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临床试验/NCT03179293
NCT03179293已完成4 期

Transition to Propofol After Sevoflurane Anaesthesia to Prevent Emergence Agitation in Genito-urinary Paediatric Surgeries

Assiut University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2017年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
70
试验地点
1
主要终点
Emergence Agitation

研究概览

简要总结

The aim of this randomized double-blinded study is to determine whether transition to propofol for 3 min at the end of sevoflurane anaesthesia reduces the incidence of EA in children undergoing genito-urinary paediatric surgeries.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
3 Years 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children Aged 3 - 8 years
  • ASA (I - II)
  • Genito-urinary Surgeries: hernia, varicocele, etc.

排除标准

  • Patients or parental refusal
  • Allergy to Propofol or egg products; or a family history of malignant hyperthermia
  • Operating time more than 60 minutes
  • Performance of any other procedure under the same anaesthetic
  • Presence of co-morbidities or congenital anomalies
  • mental disease, neurologic disease, treatment with sedatives, full stomach, or indication for rapid sequence induction.

研究组 & 干预措施

Propofol

Active Comparator

propofol 1 mg/kg IV bolus will be given to the patient with a further 2 mg/kg administered manually over the next 3 min prior to the patient leaving the OR

干预措施: Propofol (Drug)

Control

Placebo Comparator

Normal saline will be administered IV over the next 3 min prior to the patient leaving the OR

干预措施: Normal saline (Drug)

结局指标

主要结局

Emergence Agitation

时间窗: 30 min after emergence

The incidence of EA according to the Paediatric Emergence Anaesthesia Delirium (PAED) scale (defined as a score \>12 at any time in the 30 min after emergence )

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

Mostafa Samy Abbas

Lecturer

Assiut University

研究点 (1)

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