跳至主要内容
临床试验/NCT03010098
NCT03010098Unknown4 期

The Effect on the Older's Cognition of Dual-loop Target Controlled Infusion Guided by Narcotrend Index

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: 2017年1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
MMSE scores

研究概览

简要总结

To investigate the effect on older's cognition of the application of closed target-controlled infusion(TCI) of propofol and remifentanil guided by Narcotrend index .

详细描述

Two hundreds of patients scheduled for surgery under general anesthesia were randomly divided into two groups:closed-loop (group A,n=100) and open-loop group(group B,n=100).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.Taking an exam of MMSE before and after the surgery which measures if the older's cognition changed. Furthermore.we will measure the levels of protein S100beta and NSE.

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
60 Years 至 80 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 dru

结局指标

主要结局

MMSE scores

时间窗: up to 1 week

The Mini-Mental State Examination (MMSE) or Folstein test is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment.It is commonly used in medicine and allied health to screen for dementia. It is also used to estimate the severity and progression of cognitive impairment and to follow the course of cognitive changes in an individual over time; thus making it an effective way to document an individual's response to treatment. The MMSE's purpose has been not, on its own, to provide a diagnosis for any particular nosological entity.We measure the patient before the operation and the first/third/seventh day after the operation.

次要结局

  • protein s100beta(up to 24 hours)

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)

Loading locations...

相似试验