Comparison of Desflurane, Sevoflurane, and Total Intravenous Anesthesia in Ear Surgery Under Controlled Hypotension (POCD-ENT)
Comparison of Desflurane, Sevoflurane, and Total Intravenous Anesthesia Methods in Terms of Postoperative Cognitive Dysfunction in Ear Surgery Performed Under Controlled Hypotension
研究概览
地位
详细说明
Controlled hypotension is commonly used in ear surgery to reduce intraoperative bleeding and improve the surgical field. However, the effects of different anesthetic maintenance techniques used during controlled hypotension on postoperative cognitive function remain unclear.
This prospective randomized study included adult patients undergoing elective ear surgery. Patients were randomly assigned to receive desflurane, sevoflurane, or total intravenous anesthesia for maintenance of anesthesia under controlled hypotension.
The primary objective of the study was to evaluate postoperative cognitive dysfunction. Secondary objectives included comparison of intraoperative hemodynamic stability, cerebral oxygenation, and perioperative clinical outcomes among the three anesthesia techniques.
Hemodynamic parameters and cerebral oxygen saturation were recorded at predefined time points during the intraoperative period. Postoperative cognitive function was assessed using standardized cognitive evaluation methods.
The findings of this study aim to contribute to the selection of optimal anesthetic techniques in ear surgery performed under controlled hypotension.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Istanbul
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Istanbul、Istanbul、土耳其（türkiye）、34865
- Kartal Dr. Lutfi Kirdar City Hospital
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Patients aged 18 years and older
- ASA physical status I-II
- Scheduled for elective tympanoplasty, mastoidectomy, or tympanomastoidectomy under general anesthesia
- Provided written informed consent
Exclusion Criteria:
- Patients with known neurological or psychiatric disorders affecting cognitive function
- Pre-existing cognitive impairment
- Severe hepatic or renal insufficiency
- History of alcohol or substance abuse
- Inability to complete cognitive function tests
- Emergency surgery
- Refusal to participate in the study
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Desflurane-Remifentanil Group
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Used for maintenance of anesthesia.
Used for maintenance of anesthesia.
|
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实验性的：Sevoflurane-Remifentanil Group
Patients received general anesthesia with sevoflurane for maintenance and remifentanil infusion.
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Used for maintenance of anesthesia.
Used for maintenance of anesthesia.
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实验性的：Total Intravenous Anesthesia (Propofol-Remifentanil) Group
Patients received total intravenous anesthesia with propofol and remifentanil infusion.
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Used for maintenance of anesthesia.
Used for maintenance of anesthesia.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Postoperative cognitive function (POCD)
大体时间：Preoperative baseline and postoperative day 7
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Postoperative cognitive function was evaluated using standardized neurocognitive tests before surgery and on postoperative day 7. Changes from baseline were analyzed to assess postoperative cognitive dysfunction.
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Preoperative baseline and postoperative day 7
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Intraoperative cerebral oxygen saturation (rSO2)
大体时间：Preoperative baseline (T0); 5, 15, 30, 45, and 60 minutes after intubation (T1-T5); and 5 and 15 minutes after extubation (T6-T7).
|
Regional cerebral oxygen saturation (rSO2) was continuously monitored intraoperatively using near-infrared spectroscopy (NIRS) and compared between groups at predefined time points.
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Preoperative baseline (T0); 5, 15, 30, 45, and 60 minutes after intubation (T1-T5); and 5 and 15 minutes after extubation (T6-T7).
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Mean Arterial Pressure
大体时间：Preoperative baseline (T0); 5, 15, 30, 45, and 60 minutes after intubation (T1-T5); and 5 and 15 minutes after extubation (T6-T7).
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Mean arterial pressure (MAP) was recorded intraoperatively at predefined time points and compared between the three anesthesia groups.
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Preoperative baseline (T0); 5, 15, 30, 45, and 60 minutes after intubation (T1-T5); and 5 and 15 minutes after extubation (T6-T7).
|
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Arterial Partial Pressure of Oxygen
大体时间：15 minutes (T2) and 60 minutes (T5) after intubation.
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Arterial partial pressure of oxygen (PaO₂) was measured intraoperatively at predefined time points and compared between the three anesthesia groups.
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15 minutes (T2) and 60 minutes (T5) after intubation.
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Heart Rate
大体时间：Preoperative baseline (T0); 5, 15, 30, 45, and 60 minutes after intubation (T1-T5); and 5 and 15 minutes after extubation (T6-T7).
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Heart rate (HR) was recorded intraoperatively at predefined time points and compared between the three anesthesia groups.
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Preoperative baseline (T0); 5, 15, 30, 45, and 60 minutes after intubation (T1-T5); and 5 and 15 minutes after extubation (T6-T7).
|
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Arterial Partial Pressure of Carbon Dioxide
大体时间：15 minutes (T2) and 60 minutes (T5) after intubation.
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Arterial partial pressure of carbon dioxide (PaCO₂) was measured intraoperatively at predefined time points and compared between the three anesthesia groups.
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15 minutes (T2) and 60 minutes (T5) after intubation.
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Blood Lactate Level
大体时间：15 minutes (T2) and 60 minutes (T5) after intubation.
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Blood lactate level was measured intraoperatively at predefined time points and compared between the three anesthesia groups.
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15 minutes (T2) and 60 minutes (T5) after intubation.
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- KDLH-POCD-ENT-2024
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
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