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临床试验/NCT07525648
NCT07525648
招募中
不适用

Comparison of the Effects of Sevoflurane and Desflurane Used for Anesthesia Maintenance on Optic Nerve Sheath Diameter in the Trendelenburg Position

Medipol University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年4月15日最近更新:

概览

阶段
不适用
状态
招募中
发起方
Medipol University
入组人数
60
试验地点
1
主要终点
Optic Nerve Sheath Diameter (ONSD)

概览

简要总结

Laparoscopic surgeries require pneumoperitoneum and Trendelenburg position, which may lead to increased intracranial pressure (ICP).

Optic nerve sheath diameter (ONSD) measurement via ultrasound is a non-invasive method to evaluate ICP.

This prospective study aims to compare the effects of sevoflurane and desflurane on ONSD in patients undergoing laparoscopic hysterectomy and bilateral oophorectomy in the Trendelenburg position.

详细描述

The primary objective of this study is to compare the ONSD values measured by ultrasound between the sevoflurane and desflurane groups.

The secondary objective is to evaluate the relationship between ONSD changes, hemodynamic parameters, and postoperative neurological complications.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients planned for laparoscopic hysterectomy bilateral oophorectomy surgery under general anesthesia.

排除标准

  • Patients receiving beta-blocker or diuretic treatment.
  • Patients with severe heart failure.
  • Patients diagnosed with diabetes with ocular or neurological complications.
  • Patients who have undergone cardiac surgery, eye surgery, brain surgery, or thoracic surgery.
  • Patients with a history of hydrocephalus, glaucoma, intracranial mass, and stroke.

研究组 & 干预措施

Group 1 (Sevo)

Active Comparator

干预措施: Sevoflurane (Drug)

Group 2 (Des)

Active Comparator

干预措施: Desflurane (Drug)

结局指标

主要结局

Optic Nerve Sheath Diameter (ONSD)

时间窗: Intraoperative (approx. 2-4 hours): immediately and 10 min post-intubation, 10 and 60 min post-Trendelenburg/pneumoperitoneum, 10 min post-neutral position."

Three measurements will be taken in the transverse and sagittal planes for each eye and the average will be calculated.

次要结局

  • Heart Rate (HR)(Intraoperative (approx. 2-4 hours): immediately and 10 min post-intubation, 10 and 60 min post-Trendelenburg/pneumoperitoneum, 10 min post-neutral position.")
  • Mean Arterial Pressure (MAP)(Intraoperative (approx. 2-4 hours): immediately and 10 min post-intubation, 10 and 60 min post-Trendelenburg/pneumoperitoneum, 10 min post-neutral position.")
  • Peripheral Oxygen Saturation (SpO2)(Intraoperative (approx. 2-4 hours): immediately and 10 min post-intubation, 10 and 60 min post-Trendelenburg/pneumoperitoneum, 10 min post-neutral position.")
  • End-tidal Carbon Dioxide (EtCO2)(Intraoperative (approx. 2-4 hours): immediately and 10 min post-intubation, 10 and 60 min post-Trendelenburg/pneumoperitoneum, 10 min post-neutral position.")
  • Arterial pH(Intraoperative (approx. 2-4 hours): immediately and 10 min post-intubation, 10 and 60 min post-Trendelenburg/pneumoperitoneum, 10 min post-neutral position.")
  • Partial Pressure of Carbon Dioxide (pCO2)(Intraoperative (approx. 2-4 hours): immediately and 10 min post-intubation, 10 and 60 min post-Trendelenburg/pneumoperitoneum, 10 min post-neutral position.")

研究者

发起方
Medipol University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Burak Omur

assistant professor

Medipol University

研究点 (1)

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