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

• ClinicalTrials.gov Identifier: NCT03679611
• Recruitment Status: Completed
• First Posted: September 20, 2018
• Last Update Posted: October 14, 2022
• Sponsor: University Health Network, Toronto
• Collaborator: Merck Canada Inc.
• Information provided by (Responsible Party): Jean Wong, University Health Network, Toronto

Tracking Information

• First Submitted Date: September 13, 2018
• First Posted Date: September 20, 2018
• Last Update Posted Date: October 14, 2022
• Actual Study Start Date: January 14, 2019
• Actual Primary Completion Date: October 26, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 19, 2018)

time to discharge from operating room [ Time Frame: 15 minutes ]

Time from study drug administration to discharge from operating room

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 19, 2018)

Time the patient open eyes to command [ Time Frame: 15 minutes ]

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

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: September 19, 2018)

Time to extubation [ Time Frame: 15 minutes ]

Time from study drug administration to extubation

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Impact of Sugammadex vs. Neostigmine Reversal on Post-Operative Recovery and Complications
• 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
• 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.

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 Type: Interventional
• Study Phase: Phase 4

Study Design

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.

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

• Condition: Obstructive Sleep Apnea

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
  Other Name: Bridion
• 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 Name: prostigmin

Study Arms

• 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
  Intervention: Drug: Sugammadex Sodium
• 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
  Intervention: Drug: Neostigmine

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 19, 2018): 120
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: October 26, 2021
• Actual Primary Completion Date: October 26, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 90 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT03679611
• Other Study ID Numbers: 18-5629
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: Research study results will be presented for publication in peer reviewed journals by the protocol.

• Current Responsible Party: Jean Wong, University Health Network, Toronto
• Original Responsible Party: Same as current
• Current Study Sponsor: University Health Network, Toronto
• Original Study Sponsor: Same as current
• Collaborators: Merck Canada Inc.

Investigators

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

• PRS Account: University Health Network, Toronto
• Verification Date: October 2022