Effect of Sugammadex vs. Neostigmine/Glycopyrrolate on Pediatric Emergence Delirium in Sevoflurane-rocuronium Anesthesia
Condition: Emergence Delirium
MeSH terms: Delirium; Emergence Delirium
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to investigate the effect of sugammadex vs. a conventional
      acetylcholinesterase inhibitor, neostigmine on emergence delirium (ED) during
      sevoflurane-rocuronium anesthesia in pediatric patients Additionally, the efficacy features
      of sugammadex compared to neostigmine will be examined by measuring the time from start of
      administration of reversal agents to recovery of train-of-four (TOF) ratio to 0.7, 0.8, and
      0.9.

      Although the etiology of ED remains unclear, a sense of suffocation or breathing difficulty
      during emergence from anesthesia has been suggested as a possible cause. Thus, reversal of
      neuromuscular blockade with sugammadex in pediatric patients maintained with
      sevoflurane-rocuronium anesthesia may decrease ED due to its faster reversal of neuromuscular
      blockade and decreased possibility of residual blockade.
    

Detailed description: 
      Emergence delirium (ED) is a postanesthetic phenomenon that develops in the early phase of
      general anesthesia recovery, (usually within the first 30 minutes,) and is defined as "a
      disturbance in a child's awareness of and attention to his/her environment with
      disorientation and perceptual alterations including hypersensitivity to stimuli and
      hyperactive motor behavior" . Children are often irritable, uncompromising, uncooperative,
      incoherent, and inconsolably crying, moaning, kicking, or thrashing. The incidence of ED
      varies from 2 to 80%, occurring more frequently in preschool boys. Risk factors also include
      the following: sevoflurane or desflurane anesthesia; ear, nose and throat surgery;
      preoperative anxiety. ED is known to increase physical, psychological, and financial burdens
      in the postanesthesia care unit, which emphasizes the importance of its prevention.

      The aim of this study is to investigate the effect of sugammadex vs. a conventional
      acetylcholinesterase inhibitor, neostigmine on emergence delirium (ED) during
      sevoflurane-rocuronium anesthesia in pediatric patients Additionally, the efficacy features
      of sugammadex compared to neostigmine will be examined by measuring the time from start of
      administration of reversal agents to recovery of TOF ratio to 0.7, 0.8, and 0.9.

      Although the etiology of ED remains unclear, a sense of suffocation or breathing difficulty
      during emergence from anesthesia has been suggested as a possible cause. Thus, reversal of
      neuromuscular blockade with sugammadex in pediatric patients maintained with
      sevoflurane-rocuronium anesthesia may decrease ED due to its faster reversal of neuromuscular
      blockade and decreased possibility of residual blockade.
    

Intervention name(s): Sugammadex Injection [Bridion]; Neostigmine+Glycopyrronium
Intervention type(s): Drug; Drug
Intervention description(s): Return to T2 point (two contractions) on TOF device is replied by iv 2 mg/kg sugammadex administration, contained in a blinded syringe.; Return to T2 point (two contractions) on TOF device is replied by iv 0.06 mg/kg neostigmine and 0.005 mg/kg glycopyrrolate administration, contained in a blinded syringe.
Other intervention name(s): Sugammadex; Neostigmine
Intervention MeSH terms: Glycopyrrolate; Neostigmine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: emergence delirium; tonsillectomy