Procedural SedationNCT07882524
Effects of Sedation Agents on Optic Nerve Sheath Diameter
An observational study of Procedural Sedation, run by Alanya Alaaddin Keykubat University at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study aims to evaluate the acute effects of ketamine and propofol sedation on optic nerve sheath diameter (ONSD) in adult patients undergoing procedural sedation in the emergency department. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Procedural Sedation
- Type of treatment
- Injection or infusion
- How many people
- 73 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2023to 31 May 2025
- How long will I take part?
- 1 Day
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This prospective, observational, single-center cohort study was conducted in the emergency department of a university hospital between November 1, 2023, and May 31, 2025.
Who may be able to join
- Age 18 years or older.
- Underwent intravenous sedation with ketamine or propofol in the emergency department for fracture or dislocation reduction.
- Underwent intravenous sedation with ketamine or propofol in the emergency department for chest tube placement.
- Underwent intravenous sedation with ketamine or propofol in the emergency department for imaging.
- Underwent intravenous sedation with ketamine or propofol in the emergency department for gastrointestinal endoscopy.
- Had no ocular disease or intracranial pathology.
- Provided informed consent to participate in the study.
Who cannot join
- Did not provide informed consent.
- Could not undergo optic nerve sheath diameter (ONSD) measurement because of inability to cooperate with ocular ultrasonography.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Alanya Alaaddin Keykubat University Hospital
Antalya, Antalya, 07425
About this study
Official title: Comparison of the Effects of Sedation Agents on Optic Nerve Sheath Diameter in the Emergency Department
This prospective observational study aims to evaluate the acute effects of ketamine and propofol sedation on optic nerve sheath diameter (ONSD) in adult patients undergoing procedural sedation in the emergency department. ONSD is a noninvasive ultrasonographic measurement that may reflect changes in intracranial pressure. Adult patients who receive intravenous ketamine or propofol for procedural sedation will be included. The sedative agent will be selected by the treating physician according to routine clinical practice, and patients will not be randomly assigned to treatment groups. ONSD will be measured using ocular ultrasonography before and after sedation. The primary purpose of the study is to compare changes in ONSD following ketamine and propofol administration and to evaluate whether these commonly used sedative agents have different effects on ONSD.
- Conditions
- Procedural Sedation
- Keywords
- Ketamine, Propofol, Intracranial pressure, Optic nerve sheath diameter, Ultrasonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ketamine Group | Adult patients who received intravenous ketamine for procedural sedation in the emergency department as part of routine clinical care. The sedative agent was selected by the treating physician, not assigned by the study protocol. Ketamine was administered at a dose of 0.5 mg/kg as a slow intravenous bolus over approximately 60 seconds. Optic nerve sheath diameter (ONSD) was assessed before and after sedation. | |
| Propofol Group | Adult patients who received intravenous propofol for procedural sedation in the emergency department as part of routine clinical care. The sedative agent was selected by the treating physician, not assigned by the study protocol.Propofol was administered at a dose of 1 mg/kg as a slow intravenous bolus over approximately 60 seconds. Optic nerve sheath diameter (ONSD) was assessed before and after sedation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Optic Nerve Sheath Diameter (ONSD) From Baseline to 5 Minutes After Sedation
The primary outcome is the change in optic nerve sheath diameter (ONSD) from baseline to 5 minutes after intravenous sedation with ketamine or propofol. ONSD is measured using ocular ultrasonography in both eyes with the patient in the supine position. Measurements are obtained 3 mm posterior to the globe using a 7.5-MHz linear probe, with minimal pressure applied to the closed eyelid. Changes in ONSD are evaluated within each group and compared between the ketamine and propofol groups.
Measured: Baseline (before sedation) and 5 minutes after sedation
Secondary outcomes (7)
Change in Blood Pressure Before and After Sedation
Changes in systolic and diastolic blood pressure (mmHg) from baseline to 5 minutes after intravenous ketamine or propofol administration are assessed and compared between the two groups.
Measured: Baseline (before sedation) and 5 minutes after sedation
Change in Heart Rate Before and After Sedation
Changes in heart rate (beats/min) from baseline to 5 minutes after intravenous ketamine or propofol administration are assessed and compared between the two groups.
Measured: Baseline (before sedation) and 5 minutes after sedation
Change in Peripheral Oxygen Saturation Before and After Sedation
Changes in peripheral oxygen saturation (SpO₂, %) from baseline to 5 minutes after intravenous ketamine or propofol administration are assessed and compared between the two groups.
Measured: Baseline (before sedation) and 5 minutes after sedation
Change in Body Temperature Before and After Sedation
Changes in body temperature (°C) from baseline to 5 minutes after intravenous ketamine or propofol administration are assessed and compared between the two groups.
Measured: Baseline (before sedation) and 5 minutes after sedation
Change in Glasgow Coma Scale (GCS) Score From Pre-Sedation to Post-Sedation
Glasgow Coma Scale (GCS) scores recorded before and 5 minutes after intravenous sedation with ketamine or propofol are assessed and compared within each group and between the two groups. The Glasgow Coma Scale ranges from 3 to 15, with higher scores indicating a better level of consciousness and lower scores indicating greater impairment of consciousness..
Measured: Before sedation and 5 minutes after sedative agent administration
Number of Participants Requiring an Additional Dose or an Alternative Sedative Agent
The number of participants requiring an additional dose of the initially administered sedative agent or the use of an alternative sedative agent during the sedation procedure are assessed and compared between the ketamine and propofol groups.
