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

University of California, San Diego90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Anesthesia

Interventions

SugammadexDRUG

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).

NeostigmineDRUG

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).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

University of California San Diego

La Jolla, California, United States

Outcomes

Primary Outcomes

Time to PACU Discharge

Time it takes from admittance to discharge from PACU.

Time frame: 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

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 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.

Time frame: 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

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 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.

Time frame: 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

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) 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.

Data from ClinicalTrials.gov

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