Unruptured Intracranial AneurysmONSD-KPNCT07542015
Comparison of Propofol and Propofol-Ketamine Anesthesia on Optic Nerve Sheath Diameter in Endovascular Cerebral Aneurysm Procedures
An observational study of Unruptured Intracranial Aneurysm and Cerebral Aneurysm Unruptured, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Unruptured Intracranial Aneurysm, Cerebral Aneurysm Unruptured, Cerebral Aneurysms
- What is being tested?
- Propofol (Astra-Zeneca) and Propofol and Ketamine Mixture (Ketofol)
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2025to 1 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Propofol (Astra-Zeneca), Propofol and Ketamine Mixture (Ketofol)
- Keywords
- Optic nerve sheath diameter, Intracranial pressure, Cerebral aneurysm, propofol, ketamine, neuroanesthesia
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Propofol Anesthesia | Patients who underwent elective endovascular treatment of unruptured intracranial aneurysms under propofol-based general anesthesia Receives: 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 Receives: Drug: Propofol and Ketamine Mixture (Ketofol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From pre-induction (baseline) to end of procedure
Secondary outcomes (5)
Mean Arterial Pressure (MAP)
Measured: Mean arterial pressure was recorded at predefined time points, including pre-induction, intraoperative period at 5-minute intervals, and recovery.
Heart Rate
Measured: Heart rate was recorded at predefined time points, including pre-induction, intraoperative period at 5-minute intervals, and recovery.
EtCO₂
Measured: End-tidal carbon dioxide levels were measured at predefined time points, including intraoperative period at 5-minute intervals.
rSO₂
Measured: Regional cerebral oxygen saturation values were monitored continuously and recorded at predefined time points, including intraoperative period at 5-minute intervals.
Bispectral Index (BIS)
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start15 Jun 2025
- Primary completion20 Dec 2025
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unruptured Intracranial AneurysmStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Collaborators
- Uludag University
- Responsible party
- Principal investigator, Eda Şahin, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07542015
- Sponsor's protocol ID
- (TABED) 1-25-1345
- Acronym
- ONSD-KP
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Sahin E, Gokbulut Ozaslan N, Erdem G, Ozkaya G. Comparison of propofol and propofol-ketamine anesthesia on optic nerve sheath diameter in endovascular cerebral aneurysm procedures: a prospective randomized study. BMC Anesthesiol. 2026 Aug 11;26(1):550. doi: 10.1186/s12871-026-04158-3.
PubMed 42698093
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Propofol and Propofol-Ketamine Anesthesia on Optic Nerve Sheath Diameter in Endovascular Cerebral Aneurysm Procedures
- ClinicalTrials.gov ID
- NCT07542015
- Acronym / sponsor ID
- ONSD-KP / (TABED) 1-25-1345
- Keywords
- Optic nerve sheath diameter, Intracranial pressure, Cerebral aneurysm, propofol, ketamine, neuroanesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Collaborators
- Uludag University
- Study start
- 15 Jun 2025 (actual)
- Primary completion
- 20 Dec 2025 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol Anesthesia | – | Drug: Propofol (Astra-Zeneca)Patients who underwent elective endovascular treatment of unruptured intracranial aneurysms under propofol-based general anesthesia |
| Propofol-Ketamine Anesthesia | – | Drug: Propofol and Ketamine Mixture (Ketofol)Patients who underwent elective endovascular treatment of unruptured intracranial aneurysms under general anesthesia with a combination of propofol and ketamine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propofol (Astra-Zeneca)General anesthesia maintained with propofol-based technique during endovascular treatment of unruptured intracranial aneurysms | Drug | Propofol Anesthesia |
| Propofol and Ketamine Mixture (Ketofol)General anesthesia maintained with a combination of propofol and ketamine during endovascular treatment of unruptured intracranial aneurysms. | Drug | Propofol-Ketamine Anesthesia |
Primary outcome
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.
5 secondary outcomes
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.
Heart Rate
Time frame: 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.
rSO₂
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Derived from this study: PubMed 42698093Sahin E, Gokbulut Ozaslan N, Erdem G, Ozkaya G. Comparison of propofol and propofol-ketamine anesthesia on optic nerve sheath diameter in endovascular cerebral aneurysm procedures: a prospective randomized study. BMC Anesthesiol. 2026 Aug 11;26(1):550. doi: 10.1186/s12871-026-04158-3.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unruptured Intracranial Aneurysm and Cerebral Aneurysm Unruptured, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Optic Nerve Sheath Diameter (ONSD) (time frame: From pre-induction (baseline) to end of procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07542015, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.