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Completed

NCT Number: NCT07542015

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara City Hospital Bilkent

Ankara, 06800, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Propofol (Astra-Zeneca)

Drug

General anesthesia maintained with propofol-based technique during endovascular treatment of unruptured intracranial aneurysms

Propofol and Ketamine Mixture (Ketofol)

Drug

General anesthesia maintained with a combination of propofol and ketamine during endovascular treatment of unruptured intracranial aneurysms.

Primary outcomes

  1. Change in Optic Nerve Sheath Diameter (ONSD)

    Time frame: 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.

Secondary outcomes

  1. Mean Arterial Pressure (MAP)

    Time frame: Mean arterial pressure was recorded at predefined time points, including pre-induction, intraoperative period at 5-minute intervals, and recovery.

  2. Heart Rate

    Time frame: Heart rate was recorded at predefined time points, including pre-induction, intraoperative period at 5-minute intervals, and recovery.

  3. EtCO₂

    Time frame: End-tidal carbon dioxide levels were measured at predefined time points, including intraoperative period at 5-minute intervals.

  4. rSO₂

    Time frame: Regional cerebral oxygen saturation values were monitored continuously and recorded at predefined time points, including intraoperative period at 5-minute intervals.

  5. Bispectral Index (BIS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Collaborators

  • Uludag University

Registry information

Acronym: ONSD-KP

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Apr 21, 2026
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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