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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03679611
Recruitment Status : Recruiting
First Posted : September 20, 2018
Last Update Posted : November 13, 2020
Sponsor:
Collaborator:
Merck Canada Inc.
Information provided by (Responsible Party):
Jean Wong, University Health Network, Toronto

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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.
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 : January 14, 2019
Estimated Primary Completion Date : May 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


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 Name: 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 Name: prostigmin




Primary Outcome Measures :
  1. time to discharge from operating room [ Time Frame: 15 minutes ]
    Time from study drug administration to discharge from operating room


Secondary Outcome Measures :
  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 Outcome Measures:
  1. Time to extubation [ Time Frame: 15 minutes ]
    Time from study drug administration to extubation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03679611


Contacts
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Contact: Jean Wong, MD 416-603-5800 ext 3635 jean.wong@uhn.ca
Contact: Nishanthi Liyanage, MD 416-603-5800 ext 3959 nishanthi.liyanage@uhnresearch.ca

Locations
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Canada, Ontario
Toronto Western Hospital Recruiting
Toronto, Ontario, Canada, M5T 2S8
Contact: Jean Wong, MD    416 790 6910    jean.wong@uhn.ca   
Contact: Nishanthi Liyanage, MD    416 603 5800 ext 3959    nishanthi.liyanage@uhnresearch.ca   
Principal Investigator: Jean Wong, MD         
Sponsors and Collaborators
University Health Network, Toronto
Merck Canada Inc.
Investigators
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Principal Investigator: Jean Wong, MD University Health Network, Toronto Western Hospital
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Responsible Party: Jean Wong, Staff Anesthesiologist, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03679611    
Other Study ID Numbers: 18-5629
First Posted: September 20, 2018    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: November 2020
Individual Participant Data (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jean Wong, University Health Network, Toronto:
Recovery time
reversal of neuromuscular blockers
obstructive sleep apnea
morbid obesity
bariatric surgery
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Neostigmine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents