Impact of Sugammadex vs. Neostigmine Reversal on Post-Operative Recovery and Complications
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      Sugammadex or neostigmine are given at the end of the surgery to reverse neuro muscular
      blocking drugs. 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 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
    

Intervention name(s): Sugammadex Sodium; Neostigmine
Intervention type(s): Drug; Drug
Intervention description(s): 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; 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 intervention name(s): Bridion; prostigmin
Intervention MeSH terms: Neostigmine
Allocation: Randomized
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)
Primary purpose: Treatment
Keywords: Recovery time; reversal of neuromuscular blockers; obstructive sleep apnea; morbid obesity; bariatric surgery