Measured: From initial sedative administration through the 5-minute post-sedation assessment
Number of Participants with Clinically Significant Hemodynamic Deterioration Requiring Intervention
The occurrence of clinically significant hemodynamic deterioration requiring clinical intervention are assessed. Interventions of interest included intravenous fluid administration, vasopressor use, airway manoeuvres, and escalation of oxygen therapy.
Measured: From sedative administration through the 5-minute post-sedation assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start1 Nov 2023
- Primary completion31 May 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Procedural SedationStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 73 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Alanya Alaaddin Keykubat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ismail Erkan Aydin, Alanya Alaaddin Keykubat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07882524
- Sponsor's protocol ID
- ID: 04-19 (June 1, 2022 )
- Status last verified
- Oct 2026
- First submitted
- 10 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be made available upon reasonable request to the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Sedation Agents on Optic Nerve Sheath Diameter in the Emergency Department
- ClinicalTrials.gov ID
- NCT07882524
- Acronym / sponsor ID
- ID: 04-19 (June 1, 2022 )
- Conditions
- Procedural Sedation
- Keywords
- Ketamine, Propofol, Intracranial pressure, Optic nerve sheath diameter, Ultrasonography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Alanya Alaaddin Keykubat UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 20 Oct 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 prospective observational study aims to evaluate the acute effects of ketamine and propofol sedation on optic nerve sheath diameter (ONSD) in adult patients undergoing procedural sedation in the emergency department. ONSD is a noninvasive ultrasonographic measurement that may reflect changes in intracranial pressure. Adult patients who receive intravenous ketamine or propofol for procedural sedation will be included. The sedative agent will be selected by the treating physician according to routine clinical practice, and patients will not be randomly assigned to treatment groups. ONSD will be measured using ocular ultrasonography before and after sedation. The primary purpose of the study is to compare changes in ONSD following ketamine and propofol administration and to evaluate whether these commonly used sedative agents have different effects on ONSD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine Group | – | –Adult patients who received intravenous ketamine for procedural sedation in the emergency department as part of routine clinical care. The sedative agent was selected by the treating physician, not assigned by the study protocol. Ketamine was administered at a dose of 0.5 mg/kg as a slow intravenous bolus over approximately 60 seconds. Optic nerve sheath diameter (ONSD) was assessed before and after sedation. |
| Propofol Group | – | –Adult patients who received intravenous propofol for procedural sedation in the emergency department as part of routine clinical care. The sedative agent was selected by the treating physician, not assigned by the study protocol.Propofol was administered at a dose of 1 mg/kg as a slow intravenous bolus over approximately 60 seconds. Optic nerve sheath diameter (ONSD) was assessed before and after sedation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This prospective, observational, single-center cohort study was conducted in the emergency department of a university hospital between November 1, 2023, and May 31, 2025.
Key inclusion criteria (7 listed)
- Age 18 years or older.
- Underwent intravenous sedation with ketamine or propofol in the emergency department for fracture or dislocation reduction.
- Underwent intravenous sedation with ketamine or propofol in the emergency department for chest tube placement.
- Underwent intravenous sedation with ketamine or propofol in the emergency department for imaging.
- Underwent intravenous sedation with ketamine or propofol in the emergency department for gastrointestinal endoscopy.
Key exclusion criteria (2 listed)
- Did not provide informed consent.
- Could not undergo optic nerve sheath diameter (ONSD) measurement because of inability to cooperate with ocular ultrasonography.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Optic Nerve Sheath Diameter (ONSD) From Baseline to 5 Minutes After Sedation
Time frame: Baseline (before sedation) and 5 minutes after sedation
The primary outcome is the change in optic nerve sheath diameter (ONSD) from baseline to 5 minutes after intravenous sedation with ketamine or propofol. ONSD is measured using ocular ultrasonography in both eyes with the patient in the supine position. Measurements are obtained 3 mm posterior to the globe using a 7.5-MHz linear probe, with minimal pressure applied to the closed eyelid. Changes in ONSD are evaluated within each group and compared between the ketamine and propofol groups.
7 secondary outcomes
Change in Blood Pressure Before and After Sedation
Time frame: Baseline (before sedation) and 5 minutes after sedation
Change in Heart Rate Before and After Sedation
Time frame: Baseline (before sedation) and 5 minutes after sedation
Change in Peripheral Oxygen Saturation Before and After Sedation
Time frame: Baseline (before sedation) and 5 minutes after sedation
Change in Body Temperature Before and After Sedation
Time frame: Baseline (before sedation) and 5 minutes after sedation
Change in Glasgow Coma Scale (GCS) Score From Pre-Sedation to Post-Sedation
Time frame: Before sedation and 5 minutes after sedative agent administration
Number of Participants Requiring an Additional Dose or an Alternative Sedative Agent
Time frame: From initial sedative administration through the 5-minute post-sedation assessment
Number of Participants with Clinically Significant Hemodynamic Deterioration Requiring Intervention
Time frame: From sedative administration through the 5-minute post-sedation assessment
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 20 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be made available upon reasonable request to the corresponding author.
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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 Procedural Sedation, run by Alanya Alaaddin Keykubat University 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 7 inclusion and 2 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 20 Oct 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) From Baseline to 5 Minutes After Sedation (time frame: Baseline (before sedation) and 5 minutes after sedation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Oct 2026.