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

April 14, 2026 updated by: Eda Şahin, Ankara City Hospital Bilkent
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

46

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients aged 18-75 years with unruptured intracranial aneurysms scheduled for elective endovascular treatment under general anesthesia at Ankara City Hospital Bilkent.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Propofol Anesthesia
Patients who underwent elective endovascular treatment of unruptured intracranial aneurysms under propofol-based general anesthesia
Drug: Propofol (Astra-Zeneca)
General anesthesia maintained with propofol-based technique during endovascular treatment of unruptured intracranial aneurysms
Propofol-Ketamine Anesthesia
Patients who underwent elective endovascular treatment of unruptured intracranial aneurysms under general anesthesia with a combination of propofol and ketamine
Drug: Propofol and Ketamine Mixture (Ketofol)
General anesthesia maintained with a combination of propofol and ketamine during endovascular treatment of unruptured intracranial aneurysms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From pre-induction (baseline) to end of procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
Mean arterial pressure was recorded at predefined time points, including pre-induction, intraoperative period at 5-minute intervals, and recovery.
Heart Rate
Time Frame: Heart rate was recorded at predefined time points, including pre-induction, intraoperative period at 5-minute intervals, and recovery.
Heart rate was recorded at predefined time points, including pre-induction, intraoperative period at 5-minute intervals, and recovery.
EtCO₂
Time Frame: End-tidal carbon dioxide levels were measured at predefined time points, including intraoperative period at 5-minute intervals.
End-tidal carbon dioxide levels were measured at predefined time points, including intraoperative period at 5-minute intervals.
rSO₂
Time Frame: Regional cerebral oxygen saturation values were monitored continuously and recorded at predefined time points, including intraoperative period at 5-minute intervals.
Regional cerebral oxygen saturation values were monitored continuously and recorded at predefined time points, including intraoperative period at 5-minute intervals.
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara City Hospital Bilkent

Collaborators

Uludag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2025

Primary Completion (Actual)

December 20, 2025

Study Completion (Actual)

January 1, 2026

Study Registration Dates

First Submitted

April 14, 2026

First Submitted That Met QC Criteria

April 14, 2026

First Posted (Actual)

April 21, 2026

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • (TABED) 1-25-1345

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be made publicly available due to ethical and institutional restrictions, as well as patient confidentiality considerations. The study was conducted as a single-center academic thesis, and data sharing was not specified in the informed consent.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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