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

Sponsor

University Health Network, Toronto (Other)

Overall Status

Recruiting

CT.gov ID

NCT03679611

Collaborator

Merck Canada Inc. (Industry)

120

Enrollment

Location

Arms

36.6

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Obstructive Sleep Apnea	Drug: Sugammadex Sodium Drug: Neostigmine	Phase 4

Detailed 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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This study is a prospective, double-blinded randomized controlled superiority trial with two parallel groups. Randomization will be performed with a 1:1 allocation into reversal of NMBD with sugammadex or neostigmine.This study is a prospective, double-blinded randomized controlled superiority trial with two parallel groups. Randomization will be performed with a 1:1 allocation into reversal of NMBD with sugammadex or neostigmine.

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

All study investigators, research coordinator, patients, surgeons, anesthesiologists, health care personnel will be blinded to the treatment arm allocation in the study.

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 14, 2019

Anticipated Primary Completion Date :

Dec 30, 2021

Anticipated Study Completion Date :

Jan 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Interventional Arm Interventional Arm will receive sugammadex sodium 2 mg/kg actual body weight, At the end of surgery Sugammadex will be administered when the TOF reveals at least 2 responses	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 Other Names: Bridion
Active Comparator: Standard drug Arm standard drug Arm will receive neostigmine 2.5 mg and glycopyrrolate 0.4 mg, At the end of surgery neostigmine and glycopyrrolate will be administered when the TOF reveals at least 2 responses	Drug: 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. Other Names: prostigmin

Arm

Intervention/Treatment

Experimental: Interventional Arm

Interventional Arm will receive sugammadex sodium 2 mg/kg actual body weight, At the end of surgery Sugammadex will be administered when the TOF reveals at least 2 responses

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

Other Names:

Bridion

Active Comparator: Standard drug Arm

standard drug Arm will receive neostigmine 2.5 mg and glycopyrrolate 0.4 mg, At the end of surgery neostigmine and glycopyrrolate will be administered when the TOF reveals at least 2 responses

Drug: 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.

Other Names:

prostigmin

Outcome Measures

Primary Outcome Measures

time to discharge from operating room [15 minutes]
Time from study drug administration to discharge from operating room

Secondary Outcome Measures

Time the patient open eyes to command [15 minutes]
Time from study drug administration to the patient open eyes to command.

Other Outcome Measures

Time to extubation [15 minutes]
Time from study drug administration to extubation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Toronto Western Hospital	Toronto	Ontario	Canada	M5T 2S8

Sponsors and Collaborators

University Health Network, Toronto
Merck Canada Inc.

Investigators

Principal Investigator: Jean Wong, MD, University Health Network, Toronto Western Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jean Wong, Staff Anesthesiologist, University Health Network, Toronto

ClinicalTrials.gov Identifier:

NCT03679611

Other Study ID Numbers:

18-5629

First Posted:

Sep 20, 2018

Last Update Posted:

Oct 28, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Jean Wong, Staff Anesthesiologist, University Health Network, Toronto

Recovery time

reversal of neuromuscular blockers

obstructive sleep apnea

morbid obesity

bariatric surgery

Additional relevant MeSH terms:

Apnea

Sleep Apnea Syndromes

Sleep Apnea, Obstructive

Neostigmine

Study Results

No Results Posted as of Oct 28, 2021