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临床试验/NCT05548998
NCT05548998已完成不适用

Effect of Low Fresh Gas Flow Volatile Anesthetics on Postoperative Neurocognitive Function in Elderly Patients

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization1 个研究点 分布在 1 个国家目标入组 230 人开始时间: 2019年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
230
试验地点
1
主要终点
Change from baseline in neurocognitive status on the 30 point MMSE at postoperative 24th hour

研究概览

简要总结

This study aims to investigate the effect of inhaled anesthetics with a low fresh gas flow on cognitive function of elderly patients undergoing elective surgery

详细描述

Geriatric patients scheduled to undergo surgery were tested with Mini Mental State Examination (MMSE) in the preoperative visit. MMSE was repeated postoperatively at the 6th hour, the 1st, 3rd, and 7th day. Visual analogue scale (VAS) test was performed simultaneously on the postoperative 6th hour, the 1st, 3rd, and 7th day. Two cohorts were created according to the amount of fresh gas flow (low flow vs high flow) in the maintenance phase of the inhalational anesthetic. MMSE scores were compared between cohorts and baseline. VAS scores were compared between cohorts.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Consenting to participate
  • Scheduled for surgery longer than 2 hours under GA
  • Able to read and write

排除标准

  • Refusing to participate
  • Existing visual impairment preventing the patient from reading or writing
  • Unable to read and write
  • Existing major neurocognitive disorder
  • Use of TIVA or regional techniques
  • Allergies to the volatile agents
  • Uncontrolled DM, acute alcohol intoxication
  • Conditions increasing tissue oxygen consumption (sepsis, thyrotoxicosis, etc.)
  • Anticipation/existence of major hemorrhage
  • Haemodynamic instability > 10 min or more than 5 times intraoperatively

结局指标

主要结局

Change from baseline in neurocognitive status on the 30 point MMSE at postoperative 24th hour

时间窗: Baseline and postoperative day 1

A Mini-Mental State Examination (MMSE) is a set of 11 questions that doctors and other healthcare professionals commonly use to check for cognitive impairment (problems with thinking, communication, understanding and memory).

次要结局

  • Change from baseline in neurocognitive status on the 30 point MMSE at postoperative 3rd day(Baseline and postoperative day 3)
  • Change from baseline in pain on the 10 point VAS scale at postoperative 6th hour(Baseline and postoperative hour 6)
  • Change from baseline in pain on the 10 point VAS scale at postoperative 3rd day(Baseline and postoperative day 3)
  • Change from baseline in neurocognitive status on the 30 point MMSE at postoperative 6th hour(Baseline and postoperative hour 6)
  • Change from baseline in neurocognitive status on the 30 point MMSE at postoperative 7th day(Baseline and postoperative day 7)
  • Change from baseline in pain on the 10 point VAS scale at postoperative 24th hour(Baseline and postoperative hour 24)
  • Change from baseline in pain on the 10 point VAS scale at postoperative 7th day(Baseline and postoperative day 7)

研究者

发起方
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
申办方类型
Other
责任方
Principal Investigator
主要研究者

Namigar Turgut

Professor

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

研究点 (1)

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