4.0 mg.kg-1 sugammadex compared to 50 µg.kg-1 neostigmine at reappearance of second twitch (T2) in participants undergoing laparoscopic cholecystectomy or appendectomy under propofol anesthesia, to compare safety and to evaluate operating room and Post Anesthetic Care Unit (PACU) length of stay.
In those surgical procedures where a neuromuscular block is desired for intubation and/or
avoid unwanted muscular activity, anesthesiologists may use a more profound NMB until the
end of surgery, e.g. in open abdominal procedures or during laparoscopic procedures in order
to improve surgical conditions. Reversal with sugammadex at a dose of 4.0 mg.kg-1 at 1-2 PTC
after an intubation dose of 0.6 mg.kg-1 or maintenance dosing rocuronium has been found to
be both safe and efficacious in previous clinical trials but has never been investigated
exclusively in participants undergoing laparoscopic cholecystectomy or appendectomy.
With sugammadex profound muscle relaxation may now be provided right up to the end of the
surgical procedure. This may lead to improved Patient Outcomes, such as improvement in the
time from end of surgery to the discharge to the PACU. In this multi-center, randomized,
parallel-group, active-controlled, safety-assessor blinded trial such benefits will be
further investigated.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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