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临床试验/NCT06294639
NCT06294639尚未招募不适用

Median Effective Dose (ED50) of Esketamine Combined With Alfentanil for Children to Inhibit Body Movement During Laser Treatment for Facial Lesion

Air Force Military Medical University, China0 个研究点目标入组 40 人开始时间: 2024年3月27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
发起方
入组人数
40
主要终点
half effective dose of inhibition of body movement

研究概览

简要总结

There is limited research on the combined use of esketamine and alfentanil for anesthesia during facial laser treatment in pediatric patients, and the effective dosage of esketamine for inhibiting body movement remains unclear. We explore the effective dose of esketamine combined with alfentanil for the inhibition of body movement during facial laser treatment in pediatric patients.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Sequential
主要目的
Other
盲法
None

盲法说明

Esketamine will be prepared by an investigator who is not involved in anesthesia and outcome assessment. For all participants, esketamine will be diluted to the same volume.

入排标准

年龄范围
3 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • age between 3 years and 12 years old
  • patients scheduled for laser treatment of facial lesion

排除标准

  • patients with airway infection during the last 1 month
  • patients with cardiac or pulmonary disorder
  • patients with hepatic or renal disfunction
  • patients with neurologic or psychiatric disorder

研究组 & 干预措施

esketamine

Experimental

esketamine will be given intravenously

干预措施: Esketamine (Drug)

结局指标

主要结局

half effective dose of inhibition of body movement

时间窗: from injection of esketamine to start of laser treatment, in an average of 5 minutes

次要结局

  • number of patients with agitation during awake(from end of injection of esketamine to 30 minutes after laser treatment, in an average of 60 minutes)
  • number of patients with dizzy during awake(from end of injection of esketamine to 30 minutes after laser treatment, in an average of 60 minutes)
  • satisfaction score of the parents to the anesthesia(from end of laser treatment to discharge from the outpatient unit, in an average of 60 minutes)
  • number of patients with apnea during awake(from end of injection of esketamine to 30 minutes after laser treatment, in an average of 60 minutes)
  • number of patients with nausea and vomiting during awake(from end of injection of esketamine to 30 minutes after laser treatment, in an average of 60 minutes)

研究者

发起方
Air Force Military Medical University, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhihong LU

Associate professor

Air Force Military Medical University, China

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