Impact of Sugammadex vs. Neostigmine Reversal on Post-Operative Recovery and Complications
- Conditions
- Obstructive Sleep Apnea
- Interventions
- Registration Number
- NCT03679611
- Lead Sponsor
- University Health Network, Toronto
- Brief Summary
Sugammadex or neostigmine are given at the end of the surgery to reverse neuro muscular blocking drugs (NMBD). This study will evaluate whether reversal of NMBD with sugammadex is associated with faster recovery than neostigmine resulting in faster discharge from the operating room (OR) in obese patients with OSA undergoing bariatric surgery. Half of the patients in the study will receive sugammadex and the other half of the patients will receive neostigmine.
- Detailed Description
Sugammadex and neostigmine are NMBD reversal agents. Neostigmine - an anticholinesterase is given to reverse NMBD; however reversal of NMBD with neostigmine may be associated with residual neuromuscular blockade in up to 64% patients postoperatively in the post anesthesia care unit. Even mild degrees of residual neuromuscular blockade can have serious clinical consequences in the postoperative period. The severity of OSA often worsens after surgery and patients with OSA are at increased risk for early respiratory complications after extubating and in the PACU. Morbid obesity is associated with critical respiratory complications in patients with OSA.
Sugammadex is a newer NMBD reversal agent that rapidly and completely reverses rocuronium. It is a modified gamma cyclodextrin that forms a complex with the neuromuscular blocking agent rocuronium. It reduces the amount of neuromuscular blocking agent available to bind to nicotinic cholinergic receptors in the neuromuscular junction. It has been shown to more rapidly reverse residual neuromuscular blockade than neostigmine in obese patients without obstructive sleep apnea (OSA).
This study will evaluate whether reversal of NMBD with sugammadex is associated with faster recovery than neostigmine resulting in faster discharge from the operating room (OR) in obese patients with OSA undergoing bariatric surgery. Half of the patients in the study will receive sugammadex and other half of the patients will receive neostigmine
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- Age ≥ 18 years old
- Diagnosed Obstructive Sleep Apnea patients by polysomnography
- Scheduled elective bariatric surgery
- Age<18 years old
- Allergy to rocuronium
- Allergy to sugammadex
- Allergy to neostigmine
- Malignant hyperthermia
- Hepatic insufficiency
- Renal insufficiency
- Neuromuscular Disease
- Pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Interventional Arm Sugammadex Sodium Interventional Arm will receive sugammadex sodium 2 mg/kg actual body weight, At the end of surgery Sugammadex will be administered when the TOF reveals at least 2 responses Standard drug Arm Neostigmine standard drug Arm will receive neostigmine 2.5 mg and glycopyrrolate 0.4 mg, At the end of surgery neostigmine and glycopyrrolate will be administered when the TOF reveals at least 2 responses
- Primary Outcome Measures
Name Time Method Time to Discharge From Operating Room 15 minutes The time from study drug administration to discharge from operating room (OR).
- Secondary Outcome Measures
Name Time Method Time the Patient Open Eyes to Command 15 minutes Time from study drug administration to the patient open eyes to command.
Related Research Topics
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Trial Locations
- Locations (1)
Toronto Western Hospital
🇨🇦Toronto, Ontario, Canada