Emergence Delirium Clinical Trial
Official title:
A Prospective, Double-blind, Randomized Study to Investigate the Effect of Sugammadex vs. Neostigmine/Glycopyrrolate on Emergence Delirium During Sevoflurane-rocuronium Anesthesia in Pediatric Patients
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.
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.
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