Clinical trial NCT03679611: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obstructive Sleep Apnea
Keywords: Recovery time
reversal of neuromuscular blockers (NMB)
obstructive sleep apnea
morbid obesity
bariatric surgery
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Merck Canada Inc.
First posted: 2018-09-20
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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 neuromuscular blocking drugs (NMBD) with sugammadex or neostigmine.
Primary purpose: TREATMENT

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.

Detailed description: Sugammadex and neostigmine are 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 extubating 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

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

Primary outcomes:
measure: Time to Discharge From Operating Room
timeFrame: 15 minutes
Secondary outcomes:
measure: Time the Patient Open Eyes to Command
timeFrame: 15 minutes
Other outcomes:
measure: Time to Extubation
timeFrame: 15 minutes
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto Western Hospital
name: Jean Wong, MD
role: PRINCIPAL_INVESTIGATOR
References: