Clinical trial NCT04570150: Optimizing Post-operative Recovery in Bariatric Patients With Obstructive Sleep Apnea Undergoing Outpatient Surgery: A Comparison of Sugammadex and Neostigmine
Official title: Optimizing Post-operative Recovery in Bariatric Patients With Obstructive Sleep Apnea Undergoing Outpatient Surgery: A Comparison of Sugammadex and Neostigmine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2020-09-30
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time to PACU Discharge
timeFrame: 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
Secondary outcomes:
measure: Compare Proportional Changes Between Baseline Peak Expiratory Flow Rates and Postoperative Peak Expiratory Flow Rates Between Subjects Receiving Sugammadex and Those Receiving Neostigmine.
timeFrame: 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
measure: Compare Proportional Changes Between Baseline Peak Forced Expiratory Volume Over 1 Second (FEV1) and Postoperative FEV1 Between Subjects Receiving Sugammadex and Those Receiving Neostigmine.
timeFrame: 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
measure: Compare Proportional Changes Between Baseline Forced Vital Capacity (FVC) and Postoperative FVC Between Subjects Receiving Sugammadex and Those Receiving Neostigmine.
timeFrame: 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
measure: 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.
timeFrame: 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
measure: 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.
timeFrame: 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
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California San Diego
state: California
Study officials:
References: