Spinal Anesthesia-Induced HypotensionPhase 4NCT07858149
Effects of Ondansetron Timing During Spinal Anesthesia for Urologic Surgery
A Phase 4 study testing Ondansetron 8 mg and 0.9 % sodium chloride in people with Spinal Anesthesia-Induced Hypotension and Cerebral Oxygenation, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
This study will evaluate whether the timing of intravenous ondansetron administration affects cerebral oxygenation and hemodynamic stability in older adults undergoing endoscopic urologic surgery under spinal anesthesia. Read more about this study
- Who is it for?
- Ages 65 years and older, men only
- Conditions the study is for
- Spinal Anesthesia-Induced Hypotension, Cerebral Oxygenation
- What is being tested?
- Ondansetron 8 mg and 0.9 % sodium chloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Sep 2026to 22 Jan 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 65 years and older
- Men only
- No healthy volunteers
- Older adult
Who may be able to join
- Male sex.
- Age 65 years or older.
- ASA physical status I-III.
- Scheduled for elective transurethral resection of the prostate (TUR-P) or transurethral resection of bladder tumor (TUR-BT) under spinal anesthesia.
- Ability to provide written informed consent.
Who cannot join
- Known hypersensitivity or contraindication to ondansetron.
- Corrected QT interval (QTc) >480 ms.
- Significant cardiac conduction abnormality.
- Concomitant use of medications known to prolong the QT interval.
- Severe ischemic heart disease.
- Severe chronic obstructive pulmonary disease.
- Skin lesion, wound, or other condition preventing placement of frontal NIRS sensors.
- Contraindication to spinal anesthesia.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine
Fatih, Istanbul, 34360
Ezi Budak Özyalçın, Anesthesiology Specialist, 05056043177, budakezgi@gmail.com
Fatiş Altındaş, Professor of Anesthesiology, +905537785278, fatisaltintas@hotmail.com
About this study
Official title: Clinical Effects of Ondansetron Administration in Patients Undergoing Urologic Surgery Under Spinal Anesthesia
This study will evaluate whether the timing of intravenous ondansetron administration affects cerebral oxygenation and hemodynamic stability in older adults undergoing endoscopic urologic surgery under spinal anesthesia.
Participants aged 65 years or older will be randomly assigned to one of three groups: ondansetron administered before spinal anesthesia, ondansetron administered after spinal anesthesia, or placebo. Ondansetron will be administered intravenously at a dose of 8 mg.
Read more
Cerebral oxygenation will be assessed using bilateral frontal near-infrared spectroscopy (NIRS). Regional cerebral oxygen saturation (rSO₂) will be recorded before spinal anesthesia and at 5-minute intervals during the first 60 minutes after spinal anesthesia.
The study will also evaluate blood pressure, heart rate, vasopressor requirements, bradycardia, postoperative nausea and vomiting, post-spinal headache, and postoperative delirium.
The aim is to determine whether the timing of ondansetron administration influences cerebral oxygenation and hemodynamic stability after spinal anesthesia.
Read the detailed description
This is a single-center, prospective, randomized, double-blind, placebo-controlled, three-arm parallel-group clinical trial in adults aged 65 years or older undergoing endoscopic urologic surgery under spinal anesthesia.
Spinal anesthesia may cause hypotension and bradycardia because of sympathetic blockade, reduced venous return, and activation of reflex mechanisms including the Bezold-Jarisch reflex. Ondansetron is a 5-hydroxytryptamine type 3 (5-HT₃) receptor antagonist that may attenuate these hemodynamic changes.
Participants will be randomized to receive one of three study strategies: intravenous ondansetron 8 mg before spinal anesthesia, intravenous ondansetron 8 mg after spinal anesthesia, or placebo. Study solutions will be prepared in a blinded manner so that participants and relevant clinical and outcome-assessment personnel remain unaware of treatment allocation.
Cerebral oxygenation will be assessed using bilateral frontal near-infrared spectroscopy. Left and right regional cerebral oxygen saturation (rSO₂) values will be recorded before spinal anesthesia and at 5-minute intervals during the first 60 minutes following spinal anesthesia.
Hemodynamic variables, including blood pressure and heart rate, will be monitored throughout the study period. The need for vasopressor treatment, total vasopressor dose, bradycardia, and atropine use will also be recorded. Postoperative outcomes will include nausea and vomiting, rescue antiemetic use, post-spinal headache, and postoperative delirium assessed using the 4AT.
The study is designed to compare the effects of different timings of ondansetron administration on cerebral oxygenation and hemodynamic stability during the early period after spinal anesthesia.
- Being tested
- Ondansetron 8 mg, 0.9 % sodium chloride
- Keywords
- Ondansetron, Spinal anesthesia, Regional cerebral oxygen saturation, Near-infrared spectroscopy, Urologic surgery, Older adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ondansetron 8 mgDrug
Ondansetron 8 mg will be administered intravenously according to the assigned study arm. In the early ondansetron arm, the drug will be administered approximately 10 minutes before completion of the intrathecal injection. In the late ondansetron arm, the drug will be administered approximately 5 minutes after completion of the intrathecal injection.
0.9 % sodium chlorideDrug
Placebo will be administered intravenously in the same volume and appearance as the active study drug according to the blinded study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Early Ondansetron | Experimental | Participants will receive ondansetron 8 mg intravenously approximately 10 minutes before completion of the intrathecal injection. Receives: Drug: Ondansetron 8 mg; Drug: 0.9 % sodium chloride |
| Late Ondansetron | Active comparator | Participants will receive ondansetron 8 mg intravenously approximately 5 minutes after completion of the intrathecal injection. Receives: Drug: Ondansetron 8 mg; Drug: 0.9 % sodium chloride |
| Placebo | Placebo comparator | Participants will receive placebo according to the blinded study protocol at the corresponding study time points. Receives: Drug: 0.9 % sodium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bilateral Frontal Regional Cerebral Oxygen Saturation (rSO₂)
Regional cerebral oxygen saturation (rSO₂, %) will be measured bilaterally over the frontal cortex using near-infrared spectroscopy. Left and right rSO₂ values will be recorded at each prespecified assessment time point.
Measured: Before spinal anesthesia (baseline) and at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, and 60 minutes after spinal anesthesia
Secondary outcomes (13)
Incidence of Hypotension
Hypotension will be defined as a mean arterial pressure (MAP) below 65 mmHg and/or a reduction in systolic blood pressure of at least 30% from baseline.
Measured: During the first 60 minutes after spinal anesthesia
Time to First Hypotensive Episode
Time from completion of spinal anesthesia to the first episode meeting the predefined criteria for hypotension.
Measured: During the first 60 minutes after spinal anesthesia
Requirement for Ephedrine
Proportion of participants requiring intravenous ephedrine for treatment of hypotension.
Measured: During the first 60 minutes after spinal anesthesia
Total Ephedrine Dose
Total cumulative dose of intravenous ephedrine administered for treatment of hypotension, measured in milligrams.
Measured: During the first 60 minutes after spinal anesthesia
Incidence of Bradycardia
Bradycardia will be defined as a heart rate below 45 beats per minute.
Measured: During the first 60 minutes after spinal anesthesia
Requirement for Atropine
Proportion of participants requiring intravenous atropine for treatment of bradycardia.
Measured: During the first 60 minutes after spinal anesthesia
Minimum Regional Cerebral Oxygen Saturation
The lowest recorded frontal regional cerebral oxygen saturation (rSO₂, %) value during the observation period will be determined from the prespecified bilateral NIRS measurements.
Measured: From baseline to 60 minutes after spinal anesthesia
Maximum Relative Decrease in Regional Cerebral Oxygen Saturation
Maximum percentage decrease in frontal regional cerebral oxygen saturation (rSO₂) from the corresponding pre-spinal baseline value.
Measured: From baseline to 60 minutes after spinal anesthesia
Incidence of Cerebral Desaturation
Cerebral desaturation will be defined as a decrease in frontal regional cerebral oxygen saturation (rSO₂) of at least 20% from the corresponding pre-spinal baseline value at any prespecified measurement time point.
