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

Obstructive Sleep Apnea Clinical Trial

— Sugammadex  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03679611
• Other study ID #: 18-5629
• Status: Completed
• Phase: Phase 4
• Start date: January 14, 2019
• Est. completion date: October 26, 2021

Study information

• Verified date: October 2022
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Sugammadex or neostigmine are given at the end of the surgery to reverse neuro muscular blocking drugs. 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.

Description:

Sugammadex and neostigmine are Neuromuscular Blocking Drugs(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 extubation 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 26, 2021
• Est. primary completion date: October 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Drug:
• Sugammadex Sodium
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
• Neostigmine
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.

Locations

Country	Name	City	State
Canada	Toronto Western Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Merck Canada Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time to extubation	Time from study drug administration to extubation	15 minutes
Primary	time to discharge from operating room	Time from study drug administration to discharge from operating room	15 minutes
Secondary	Time the patient open eyes to command	Time from study drug administration to the patient open eyes to command.	15 minutes