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临床试验/NCT07212543
NCT07212543进行中(未招募)不适用

The Effects of Different Low-Flow Desflurane Anesthesia Strategies on Bispectral Index and Postoperative Cognitive Functions in Patients Undergoing Major Abdominal Surgery

Dolunay ARIK1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2025年5月15日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
72
试验地点
1
主要终点
Change from Baseline in Mini-Mental State Examination (MMSE) Score Postoperatively

研究概览

简要总结

This study investigates the effects of low-flow desflurane anesthesia in adult patients undergoing major abdominal surgery. The researchers will examine whether different low-flow strategies:

Cause differences in the Bispectral Index (BIS), which measures brain activity during anesthesia, Affect postoperative cognitive functions such as memory and attention.

Participants will:

Receive desflurane anesthesia during surgery, Have anesthesia delivered at different low-flow rates, Have their BIS values monitored throughout the operation, Complete tests after surgery to evaluate their cognitive functions.

This research will help determine the safety of different low-flow strategies and their impact on patients' cognitive recovery after surgery.

详细描述

This prospective observational study is designed to evaluate the effects of different low-flow desflurane anesthesia strategies on intraoperative anesthetic depth, measured by the Bispectral Index (BIS), and on postoperative cognitive functions in patients undergoing major abdominal surgery.

Patients will receive desflurane anesthesia delivered at different low-flow rates. Throughout surgery, BIS values will be continuously monitored to assess the depth of anesthesia. Postoperatively, standardized cognitive function tests will be performed at predetermined time points to evaluate potential cognitive impairment or recovery. The study aims to clarify whether the choice of low-flow strategy influences short-term postoperative neurocognitive outcomes.

Quality assurance and data management procedures:

Data collection will be conducted using standardized electronic case report forms (eCRFs).

All collected data will undergo range and consistency checks against predefined rules.

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
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 18-75 years
  • ASA physical status I-III
  • Scheduled for elective major abdominal surgery
  • Provided written informed consent
  • Normal preoperative neurocognitive function

排除标准

  • History of neurological or psychiatric disorders
  • History of cognitive impairment
  • Diagnosed hepatic or renal insufficiency
  • Presence of other systemic diseases contraindicating anesthesia

结局指标

主要结局

Change from Baseline in Mini-Mental State Examination (MMSE) Score Postoperatively

时间窗: From baseline (preoperative assessment, within 24 hours before surgery) to postoperative assessments at 24 hours and 7 days after surgery

Measure: Change in cognitive function assessed by the Mini-Mental State Examination (MMSE) Time Frame: From baseline (preoperative assessment) to postoperative assessment (within 24 hours after surgery) Description: The MMSE will be used to evaluate changes in cognitive function in patients receiving desflurane anesthesia at different low-flow rates. The primary endpoint is the difference between preoperative and postoperative MMSE scores.

次要结局

未报告次要终点

研究者

发起方
Dolunay ARIK
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dolunay ARIK

Resident Doctor (Anesthesiology)

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

研究点 (1)

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