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临床试验/NCT06218680
NCT06218680尚未招募不适用

Efficacy of Low Dose Propofol Given at the End of Sevoflurane Anesthesia for Prevention of Emergence Agitation in Pediatric Patient Undergoing MRI Scan

Khon Kaen University1 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2024年1月20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
尚未招募
入组人数
134
试验地点
1
主要终点
incidence of emergence agitation

研究概览

简要总结

The goal of this clinical trial is to compare Efficacy of low dose propofol(0.5 mg/kg) vs placebo given at the end of sevoflurane anesthesia for prevention of emergence agitation in pediatric patient undergoing MRI scan. The main question it aims to answer is "Can low dose propofol reduce the incidence of emergence agitation after general anesthesia?" Participants will be given propofol 0.5 mg/kg or saline according to the allocated group at the completion of MRI scan

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 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age 2-8 years
  • ASA class I or II ,who schedule for MRI scan under sevoflurane anesthesia

排除标准

  • Developmental delay
  • Psychological and neurological disorders
  • Abnormal airway
  • Reactive airway disease
  • Allergy to propofol, egg product
  • Family history of malignant hyperthermia
  • Need iv sedative medication before induction

研究组 & 干预措施

group P

Experimental

Receive 0.5 mg/kg of propofol intravenously at end of sevoflurane anesthesia

干预措施: Propofol (Drug)

group S

Placebo Comparator

Receive saline intravenously at end of sevoflurane anesthesia

干预措施: Normal saline (Drug)

结局指标

主要结局

incidence of emergence agitation

时间窗: at 5,10,15,20,25,30 minutes after extubation

次要结局

  • Incidence of complication(2 hours after extubation)
  • Use of rescue medication(2 hours after extubation)
  • Length of stay in post anesthetic care unit(2 hours after extubation)
  • Emergence time(2 hours after extubation)

研究者

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

Santhita Pimonbut

Santhita Pimonbut

Khon Kaen University

研究点 (1)

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