Measured: From baseline to 60 minutes after spinal anesthesia
Postoperative Nausea Severity
Postoperative nausea severity will be assessed using an 11-point Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no nausea and 10 indicates the worst possible nausea. Higher scores indicate worse nausea.
Measured: From the end of surgery through the first postoperative day
Requirement for Rescue Antiemetic Treatment
Proportion of participants requiring rescue antiemetic medication for postoperative nausea or vomiting.
Measured: From the end of surgery through the first postoperative day
Post-Spinal Headache Severity
Post-spinal headache severity will be assessed using an 11-point Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no headache and 10 indicates the worst possible headache. Higher scores indicate worse headache.
Measured: During the first postoperative day
Incidence of Postoperative Delirium
Postoperative delirium will be assessed using the 4 'A's Test (4AT), which ranges from 0 to 12. Higher scores indicate a greater likelihood of delirium. A score of 4 or greater will be considered positive for possible delirium. The 4 'A's Test (4AT) assesses alertness, abbreviated mental test-4, attention, and acute change or fluctuating course.
Measured: In the post-anesthesia care unit, approximately 12 hours after surgery, and on the first postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start30 Sep 2026 (estimated)
- Primary completion2 Jan 2027 (estimated)
- Study completion22 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Spinal Anesthesia-Induced HypotensionStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned to one of three parallel groups: ondansetron administered before spinal anesthesia, ondansetron administered after spinal anesthesia, or placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ezgi Budak Ozyalcın, Istanbul University
- Investigators
- Ezgi Budak Ozyalcin, Anesthesiology Specialist, Principal investigator, Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine, Department of Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07858149
- Sponsor's protocol ID
- E-24687260-604.01-1731844
- Status last verified
- Sep 2026
- First submitted
- 30 Sep 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared because no formal data-sharing plan has been established for this study.
Publications
Nishikawa K, Hagiwara R, Nakamura K, Ishizeki J, Kubo K, Saito S, Goto F. The effects of the extent of spinal block on the BIS score and regional cerebral oxygen saturation in elderly patients: A prospective, randomized, and double-blinded study. J Clin Monit Comput. 2007 Apr;21(2):109-14. doi: 10.1007/s10877-006-9063-7. Epub 2007 Jan 10.
PubMed 17216322Tatikonda CM, Rajappa GC, Rath P, Abbas M, Madhapura VS, Gopal NV. Effect of Intravenous Ondansetron on Spinal Anesthesia-Induced Hypotension and Bradycardia: A Randomized Controlled Double-Blinded Study. Anesth Essays Res. 2019 Apr-Jun;13(2):340-346. doi: 10.4103/aer.AER_22_19.
PubMed 31198257Mendonca FT, Crepaldi Junior LC, Gersanti RC, de Araujo KC. Effect of ondansetron on spinal anesthesia-induced hypotension in non-obstetric surgeries: a randomised, double-blind and placebo-controlled trial. Braz J Anesthesiol. 2021 May-Jun;71(3):233-240. doi: 10.1016/j.bjane.2020.12.028. Epub 2021 Mar 22.
PubMed 33766681Kusku A, Demir G, Cukurova Z, Eren G, Hergunsel O. Monitorization of the effects of spinal anaesthesia on cerebral oxygen saturation in elder patients using near-infrared spectroscopy. Braz J Anesthesiol. 2014 Jul-Aug;64(4):241-6. doi: 10.1016/j.bjane.2013.06.012. Epub 2013 Oct 18.
PubMed 24998107
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effects of Ondansetron Administration in Patients Undergoing Urologic Surgery Under Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT07858149
- Acronym / sponsor ID
- E-24687260-604.01-1731844
- Keywords
- Ondansetron, Spinal anesthesia, Regional cerebral oxygen saturation, Near-infrared spectroscopy, Urologic surgery, Older adults
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 2 Jan 2027 (estimated)
- Study completion
- 22 Jan 2027 (estimated)
- First posted
- 5 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 study will evaluate whether the timing of intravenous ondansetron administration affects cerebral oxygenation and hemodynamic stability in older adults undergoing endoscopic urologic surgery under spinal anesthesia.
