Optimizing Post-operative Recovery in Bariatric Patients With Obstructive Sleep Apnea Undergoing Outpatient Surgery: A Comparison of Sugammadex and Neostigmine

Study Overview
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Brief Summary
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This study assesses the efficacy of sugammadex against neostigmine for hastening recovery from neuromuscular blockade and optimizing pulmonary function in obese patients with obstructive sleep apnea presenting for outpatient surgery. Both drugs are used in anesthesiology to reverse neuromuscular blockade that is given in the setting of inducing and maintaining general anesthesia.

Official Title
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Optimizing Post-operative Recovery in Bariatric Patients With Obstructive Sleep Apnea Undergoing Outpatient Surgery: A Comparison of Sugammadex and Neostigmine

Conditions
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Anesthesia

Intervention / Treatment
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* Drug: Sugammadex
* Drug: Neostigmine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: obese (body mass index [BMI] >30 kg/m2) diagnosis of obstructive sleep apnea (OSA) (with or without continuous positive airway pressure [CPAP] use) scheduled for surgery requiring general anesthesia and neuromuscular blockade Exclusion Criteria: history of hepatic, renal, or cardiovascular and/or cerebrovascular dysfunction history of difficult tracheal intubation history of adverse reaction to anesthesia history of adverse reaction to rocuronium, sugammadex, and/or neostigmine/glycopyrrolate

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sugammadex<br> | Drug: Sugammadex<br>* Subjects who are randomized to into the sugammadex arm (Arm I) will receive sugammadex for reversal of neuromuscular block at the completion of their anesthetic; Outcomes measures will be recorded and compared with those from Arm II (neostigmine group).<br>|
| Placebo Comparator: Neostigmine<br> | Drug: Neostigmine<br>* Subjects who are randomized into the neostigmine arm (Arm II) will receive neostigmine for reversal of neuromuscular block at the completion of their anesthetic; Outcomes measures will be recorded and compared with those from Arm I (sugammadex group).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to recover of train of four ratio >0.9 | time to recover from neuromuscular block | measured in OR immediately after sugammadex or neostigmine is administered | 
| Time to PACU discharge | Time it takes from admittance to discharge from PACU | Time to PACU discharge will begin at the time each subject is admitted to the PACU following surgery. The time will end immediately once the subject physically leaves the PACU. The outcome will be measured for each subject on their day of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare pre- and postoperative changes in peak expiratory flow (PEF) | Compare peak expiratory flow (PEF) after sugammadex or neostigmine reversal | Pre-operative peak expiratory flow (PEF) will be measured 10 minutes prior to entry to the operating room; post-operative PEF will be measured 30 minutes after PACU admission | 
| Compare pre- and postoperative changes in forced expiratory volume (FEV1) | Compare forced expiratory volume (FEV1) after sugammadex or neostigmine reversal | Pre-operative forced expiratory volume (FEV1) will be measured 10 minutes prior to entry to the operating room; post-operative FEV1 will be measured 30 minutes after PACU admission | 
| Compare pre- and postoperative changes in forced vital capacity (FVC) | Compare forced vital capacity (FVC) after sugammadex or neostigmine reversal | Pre-operative forced vital capacity (FVC) will be measured 10 minutes prior to entry to the operating room; post-operative FVC will be measured 30 minutes after PACU admission | 
| Compare pre- and post-operative arterial blood gas values (PaO2) | Measure and compare PaO2 levels in subjects who received sugammadex or neostigmine for reversal of neuromuscular block | Pre-operative PaO2 arterial blood gas measurements will be measured 10 minutes prior to entry to the operating room; post-operative PaO2 arterial blood gas measurements will be measured 30 minutes after PACU admission | 
| Compare pre- and post-operative arterial blood gas values (PaCO2) | Measure and compare PaCO2 levels in subjects who received sugammadex or neostigmine for reversal of neuromuscular block | Pre-operative PaCO2 arterial blood gas measurements will be measured 10 minutes prior to entry to the operating room; post-operative PaCO2 arterial blood gas measurements will be measured 30 minutes after PACU admission |