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临床试验/NCT02890186
NCT02890186Unknown4 期

Dual-loop Target Controlled Infusion for Coadministration of Propofol and Remifentanil Guided by Narcotrend Index in Anterior Cervical Decompression and Fusion With Internal Fixation

Guangzhou General Hospital of Guangzhou Military Command1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年4月1日最近更新:
适应症

试验速览

阶段
4 期
发起方
入组人数
60
试验地点
1
主要终点
the total dose of propofol and remifentanil

研究概览

简要总结

To investigate the application of closed target-controlled infusion(TCI) of propofol and remifentanil guided by Narcotrend index in the anterior cervical decompression and fusion with internal fixation surgery.

详细描述

Sixty patients scheduled for anterior cervical decompression and fusion with internal fixation surgery under general anesthesia were randomly divided into two groups:closed-loop (group A,n=30) and open-loop group(group B,n=30).The procedure during induction of anesthesia was same in two groups.In group A,if Narcotrend index(NI) fall down to 46 and keep more than 30 seconds,propofol and remifentanil were intravenously infused as feedback automatically to achieve the target NI of 26-46.However,the NI in group B was controlled manually.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
23 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA Ⅰ ~ Ⅱ women undergoing Laparoscopic surgery.
  • Written informed consent from the patient or the relatives of the participating patient.
  • BMI:18.0~25 kg/m2

排除标准

  • Mental illness can not match
  • epidural anesthesia contraindicated
  • People who have Slow-type arrhythmias
  • Chronic renal failure
  • Alcohol or drug abuse
  • Already taking gabapentin, pregabalin, benzodiazepin or antidepression drug

结局指标

主要结局

the total dose of propofol and remifentanil

时间窗: within three hours from the beginning to the end of the propofol and remifentanil

record the total dose of propofol and remifentanil from the beginning to the end of anesthesia

次要结局

未报告次要终点

研究者

发起方
Guangzhou General Hospital of Guangzhou Military Command
申办方类型
Other
责任方
Principal Investigator
主要研究者

bo xu

associate chief physician

Guangzhou General Hospital of Guangzhou Military Command

研究点 (1)

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