Effects of Standard and Modified Z-Trendelenburg Positions on Cerebral Oxygenation and Optic Nerve Sheath Diameter (MOD-TREND)
Comparison of the Effects of Standard Trendelenburg and Modified Z Trendelenburg Positions on Cerebral Oxygenation (NIRS) and Optic Nerve Sheath Diameter in Laparoscopic Gynecological Cases
研究概览
详细说明
Laparoscopic surgeries frequently require patients to be placed in a steep Trendelenburg position with pneumoperitoneum to provide optimal surgical exposure. However, this combination induces significant physiological alterations, most notably an increase in intracranial pressure (ICP) and a potential compromise in cerebral venous drainage and regional cerebral oxygen saturation (rSO2). Non-invasive monitoring techniques, such as measuring the optic nerve sheath diameter (ONSD) via ultrasonography, provide reliable, real-time estimates of ICP changes. Additionally, Near-Infrared Spectroscopy (NIRS) allows for the continuous monitoring of cerebral oxygenation.
This prospective clinical study is designed to evaluate and compare the cerebral and hemodynamic impacts of the standard straight Trendelenburg position versus a modified Z-Trendelenburg position. Participants scheduled for elective laparoscopic procedures will be divided into specific positioning groups. Hemodynamic parameters, NIRS values, and ONSD measurements will be recorded at predefined time points throughout the surgery: at baseline, post-induction, after the establishment of pneumoperitoneum and positioning, at specific intervals during the surgery, and post-operatively in the recovery room. The primary hypothesis is that the modified Z-Trendelenburg position will attenuate the rise in ICP (reflected by a smaller increase in ONSD) and provide better cerebral oxygenation stability compared to the traditional standard position.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Ankara
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Ankara、Ankara、土耳其(türkiye)、06010
- Ankara Etlik 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
取样方法
研究人群
描述
Inclusion Criteria:
Patients aged between 18 and 70 years
American Society of Anesthesiologists (ASA) physical status I or II
Scheduled for elective laparoscopic surgery requiring Trendelenburg position
Provided written informed consent
Exclusion Criteria:
Patient refusal to participate
History of severe cerebrovascular disease
Known increased intracranial pressure
Pre-existing ocular pathology that could affect optic nerve sheath diameter (ONSD) measurements (e.g., glaucoma, optic neuritis, ocular trauma)
Severe cardiovascular or pulmonary disease Body Mass Index (BMI) greater than 35 kg/m^2 Pregnancy
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Standard Trendelenburg Cohort
Patients undergoing elective laparoscopic surgery placed in the standard straight Trendelenburg position.
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Placement of the patient in the traditional straight head-down tilt position required for laparoscopic surgical access and pneumoperitoneum
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Modified Z-Trendelenburg Cohort
Patients undergoing elective laparoscopic surgery placed in the modified Z-Trendelenburg position (head-down tilt combined with leg flexion).
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Placement of the patient in a modified head-down tilt position combined with leg flexion
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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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Change in Regional Cerebral Oxygen Saturation (rSO2)
大体时间:Baseline (before anesthesia induction), at 10, 45, 60, and 90 minutes after establishing pneumoperitoneum and surgical positioning, and 10 minutes after returning to the supine position.
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Regional cerebral oxygen saturation (rSO2) will be measured bilaterally using Near-Infrared Spectroscopy (NIRS) sensors placed on the patient's forehead.
This non-invasive monitoring will be used to evaluate cerebral oxygenation changes during different surgical positions and pneumoperitoneum.
Values will be recorded as percentages (%).
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Baseline (before anesthesia induction), at 10, 45, 60, and 90 minutes after establishing pneumoperitoneum and surgical positioning, and 10 minutes after returning to the supine position.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Mean Arterial Pressure (MAP)
大体时间:Baseline ( 10 minutes after anesthesia induction), at 10,45, 60, and 90 minutes after establishing pneumoperitoneum and surgical positioning, and 10 minutes after returning to the supine position.
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Mean Arterial Pressure (MAP) will be continuously monitored and recorded to evaluate the cardiovascular effects of the pneumoperitoneum and modified positioning.
Values will be reported in mmHg.
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Baseline ( 10 minutes after anesthesia induction), at 10,45, 60, and 90 minutes after establishing pneumoperitoneum and surgical positioning, and 10 minutes after returning to the supine position.
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Change in Optic Nerve Sheath Diameter (ONSD)
大体时间:Baseline ( 10 minutes after anesthesia induction), at 10, 45, 60, and 90 minutes after establishing pneumoperitoneum and surgical positioning, and 10 minutes after returning to the supine position.
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Intracranial pressure changes will be evaluated indirectly by measuring the optic nerve sheath diameter (ONSD) using ocular ultrasonography.
Measurements will be taken bilaterally and recorded in millimeters (mm).
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Baseline ( 10 minutes after anesthesia induction), at 10, 45, 60, and 90 minutes after establishing pneumoperitoneum and surgical positioning, and 10 minutes after returning to the supine position.
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Change in Peak Airway Pressure (Ppeak)
大体时间:Baseline (10 minutes after anesthesia induction), at 10,45, 60, and 90 minutes after establishing pneumoperitoneum and surgical positioning, and 10 minutes after returning to the supine posi
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Peak airway pressure will be monitored continuously and recorded to evaluate the effects of pneumoperitoneum and different surgical positions on respiratory mechanics.
Values will be reported in centimeters of water (cmH2O).
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Baseline (10 minutes after anesthesia induction), at 10,45, 60, and 90 minutes after establishing pneumoperitoneum and surgical positioning, and 10 minutes after returning to the supine posi
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Change in End-tidal Carbon Dioxide (EtCO2)
大体时间:Baseline (10 minutes after anesthesia induction), at 10, 45, 60, and 90 minutes after establishing pneumoperitoneum and surgical positioning, and 10 minutes after returning to the supine positi
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End-tidal carbon dioxide levels will be monitored continuously via capnography to evaluate ventilation status during pneumoperitoneum and different positioning.
Values will be reported in millimeters of mercury (mmHg).
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Baseline (10 minutes after anesthesia induction), at 10, 45, 60, and 90 minutes after establishing pneumoperitoneum and surgical positioning, and 10 minutes after returning to the supine positi
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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
其他研究编号
- AEŞH-EK-2026-048
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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