Obstructive Sleep Apnea
Conditions
Keywords
Recovery time, reversal of neuromuscular blockers (NMB), obstructive sleep apnea, morbid obesity, bariatric surgery
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
Interventions
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
DRUGNeostigmine
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.
Sponsors
Merck Canada Inc.
University Health Network, Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, 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.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Discharge From Operating Room | 15 minutes | The time from study drug administration to discharge from operating room (OR). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time the Patient Open Eyes to Command | 15 minutes | Time from study drug administration to the patient open eyes to command. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time to Extubation | 15 minutes | Time from study drug administration to extubation |
Countries
Canada
Participant flow
Recruitment details
120 patients were enrolled from January 14, 2019 to October 26, 2021. Study coordinators screened 237 patients for eligibility in the pre-operative and bariatric clinics at Toronto Western Hospital, University Health Network- a Bariatric Centre of Excellence located in Toronto, Ontario, Canada. Consenting patients were ≥18 years with OSA diagnosed by polysomnography for elective bariatric surgery under general anesthesia. Randomization was 1:1 into 2 groups of sugammadex vs. neostigmine.
Pre-assignment details
A total of 237 patients were screened for eligibility in our study. 108 were excluded for not meeting study criteria. 9 were excluded for reasons like a hold on surgeries due to the coronavirus disease (COVID-19) pandemic or cancellations, unavailability of investigators on scheduled surgery days, etc. 120 patients were enrolled on the study and were subsequently randomized 1:1 into 2 groups of 60 patients each, given the study drug, and followed-up as per the study protocol.
Participants by arm
| Arm | Count |
|---|---|
| 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
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 | 60 |
| 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
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. | 60 |
| Total | 120 |
Baseline characteristics
| Characteristic | Standard Drug Arm | Total | Interventional Arm |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 60 Participants | 120 Participants | 60 Participants |
| Age, Continuous | 51.00 Years | 50.50 Years | 49.50 Years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Canada | 60 participants | 120 participants | 60 participants |
| Sex: Female, Male Female | 43 Participants | 88 Participants | 45 Participants |
| Sex: Female, Male Male | 17 Participants | 32 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 60 |
| other Total, other adverse events | 0 / 60 | 0 / 60 |
| serious Total, serious adverse events | 1 / 60 | 1 / 60 |
Outcome results
Primary
Time to Discharge From Operating Room
The time from study drug administration to discharge from operating room (OR).
Time frame: 15 minutes
Population: Same as baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Interventional Arm | Time to Discharge From Operating Room | 13.0 Minutes |
| Standard Drug Arm | Time to Discharge From Operating Room | 13.5 Minutes |
Secondary
Time the Patient Open Eyes to Command
Time from study drug administration to the patient open eyes to command.
Time frame: 15 minutes
Population: Same as baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Interventional Arm | Time the Patient Open Eyes to Command | 6.00 Minutes |
| Standard Drug Arm | Time the Patient Open Eyes to Command | 7.00 Minutes |
Other Pre-specified
Time to Extubation
Time from study drug administration to extubation
Time frame: 15 minutes
Population: Same as baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Interventional Arm | Time to Extubation | 7.00 Minutes |
| Standard Drug Arm | Time to Extubation | 8.00 Minutes |