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临床试验/NCT07266727
NCT07266727已完成不适用

Anesthetic Agent Titration With EEG Wave Analysis: Does it Improve Postoperative Recovery?

Marmara University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年3月4日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
1
主要终点
Postoperative Recovery Quality

研究概览

简要总结

Several studied shown that when general anesthesia is applied under BIS guidance, anesthetic doses are reduced. Additionally it has been found that the risk of postoperative delirium (POD) is reduced and postoperative recovery is accelerated compared to deeper general anesthesia. Current guidelines recommend EEG-based monitoring techniques to prevent postoperative neurocognitive disorders. In clinical practice anesthetic depth is assessed by the patient's autonomic responses to surgical stimulation (pupil diameter, tear, blood pressure and heart rate increase, etc.), the amount of anesthetic gas measured from the expiratory air, and the interpretation of EEG waves and numerical values calculated from these waves (bispactral index, entropy, patient safety index, etc.). The doses of intravenous anesthetic agents used for anesthesia induction are traditionally determined according to body weight. If general anesthetic doses cannot be titrated appropriately for the patients, especially in the elderly and fragile patient group, serious hemodynamic fluctuations may occur during anesthesia induction. The aim of this study is to investigate whether induction and maintenance of anesthesia using the Kugler EEG Analysis method would improve the quality of postoperative recovery in patients aged 65 years and older.

详细描述

Several studied shown that when general anesthesia is applied under BIS guidance, anesthetic doses are reduced. Additionally it has been found that the risk of postoperative delirium (POD) is reduced and postoperative recovery is accelerated compared to deeper general anesthesia. Current guidelines recommend EEG-based monitoring techniques to prevent postoperative neurocognitive disorders. In clinical practice anesthetic depth is assessed by the patient's autonomic responses to surgical stimulation (pupil diameter, tear, blood pressure and heart rate increase, etc.), the amount of anesthetic gas measured from the expiratory air, and the interpretation of EEG waves and numerical values calculated from these waves (bispactral index, entropy, patient safety index, etc.). The doses of intravenous anesthetic agents used for anesthesia induction are traditionally determined according to body weight. If general anesthetic doses cannot be titrated appropriately for the patients, especially in the elderly and fragile patient group, serious hemodynamic fluctuations may occur during anesthesia induction. The aim of this study is to investigate whether induction and maintenance of anesthesia using the Kugler EEG Analysis method would improve the quality of postoperative recovery in patients aged 65 years and older.

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

  • Patients aged 65 and over
  • Elective patients undergoing general anesthesia
  • EEG monitoring

排除标准

  • Pediatric patients
  • Patients not giving written consent
  • Emergency cases
  • History of seizure
  • Intracranial surgeries
  • Alcohol and substance addiction
  • Severe cognitive impairment (dementia, Alzheimer's)

结局指标

主要结局

Postoperative Recovery Quality

时间窗: 24 hours

Data of QoR-15 score in the preoperative period and at the 24th hour postoperatively The 15-item Quality of Recovery (QoR-15) score is a patient-reported outcome measure assessing postoperative recovery. Scores range from 0 to 150, with higher scores indicating better quality of recovery.

次要结局

  • Postoperative Delirium Evaluation(48 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Şeyma Çelik

Principal Investigator

Marmara University

研究点 (1)

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