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临床试验/NCT03134547
NCT03134547已完成不适用

A Comparison of Postoperative Emergence Agitation by Sevoflurane for Intraoperative Sedation Associated With Caudal Block in Children: Randomised Comparison of Two Dose

Yeungnam University College of Medicine0 个研究点目标入组 40 人开始时间: 2016年6月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
40
主要终点
postoperative agitation score

研究概览

简要总结

This study was performed to compare the incidence of EA between two dose of sevoflurane for sedation with caudal block in children, and intended to find the optimal dose for prevention of sevoflurane induced emergence agitation

详细描述

After approval Institutional Review Board of our institute, informed consent was obtained from the parents of all pediatric patients. 40 children, aged up to 5 yr, undergoing elective subumbilical surgery were enrolled. Children with development delay, anxiety disorder, or a history of allergy to any study drugs, or severe systemic disease were excluded from this study. By a computer generated schedule, children were randomized to either the low dose (1.0%) end tidal concentration of sevoflurane group (Group LS) or the high dose (2.5%) end tidal concentration of sevoflurane group (Group HS). The patients were sedated with intravenous ketamine 2 mg/kg and midazolam 0.05 mg/kg at waiting room and checked the loss of response to verbal or gentle touch. Then the patients were into the operating room, applied electrocardiography (ECG), pulse oximetry, and noninvasive blood pressure. Respiratory rate and end tidal carbon dioxide (CO2) were monitored via face mask. After baseline vital signs were monitored, the patient was posed in lateral Sims position, and 1 ml/kg lidocaine 1% with 5 μg/ml epinephrine was injected into the caudal space using a 22 G needle under 100% oxygen with each sevoflurane concentration according to group through a face mask. All of these procedures were performed by one skilled anesthesiologist who blinded about the study group. After caudal block was performed, the patients were returned in supine position, and maintained on spontaneous ventilation under 100% oxygen and each sevoflurane concentration according to group via face mask to conduct sedation during operation. If oxygen saturation decreases lesser than 90% due to over sedation or breathe holding caused by procedural pain, ventilation was assisted. If analgesia was insufficient for operation, fentanyl 0.5-1 μg/kg was administrated properly.

In the postanesthetic care unit (PACU), the investigators observed EA episodes at 5 and 30 min after PACU arrival using Four-point agitation scale and Pediatric Anesthesia Emergence Delirium (PAED) scale, and if a total score of PAED scale is higher than 15, which is prescribed a severe agitation, and then propofol 0.5 mg/kg was administered. EA was considered as an Four-point agitation scale > 3 or PAED scale > 10.

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, Investigator, Outcomes Assessor)

入排标准

年龄范围
1 Year 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • patients undergoing elective subumbilical surgery, American society of anesthesiologist physical status classification 1

排除标准

  • Children with development delay, anxiety disorder, or a history of allergy to any study drugs, or severe systemic disease were excluded from this study.

研究组 & 干预措施

low volume volatile anesthetics

Active Comparator

1.0 % sevoflurane sedation via face mask , low dose sevoflurane group

干预措施: low dose sevoflurane group (Drug)

high volume volatile anesthetics

Active Comparator

2.5 % sevoflurane sedation via face mask, high dose sevoflurane group

干预措施: high dose sevoflurane group (Drug)

结局指标

主要结局

postoperative agitation score

时间窗: 30 minutes in the recovery room

Pediatric Anesthesia Emergence Delirium (PAED) scale

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eun Kyung Choi

Professor

Yeungnam University College of Medicine

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