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临床试验/NCT07542015
NCT07542015已完成不适用

Comparison of Propofol and Propofol-Ketamine Anesthesia on Optic Nerve Sheath Diameter in Endovascular Cerebral Aneurysm Procedures

Ankara City Hospital Bilkent1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2025年6月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
46
试验地点
1
主要终点
Change in Optic Nerve Sheath Diameter (ONSD)

研究概览

简要总结

This study aimed to compare the effects of propofol-based anesthesia and propofol-ketamine anesthesia on optic nerve sheath diameter (ONSD) in patients undergoing elective endovascular treatment of unruptured intracranial aneurysms. ONSD, measured using ultrasonography, is a non-invasive surrogate marker of intracranial pressure. In addition, intraoperative hemodynamic parameters, cerebral oxygenation, and anesthetic requirements were evaluated to assess the safety and physiological impact of the two anesthesia techniques.

详细描述

Endovascular treatment of unruptured intracranial aneurysms requires anesthetic strategies that maintain cerebral perfusion and hemodynamic stability while minimizing increases in intracranial pressure. Optic nerve sheath diameter (ONSD) measurement using ultrasonography is a widely accepted non-invasive method for assessing intracranial pressure changes.

This study included adult patients who underwent elective endovascular treatment for unruptured intracranial aneurysms. Patients were managed with either propofol-based anesthesia or a combination of propofol and ketamine according to routine clinical practice.

ONSD measurements were performed at predefined time points during the perioperative period, and changes in ONSD were analyzed. In addition, intraoperative mean arterial pressure, heart rate, end-tidal carbon dioxide levels, regional cerebral oxygen saturation, vasopressor requirements, and total anesthetic consumption were recorded.

The primary objective of the study was to compare changes in ONSD between the two anesthesia techniques. Secondary objectives included evaluation of hemodynamic stability, cerebral oxygenation, and anesthetic requirements.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

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

  • Age between 18 and 75 years
  • Patients scheduled for elective endovascular treatment of unruptured intracranial aneurysms
  • ASA physical status I-III
  • Glasgow Coma Scale score of 15
  • Ability to read and write and provide written informed consent

排除标准

  • Age under 18 or over 75 years
  • ASA physical status IV or higher
  • History of ocular disease or previous eye surgery
  • Presence of giant aneurysm
  • Increased intracranial pressure
  • Coronary artery disease
  • Psychiatric or neurological disorders interfering with consent or assessment
  • Emergency surgical indication

研究组 & 干预措施

Propofol Anesthesia

Patients who underwent elective endovascular treatment of unruptured intracranial aneurysms under propofol-based general anesthesia

干预措施: Propofol (Astra-Zeneca) (Drug)

Propofol-Ketamine Anesthesia

Patients who underwent elective endovascular treatment of unruptured intracranial aneurysms under general anesthesia with a combination of propofol and ketamine

干预措施: Propofol and Ketamine Mixture (Ketofol) (Drug)

结局指标

主要结局

Change in Optic Nerve Sheath Diameter (ONSD)

时间窗: From pre-induction (baseline) to end of procedure

Optic nerve sheath diameter (ONSD) was measured using ultrasonography at five predefined time points: pre-induction (baseline), pre-intubation, post-intubation, end of procedure, and recovery period. The primary outcome was the change in ONSD from baseline to the end of the procedure. Measurements were obtained bilaterally at 3 mm behind the globe and averaged.

次要结局

  • Mean Arterial Pressure (MAP)(Mean arterial pressure was recorded at predefined time points, including pre-induction, intraoperative period at 5-minute intervals, and recovery.)
  • Heart Rate(Heart rate was recorded at predefined time points, including pre-induction, intraoperative period at 5-minute intervals, and recovery.)
  • EtCO₂(End-tidal carbon dioxide levels were measured at predefined time points, including intraoperative period at 5-minute intervals.)
  • rSO₂(Regional cerebral oxygen saturation values were monitored continuously and recorded at predefined time points, including intraoperative period at 5-minute intervals.)
  • Bispectral Index (BIS)(Bispectral index values were recorded to monitor depth of anesthesia at predefined time points, including pre-induction, intraoperative period at 5-minute intervals, and recovery.)

研究者

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

Eda Şahin

Resident Physician in Anesthesiology

Ankara City Hospital Bilkent

研究点 (1)

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