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

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 Overview

• Status: Completed
• Conditions: Anesthesia
• Intervention / Treatment: Drug: Sugammadex; Drug: Neostigmine

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jerry Ingrande, M.D.; Phone Number: 619-543-5560; Email: jingrande@health.ucsd.edu
• Study Contact Backup: Name: Rodney Gabriel, M.D.; Phone Number: 619-543-5560; Email: ragabriel@health.ucsd.edu

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • University of California San Diego

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sugammadex	Drug: Sugammadex; 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).
Placebo Comparator: Neostigmine	Drug: Neostigmine; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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. 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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
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 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.	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
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 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.	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

Collaborators and Investigators

• Sponsor: University of California, San Diego

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2021
• Primary Completion (Actual): January 4, 2023
• Study Completion (Actual): January 4, 2024

Study Registration Dates

• First Submitted: September 17, 2020
• First Submitted That Met QC Criteria: September 25, 2020
• First Posted (Actual): September 30, 2020

Study Record Updates

• Last Update Posted (Actual): April 15, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Enzyme Inhibitors; Cholinesterase Inhibitors; Parasympathomimetics; Neostigmine
• Other Study ID Numbers: MISP 59701

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No