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Completed

NCT Number: NCT03679611

Impact of Sugammadex vs. Neostigmine Reversal on Post-Operative Recovery and Complications

Sugammadex or neostigmine are given at the end of the surgery to reverse neuro muscular blocking drugs (NMBD). This study will evaluate whether reversal of NMBD with sugammadex is associated with faster recovery than neostigmine resulting in faster discharge from the operating room (OR) in obese patients with OSA undergoing bariatric surgery. Half of the patients in the study will receive sugammadex and the other half of the patients will receive neostigmine.

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Key information

About this study

Sugammadex and neostigmine are NMBD reversal agents. Neostigmine - an anticholinesterase is given to reverse NMBD; however reversal of NMBD with neostigmine may be associated with residual neuromuscular blockade in up to 64% patients postoperatively in the post anesthesia care unit. Even mild degrees of residual neuromuscular blockade can have serious clinical consequences in the postoperative period. The severity of OSA often worsens after surgery and patients with OSA are at increased risk for early respiratory complications after extubating and in the PACU. Morbid obesity is associated with critical respiratory complications in patients with OSA.

Sugammadex is a newer NMBD reversal agent that rapidly and completely reverses rocuronium. It is a modified gamma cyclodextrin that forms a complex with the neuromuscular blocking agent rocuronium. It reduces the amount of neuromuscular blocking agent available to bind to nicotinic cholinergic receptors in the neuromuscular junction. It has been shown to more rapidly reverse residual neuromuscular blockade than neostigmine in obese patients without obstructive sleep apnea (OSA).

This study will evaluate whether reversal of NMBD with sugammadex is associated with faster recovery than neostigmine resulting in faster discharge from the operating room (OR) in obese patients with OSA undergoing bariatric surgery. Half of the patients in the study will receive sugammadex and other half of the patients will receive neostigmine

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 18 years old
  • Diagnosed Obstructive Sleep Apnea patients by polysomnography
  • Scheduled elective bariatric surgery

Exclusion criteria

  • Age<18 years old
  • Allergy to rocuronium
  • Allergy to sugammadex
  • Allergy to neostigmine
  • Malignant hyperthermia
  • Hepatic insufficiency
  • Renal insufficiency
  • Neuromuscular Disease
  • Pregnancy

Treatment and study plan

Sugammadex Sodium

Drug

Sugammadex is a FDA approved newer NMBD reversal agent. But does not use in standard of care in most of institutions This study is designed to compare the impact of reversal of neuromuscular blockade with sugammadex vs. neostigmine on discharge time from the operating room in obese patients with OSA undergoing bariatric surgery

Other names: Bridion

Neostigmine

Drug

neostigmine is a FDA approved NMBD reversal drug, uses as standard care drug in most of the institutions. neostigmine use as active comparator to compare with investigational drug Sugammadex in the study.

Other names: prostigmin

Primary outcomes

  1. Time to Discharge From Operating Room

    Time frame: 15 minutes

    The time from study drug administration to discharge from operating room (OR).

Secondary outcomes

  1. Time the Patient Open Eyes to Command

    Time frame: 15 minutes

    Time from study drug administration to the patient open eyes to command.

Other outcomes

  1. Time to Extubation

    Time frame: 15 minutes

    Time from study drug administration to extubation

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Merck Canada Inc.

Registry information

Official study title

Impact of Sugammadex vs. Neostigmine Reversal on Post-Operative Recovery And Postoperative Complications In Patients With Obstructive Sleep Apnea Undergoing Bariatric Surgery: A Double-Blind, Randomized Controlled Trial

Acronym: Sugammadex

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 20, 2018
Registry last updated
Mar 20, 2025

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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