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Completed

NCT Number: NCT04570150

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.

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Key information

Conditions

Anesthesia

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of California San Diego

La Jolla, California, 92037, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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).

Primary outcomes

  1. Time to PACU Discharge

    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

    Time it takes from admittance to discharge from PACU.

Secondary outcomes

  1. Compare Proportional Changes Between Baseline Peak Expiratory Flow Rates and Postoperative Peak Expiratory Flow Rates Between Subjects Receiving Sugammadex and Those 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

    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.

  2. Compare Proportional Changes Between Baseline Peak Forced Expiratory Volume Over 1 Second (FEV1) and Postoperative FEV1 Between Subjects Receiving Sugammadex and Those 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

    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.

  3. Compare Proportional Changes Between Baseline Forced Vital Capacity (FVC) and Postoperative FVC Between Subjects Receiving Sugammadex and Those Receiving Neostigmine.

    Time frame: 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.

  4. 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.

    Time frame: 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.

  5. 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.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Sep 30, 2020
Registry last updated
Apr 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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