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临床试验/NCT04194294
NCT04194294已完成4 期

Intravenous Lidocaine Reduces Remifentanil and Propofol Requirements Without Altering the Electrical Stapedial Reflex Threshold in Pediatric Cochlear Implants

Wahba bakhet0 个研究点目标入组 70 人开始时间: 2015年8月18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
发起方
入组人数
70
主要终点
Remifentanil consumption

研究概览

简要总结

The stapedius reflex protects the ear from the loud noise. The measurement of the intraoperative electrically evoked stapedial reflex threshold (ESRT) during pediatric cochlear implants (CIs) is used to confirm that the implant is functioning correctly and determine the maximum comfortable level . Total intravenous anesthesia (TIVA) with propofol and remifentanil is frequently used for pediatric CIs as it does not suppress the ESRT. However, high doses of remifentanil exacerbates postoperative pain and increased opioid consumption.

详细描述

Total intravenous anesthesia (TIVA) with propofol and remifentanil is frequently used for pediatric CIs as it does not suppress the ESRT. However, high doses of remifentanil exacerbates postoperative pain and increased opioid consumption.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
6 Months 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • ASA I and II children

排除标准

  • uncontrolled hypertension, diabetes mellitus, liver disease, kidney disease, heart disease, allergy to lidocaine

研究组 & 干预措施

Na CL 0.9%

Active Comparator

group C

干预措施: Na CL 0.9% (Other)

Liocaine

Active Comparator

Group Lid

干预措施: Lidocaine (Drug)

结局指标

主要结局

Remifentanil consumption

时间窗: at the end of the surgey

microgram per kilogram

次要结局

  • ESRT responses(After insertion of the electrode and after reversal of any residual muscle relaxant (TOF response > 0.9),)

研究者

发起方
Wahba bakhet
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Wahba bakhet

Lectrure of anesthesia

Ain Shams University

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