Impact of Sugammadex vs. Neostigmine Reversal on Post-Operative Recovery and Complications (Sugammadex)
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|ClinicalTrials.gov Identifier: NCT03679611|
Recruitment Status : Completed
First Posted : September 20, 2018
Last Update Posted : October 14, 2022
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea||Drug: Sugammadex Sodium Drug: Neostigmine||Phase 4|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|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.|
|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|
|Actual Primary Completion Date :||October 26, 2021|
|Actual Study Completion Date :||October 26, 2021|
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
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
- time to discharge from operating room [ Time Frame: 15 minutes ]Time from study drug administration to discharge from operating room
- Time the patient open eyes to command [ Time Frame: 15 minutes ]Time from study drug administration to the patient open eyes to command.
- Time to extubation [ Time Frame: 15 minutes ]Time from study drug administration to extubation
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
|Toronto Western Hospital|
|Toronto, Ontario, Canada, M5T 2S8|
|Principal Investigator:||Jean Wong, MD||University Health Network, Toronto Western Hospital|