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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pediatric Anesthesia Emergence Delirium Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 2 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Sugammadex Injection [Bridion]
reversal of neuromuscular blockade with sugammadex
干预措施: Sugammadex Injection [Bridion] (Drug)
Neostigmine+Glycopyrronium
reversal of neuromuscular blockade with neostigmine & glycopyrrolate
干预措施: Neostigmine+Glycopyrronium (Drug)
结局指标
主要结局
Pediatric Anesthesia Emergence Delirium Score
时间窗: 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.
次要结局
- 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 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 to Awakening(time from administration of reversal agent to time of eye opening or child showing purposeful movements, assessed up to 60 minutes)
- Time to Regular Breathing(time from administration of reversal agent to time of deep, regular breathing, assessed up to 60 minutes)
- Time to Extubation(time from administration of reversal agent to time of tracheal extubation, assessed up to 60 minutes)
- 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)
研究者
Tae-Kyun Kim
Associate professor
Pusan National University Yangsan Hospital