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

NCT07542015 | Completed

• 1 other identifier: (TABED) 1-25-1345
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Unruptured Intracranial Aneurysm; Cerebral Aneurysm Unruptured; Cerebral Aneurysms

Keywords

Optic nerve sheath diameter; Intracranial pressure; Cerebral aneurysm; propofol; ketamine; neuroanesthesia

Outcome Measures

Primary Outcomes (1)

• Change in Optic Nerve Sheath Diameter (ONSD)

  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 Outcomes (5)

• 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.

Study Arms (2)

Propofol Anesthesia

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

Drug: Propofol (Astra-Zeneca)

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)

Interventions

Propofol (Astra-Zeneca) DRUG

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

Propofol Anesthesia

Propofol and Ketamine Mixture (Ketofol) DRUG

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

Propofol-Ketamine Anesthesia

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead
• Uludag University: collaborator

Study Sites (1)

Ankara City Hospital Bilkent

Ankara, 06800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Intracranial Aneurysm

Interventions

Propofol

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician in Anesthesiology

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: April 21, 2026
• Study Start: June 15, 2025
• Primary Completion: December 20, 2025
• Study Completion: January 1, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)