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

Phase 4

Completed

• Conditions: Anesthesia
• Interventions: Drug: Sugammadex; Drug: Neostigmine

• Registration Number: NCT04570150
• Lead Sponsor: University of California, San Diego

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-17
• Study First Submitted QC: 2020-09-25
• Study First Posted: 2020-09-30
• Study Start: 2021-01-04
• Primary Completion: 2023-01-04
• Results First Submitted: 2023-11-22
• Results First Submitted QC: 2024-01-02
• Study Completion: 2024-01-04
• Results First Posted: 2024-01-05
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-18
• Last Update Posted: 2024-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sugammadex	Sugammadex	-
Neostigmine	Neostigmine	-

Primary Outcome Measures

Name	Time	Method
Time to PACU Discharge	Time to PACU discharge will begin at the time each subject is admitted to the PACU. The time will end immediately once the subject leaves the PACU up to a period of 300 minutes. The outcome will be measured for each subject on the day of surgery	Time it takes from admittance to discharge from PACU.

Secondary Outcome Measures

Name	Time	Method
Compare Proportional Changes Between Baseline Forced Vital Capacity (FVC) and Postoperative FVC Between Subjects Receiving Sugammadex and Those Receiving Neostigmine.	Baseline 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	Baseline forced vital capacity (FVC) measurements will be measured preoperatively (units: Liters). These values will be compared with FVC measurements. The proportional change (values between 0 and 1) will be compared between subjects receiving sugammadex and subjects receiving neostigmine.
Compare Proportional Changes Between Baseline PaCO2 Measured Via Arterial Blood Gas and Postoperative PaCO2 (Measured Via Arterial Blood Gas) Between Subjects Receiving Sugammadex and Those Receiving Neostigmine.	Baseline 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	Baseline PaCO2 will be measured preoperatively via an arterial blood gas (units: mmHg). These values will be compared with postoperative PaCO2 values also measured via an arterial blood gas. The proportional change (values between 0 and 1) will be compared between subjects receiving sugammadex and subjects receiving neostigmine.
Compare Proportional Changes Between Baseline Peak Expiratory Flow Rates and Postoperative Peak Expiratory Flow Rates Between Subjects Receiving Sugammadex and Those Receiving Neostigmine.	Baseline 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	Baseline peak expiratory flow rates will be measured preoperatively (units: L/min). These values will be compared with postoperative peak expiratory flow rates. The proportional change (values between 0 and 1) will be compared between subjects receiving sugammadex and subjects receiving neostigmine.
Compare Proportional Changes Between Baseline Peak Forced Expiratory Volume Over 1 Second (FEV1) and Postoperative FEV1 Between Subjects Receiving Sugammadex and Those Receiving Neostigmine.	Baseline 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	Baseline FEV1 will be measured preoperatively (units: liters). These values will be compared with postoperative FEV1. The proportional change (values between 0 and 1) will be compared between subjects receiving sugammadex and subjects receiving neostigmine.
Compare Proportional Changes Between Baseline PaO2 Measured Via Arterial Blood Gas and Postoperative PaO2 (Measured Via Arterial Blood Gas) Between Subjects Receiving Sugammadex and Those Receiving Neostigmine.	Baseline 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	Baseline PaO2 will be measured preoperatively via an arterial blood gas (units: mmHg). These values will be compared with postoperative PaO2 values also measured via an arterial blood gas. The proportional change (values between 0 and 1) will be compared between subjects receiving sugammadex and subjects receiving neostigmine.

Trial Locations

Locations (1)

University of California San Diego; 🇺🇸 La Jolla, California, United States