Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Merck Canada Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Discharge From Operating Room | The time from study drug administration to discharge from operating room (OR). | 15 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Time the Patient Open Eyes to Command | Time from study drug administration to the patient open eyes to command. | 15 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Extubation | Time from study drug administration to extubation | 15 minutes |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jean Wong, MD | University Health Network, Toronto Western Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toronto Western Hospital | Toronto | Ontario | M5T 2S8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38848257 | Derived | Ajetunmobi O, Wong D, Perlas A, Rajaleelan W, Wang S, Huszti E, Jackson T, Chung F, Wong J. Impact of Sugammadex Versus Neostigmine Reversal on Postoperative Recovery Time in Patients With Obstructive Sleep Apnea Undergoing Bariatric Surgery: A Double-Blind, Randomized Controlled Trial. Anesth Analg. 2025 Mar 1;140(3):568-576. doi: 10.1213/ANE.0000000000007013. Epub 2024 Jun 7. |
Not provided
Not provided
Research study results will be presented for publication in peer reviewed journals by the protocol.
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 an FDA approved newer neuromuscular blocking drug (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 |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Study population were morbidly obese adult (≥18 years) patients with OSA diagnosed by polysomnography for elective bariatric surgery under general anesthesia at Toronto Western Hospital- University Health Network, who were able to give consent. They were randomized 1:1 for reversal of NMBDs with sugammadex or neostigmine.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Discharge From Operating Room | The time from study drug administration to discharge from operating room (OR). | Same as baseline | Posted | Median | Inter-Quartile Range | Minutes | 15 minutes |
|
Adverse event data was collected when available through the course of study completion for each participant, an average of 1 day.
Standard definitions were used by the study for adverse events.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain | Musculoskeletal and connective tissue disorders | Standard vocabulary | Systematic Assessment | Spontaneous resolution/self limiting. Less than 24 hours. Assessed as mild and unrelated. |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jean Wong, MD, FRCPC. | Department of Anesthesiology and Pain Medicine, Toronto Western Hospital, University Health Network | 416-603-5800 | 3635 | tojean.wong@uhn.ca |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 1, 2019 | Aug 16, 2024 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077122 | Sugammadex |
| D009388 | Neostigmine |
| ID | Term |
|---|---|
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
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.
Not provided
Not provided
All study investigators, research coordinator, patients, surgeons, anesthesiologists, health care personnel will be blinded to the treatment arm allocation in the study.
|
|
| 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. |
|
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Age, Continuous | Median | Inter-Quartile Range | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 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. |
|
|
| Secondary | Time the Patient Open Eyes to Command | Time from study drug administration to the patient open eyes to command. | Same as baseline | Posted | Median | Inter-Quartile Range | Minutes | 15 minutes |
|
|
|
| Other Pre-specified | Time to Extubation | Time from study drug administration to extubation | Same as baseline | Posted | Median | Inter-Quartile Range | Minutes | 15 minutes |
|
|
|
| 0 |
| 60 |
| 1 |
| 60 |
| 0 |
| 60 |
| EG001 | 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. | 0 | 60 | 1 | 60 | 0 | 60 |
|
| Cellulitis left leg | Musculoskeletal and connective tissue disorders | Standard vocabulary | Systematic Assessment | Resolved. 10 days. Assessed as moderate and unrelated |
|
Not provided
Not provided
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003912 |
| Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D050338 | Phenylammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009861 | Onium Compounds |