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临床试验/NCT03807011
NCT03807011已完成不适用

The Effects of Remifentanil and Fentanyl on Emergence Agitation in Pediatric Strabismus Surgery

Yeungnam University College of Medicine2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2017年7月7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
90
试验地点
2
主要终点
incidence of postoperative agitation

研究概览

简要总结

This study was performed to assess the effects of continuous remifentanil infusion and single bolus administration of fentanyl on the incidence of emergence agitation in pediatrics undergoing strabismus surgery.

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
2 Years 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • patients undergoing elective subumbilical surgery,
  • physical status was American Society of Anesthesiologists (ASA) class 1 or 2

排除标准

  • history of airway problem,
  • upper respiratory tract infection within 2 weeks,
  • developmental delay,
  • neurological or psychological disease,
  • history of allergy to the drugs in our protocol were excluded in this study.

研究组 & 干预措施

fentanyl

Active Comparator

A bolus dose of fentanyl 2 μg/kg was administered intravenously at anesthetic induction

干预措施: fentanyl group (Drug)

remifentanil

Active Comparator

Remifentanil was continuously infused at a rate of 0.2 μg/kg/min from anesthetic induction to the end of surgery

干预措施: remifentanil group (Drug)

结局指标

主要结局

incidence of postoperative agitation

时间窗: 30 minutes in the recovery room

0=none; 1=occur

severity of postoperative agitation

时间窗: 30 minutes in the recovery room

Four-point agitation scale (0=calm; 1=not calm but could easily become calmed; 3=not easily calmed, moderately agitated and restless; 4=combative, excited, or disoriented)

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

研究点 (2)

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Emergence Agitation in Pediatric Strabismus Surgery | 临床试验