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临床试验/NCT03165396
NCT03165396Unknown不适用

The Appropriate Compatibility of Propofol and Sevoflurane for Orthopaedic Surgery of Patients With Mild Cognitive Impairment

The Third Central Clinical College of Tianjin Medical University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年11月10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
发起方
入组人数
100
试验地点
1
主要终点
Evidence of clinically cognitive function decline :Apolipoprotein J(ApoJ)

研究概览

简要总结

According to the inclusion and exclusion criteria, elderly patients undergoing elective orthopedic surgery were randomly divided into four groups. The different combinations of propofol and sevoflurane were used in the four groups: 1 day before surgery, after patients become wide-awake, and 3 days, 7 days, and 3 months after surgery, the patient's cognitive function was evaluated using a professional cognitive scale and other indicators. Finally, statistical analysis.

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
Double (Participant, Care Provider)

入排标准

年龄范围
50 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Elective orthopaedic surgery
  • American Society of Anesthesiologists physical status: II

排除标准

  • Neurological diseases that may affect cognitive function (e.g., subdural hematoma)
  • Hypothyroidism
  • Alcoholic dementia

研究组 & 干预措施

Propofol

Experimental

administrated Target Controlled Infusion (TCI)of propofol (Cp 2.0~2.5μg/ml )for maintaining

干预措施: Propofol (Drug)

1.2 μg/ml Propofol

Experimental

administrated Target Controlled Infusion (TCI)of propofol (Cp 1.2 μg/ml )combined with appropriate sevoflurane for maintaining

干预措施: Propofol (Drug)

1.2 μg/ml Propofol

Experimental

administrated Target Controlled Infusion (TCI)of propofol (Cp 1.2 μg/ml )combined with appropriate sevoflurane for maintaining

干预措施: Sevoflurane (Drug)

0.6 μg/ml Propofol

Experimental

administrated Target Controlled Infusion (TCI)of propofol (Cp 0.6 μg/ml )combined with appropriate sevoflurane for maintaining

干预措施: Propofol (Drug)

0.6 μg/ml Propofol

Experimental

administrated Target Controlled Infusion (TCI)of propofol (Cp 0.6 μg/ml )combined with appropriate sevoflurane for maintaining

干预措施: Sevoflurane (Drug)

Sevoflurane

Experimental

administrated 1.3 minimum alveolar concentration(MAC ) sevoflurane for maintaining

干预措施: Sevoflurane (Drug)

结局指标

主要结局

Evidence of clinically cognitive function decline :Apolipoprotein J(ApoJ)

时间窗: Change from Baseline Apolipoprotein J at 7 days

Measurement by ELISA kit

次要结局

  • Mini mental Examination(MMSE)(preoperative 24 hours , 7 days post surgery)
  • Montreal Cognitive Assessment(MoCA)(preoperative 24 hours ,7 days post surgery)
  • Evidence of clinically cognitive function decline :Soluble CD14(sCD14)(Change from Baseline Soluble CD14 at 7 days)

研究者

发起方
The Third Central Clinical College of Tianjin Medical University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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