Effect of Sugammadex vs. Neostigmine/Glycopyrrolate on Pediatric Emergence Delirium in Sevoflurane-rocuronium Anesthesia

Phase 4

Completed

Conditions: Emergence Delirium

Interventions: Drug: Sugammadex Injection [Bridion]
Drug: Neostigmine+Glycopyrronium

Registration Number: NCT03229486

Lead Sponsor: Pusan National University Yangsan Hospital

Brief 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 40

Inclusion Criteria

American Society of Anesthesiologist (ASA) physical status I or II, preschool children scheduled for an elective tonsillectomy with or without adenoidectomy will be included in the study.

Exclusion Criteria

Patients will be excluded in cases of emergency surgery, developmental, psychological, cognitive or communication disorders, known or suspected neuromuscular disorders that may impair neuromuscular blockade, significant renal or hepatic dysfunction, coagulation disorders, family history of malignant hyperthermia, allergy to any of the drugs included in the study protocol, or usage of medication known to interact with rocuronium or sugammadex.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sugammadex Injection [Bridion]	Sugammadex Injection [Bridion]	reversal of neuromuscular blockade with sugammadex
Neostigmine+Glycopyrronium	Neostigmine+Glycopyrronium	reversal of neuromuscular blockade with neostigmine \& glycopyrrolate

Primary Outcome Measures

Name	Time	Method
Pediatric Anesthesia Emergence Delirium Score	within 30 minutes after arrival at post-anesthesia care unit (PACU)	Maximum Pediatric Anesthesia Emergence Delirium (PAED) score after arrival in the PACU.Higher values represent more emergence delirium (worse) PAED Score is represented with total PAED score summed up of subscales. The total score is reported and it ranges from 0 to 20. Higher score means worse state.

Secondary Outcome Measures

Name	Time	Method
Time Recovery of TOF Ratio to 0.8	Time from the start of administration of reversal agents to recovery of the TOF ratio to 0.8, assessed up to 60 minutes	Time from the start of administration of reversal agents to recovery of the TOF ratio to 0.8
Time Recovery of TOF Ratio to 0.7	Time from the start of administration of reversal agents to recovery of the TOF ratio to 0.7, assessed up to 60 minutes	Time from the start of administration of reversal agents to recovery of the TOF ratio to 0.7
Time to Awakening	time from administration of reversal agent to time of eye opening or child showing purposeful movements, assessed up to 60 minutes	time from administration of reversal agent to time of eye opening or child showing purposeful movement
Time to Regular Breathing	time from administration of reversal agent to time of deep, regular breathing, assessed up to 60 minutes	time from administration of reversal agent to time of deep, regular breathing
Time to Extubation	time from administration of reversal agent to time of tracheal extubation, assessed up to 60 minutes	time from administration of reversal agent to time of tracheal extubation
Time Recovery of TOF Ratio to 0.9	Time from the start of administration of reversal agents to recovery of the TOF ratio to 0.9, assessed up to 60 minutes	Time from the start of administration of reversal agents to recovery of the TOF ratio to 0.9