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临床试验/NCT07062601
NCT07062601尚未招募不适用

Effect of Etomidate and Esketamine on Postoperative Pain After Tonsillectomy Undergoing Children With General Anesthesia

Anqing Municipal Hospital0 个研究点目标入组 64 人开始时间: 2025年7月10日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
64
主要终点
The face, legs, arms, crying, consolability (FLACC) pain scale

研究概览

简要总结

Objective: To explore the effect of etomidate and esketamine on postoperative pain after tonsillectomy in children.

Methods: Investigators enrolled 64 children with American Society of Anesthesiologists (ASA) physical status I and II, aged 2-10 years, and scheduled for elective undergoing tonsillectomy with general anesthesia. All the enrolled patients were randomly divided into etomidate and fentanyl group (Group A) and etomidate and esketamine group (Group B). In the etomidate-fentanyl group (group A), 0.3 mg/kg etomidate and 4 µg/kg fentanyl were given at the induction of anesthesia, followed by continuous infusion of propofol at 4-12 mg/kg/h and remifentanil at 3-6 µg/kg/h until the end of the surgery, respectively; in the etomidate-esketamine group (group B), induction of anesthesia with 0.3 mg/kg etomidate and 0.5 mg/kg esketamine , followed by continuous infusion of propofol at 4-12 mg/kg/h and remifentanil at 3-6 µg/kg/h until the end of the operation. Anesthesiologists who were unaware of the grouping recorded the FlACC Pain Scale at 2 h, 8 h, and 24 h after 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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
2 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children who underwent elective tonsillectomy
  • Aged 2-10 years old
  • ASA class I-II

排除标准

  • Children with hepatic or renal dysfunction
  • Those with increased intracranial or intra-ocular pressure
  • Children with schizophrenia, bipolar disorder, and any other psychiatric condition
  • Children with preexisting chronic pain
  • Children with preoperative combined sinus bradycardia or atrioventricular block

研究组 & 干预措施

Etomidate and fentanyl group

Experimental

In the etomidate-fentanyl group (group A), 0.3 mg/kg etomidate and 4 µg/kg fentanyl were given at the induction of anesthesia, followed by continuous infusion of propofol at 4-12 mg/kg/h and remifentanil at 3-6 µg/kg/h until the end of the surgery, respectively

干预措施: Etomidate and fentanyl group (Drug)

Etomidate and esketamine group

Experimental

In the etomidate-esketamine group (group B), induction of anesthesia with 0.3 mg/kg etomidate and 0.5 mg/kg esketamine , followed by continuous infusion of propofol at 4-12 mg/kg/h and remifentanil at 3-6 µg/kg/h until the end of the operation

干预措施: Etomidate and esketamine group (Drug)

结局指标

主要结局

The face, legs, arms, crying, consolability (FLACC) pain scale

时间窗: at 2 hours, 8 hours, and 24 hours after surgery

Anesthesiologists who were unaware of the grouping recorded the face, legs, arms, crying, consolability (FLACC) pain scale at 2 hours, 8 hours, and 24 hours after surgery

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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