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

NCT04570150 | Completed Phase 4 Results FDA Drug

• 1 other identifier: MISP 59701
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Sugammadex

ACTIVE COMPARATOR

Drug: Sugammadex

Neostigmine

PLACEBO COMPARATOR

Drug: Neostigmine

Interventions

Sugammadex DRUG

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).

Sugammadex

Neostigmine DRUG

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).

Neostigmine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California San Diego

La Jolla, California, 92037, United States

Location

MeSH Terms

Interventions

Sugammadex; Neostigmine

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates; Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds

Results Point of Contact

• Title: Dr. Rodney Gabriel
• Organization: UCSD

ragabriel@health.ucsd.edu

6194710670

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Clinical Professor

Study Record Dates

• First Submitted: September 17, 2020
• First Posted: September 30, 2020
• Study Start: January 4, 2021
• Primary Completion: January 4, 2023
• Study Completion: January 4, 2024
• Last Updated: April 15, 2024
• Results First Posted: January 5, 2024

Record last verified: 2024-03

Locations

US (1)