Impact of Sugammadex vs. Neostigmine Reversal on Post-Operative Recovery and Complications

Study Overview
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Brief Summary
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Sugammadex or neostigmine are given at the end of the surgery to reverse neuro muscular blocking drugs. 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
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Sugammadex and neostigmine are Neuromuscular Blocking Drugs(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 extubation 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

Official Title
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Impact of Sugammadex vs. Neostigmine Reversal on Post-Operative Recovery And Postoperative Complications In Patients With Obstructive Sleep Apnea Undergoing Bariatric Surgery: A Double-Blind, Randomized Controlled Trial

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Drug: Sugammadex Sodium
* Drug: Neostigmine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years old Diagnosed Obstructive Sleep Apnea patients by polysomnography Scheduled elective bariatric surgery Exclusion Criteria: Age<18 years old Allergy to rocuronium Allergy to sugammadex Allergy to neostigmine Malignant hyperthermia Hepatic insufficiency Renal insufficiency Neuromuscular Disease Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study is a prospective, double-blinded randomized controlled superiority trial with two parallel groups. Randomization will be performed with a 1:1 allocation into reversal of NMBD with sugammadex or neostigmine.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional Arm<br>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 | Drug: Sugammadex Sodium<br>* Sugammadex is a FDA approved newer NMBD reversal agent. But does not use in standard of care in most of institutions This study is designed to compare the impact of reversal of neuromuscular blockade with sugammadex vs. neostigmine on discharge time from the operating room in obese patients with OSA undergoing bariatric surgery<br>* Other names: Bridion;|
| Active Comparator: Standard drug Arm<br>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 | Drug: Neostigmine<br>* neostigmine is a FDA approved NMBD reversal drug, uses as standard care drug in most of the institutions. neostigmine use as active comparator to compare with investigational drug Sugammadex in the study.<br>* Other names: prostigmin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to discharge from operating room | Time from study drug administration to discharge from operating room | 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time the patient open eyes to command | Time from study drug administration to the patient open eyes to command. | 15 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Recovery time, reversal of neuromuscular blockers, obstructive sleep apnea, morbid obesity, bariatric surgery