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

NCT03679611 | Completed Phase 4 Results

• 1 other identifier: 18-5629
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obstructive Sleep Apnea

Keywords

Recovery time; reversal of neuromuscular blockers (NMB); obstructive sleep apnea; morbid obesity; bariatric surgery

Outcome Measures

Primary Outcomes (1)

• Time to Discharge From Operating Room

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

  15 minutes

Secondary Outcomes (1)

• Time the Patient Open Eyes to Command

  15 minutes

Other Outcomes (1)

• Time to Extubation

  15 minutes

Study Arms (2)

Interventional Arm

EXPERIMENTAL

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

Standard drug Arm

ACTIVE COMPARATOR

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

Interventions

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

Also known as: Bridion

Interventional Arm

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.

Also known as: prostigmin

Standard drug Arm

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Merck Canada Inc.: collaborator

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Obesity, Morbid

Interventions

Sugammadex; Neostigmine

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates; Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds

Limitations and Caveats

1. . USFDA recommends neostigmine 0.03 mg/kg to 0.07 mg/kg. We used 2.5 mg for NMBD reversal. A less-than-recommended dose being used in our patients. However, providers had the option of giving a supplemental dose of neostigmine or sugammadex if they felt it was clinically indicated, with a very low rate of redosing 2. . Lack of continuous quantitative neuromuscular monitoring and ability to detect residual NMBD at the time of extubating 3. . Conservative use of muscle relaxants by our providers

Results Point of Contact

• Title: Dr. Jean Wong, MD, FRCPC.
• Organization: Department of Anesthesiology and Pain Medicine, Toronto Western Hospital, University Health Network

tojean.wong@uhn.ca

416-603-5800

Study Officials

• Jean Wong, MD

  University Health Network, Toronto Western Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All study investigators, research coordinator, patients, surgeons, anesthesiologists, health care personnel will be blinded to the treatment arm allocation in the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Anesthesiologist

Model Details: 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 neuromuscular blocking drugs (NMBD) with sugammadex or neostigmine.

Study Record Dates

• First Submitted: September 13, 2018
• First Posted: September 20, 2018
• Study Start: January 14, 2019
• Primary Completion: October 26, 2021
• Study Completion: October 26, 2021
• Last Updated: March 20, 2025
• Results First Posted: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)