Participants aged 65 years or older will be randomly assigned to one of three groups: ondansetron administered before spinal anesthesia, ondansetron administered after spinal anesthesia, or placebo. Ondansetron will be administered intravenously at a dose of 8 mg.
Cerebral oxygenation will be assessed using bilateral frontal near-infrared spectroscopy (NIRS). Regional cerebral oxygen saturation (rSO₂) will be recorded before spinal anesthesia and at 5-minute intervals during the first 60 minutes after spinal anesthesia.
The study will also evaluate blood pressure, heart rate, vasopressor requirements, bradycardia, postoperative nausea and vomiting, post-spinal headache, and postoperative delirium.
The aim is to determine whether the timing of ondansetron administration influences cerebral oxygenation and hemodynamic stability after spinal anesthesia.
Detailed description
This is a single-center, prospective, randomized, double-blind, placebo-controlled, three-arm parallel-group clinical trial in adults aged 65 years or older undergoing endoscopic urologic surgery under spinal anesthesia.
Spinal anesthesia may cause hypotension and bradycardia because of sympathetic blockade, reduced venous return, and activation of reflex mechanisms including the Bezold-Jarisch reflex. Ondansetron is a 5-hydroxytryptamine type 3 (5-HT₃) receptor antagonist that may attenuate these hemodynamic changes.
Participants will be randomized to receive one of three study strategies: intravenous ondansetron 8 mg before spinal anesthesia, intravenous ondansetron 8 mg after spinal anesthesia, or placebo. Study solutions will be prepared in a blinded manner so that participants and relevant clinical and outcome-assessment personnel remain unaware of treatment allocation.
Cerebral oxygenation will be assessed using bilateral frontal near-infrared spectroscopy. Left and right regional cerebral oxygen saturation (rSO₂) values will be recorded before spinal anesthesia and at 5-minute intervals during the first 60 minutes following spinal anesthesia.
Hemodynamic variables, including blood pressure and heart rate, will be monitored throughout the study period. The need for vasopressor treatment, total vasopressor dose, bradycardia, and atropine use will also be recorded. Postoperative outcomes will include nausea and vomiting, rescue antiemetic use, post-spinal headache, and postoperative delirium assessed using the 4AT.
The study is designed to compare the effects of different timings of ondansetron administration on cerebral oxygenation and hemodynamic stability during the early period after spinal anesthesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be assigned to one of three parallel groups: ondansetron administered before spinal anesthesia, ondansetron administered after spinal anesthesia, or placebo.
| Arm | Type | Receives |
|---|---|---|
| Early Ondansetron | Experimental | Drug: Ondansetron 8 mg, Drug: 0.9 % sodium chlorideParticipants will receive ondansetron 8 mg intravenously approximately 10 minutes before completion of the intrathecal injection. |
| Late Ondansetron | Active comparator | Drug: Ondansetron 8 mg, Drug: 0.9 % sodium chlorideParticipants will receive ondansetron 8 mg intravenously approximately 5 minutes after completion of the intrathecal injection. |
| Placebo | Placebo comparator | Drug: 0.9 % sodium chlorideParticipants will receive placebo according to the blinded study protocol at the corresponding study time points. |
Who may qualify
- Ages
- 65 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Male sex.
- Age 65 years or older.
- ASA physical status I-III.
- Scheduled for elective transurethral resection of the prostate (TUR-P) or transurethral resection of bladder tumor (TUR-BT) under spinal anesthesia.
- Ability to provide written informed consent.
Key exclusion criteria (8 listed)
- Known hypersensitivity or contraindication to ondansetron.
- Corrected QT interval (QTc) >480 ms.
- Significant cardiac conduction abnormality.
- Concomitant use of medications known to prolong the QT interval.
- Severe ischemic heart disease.
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 |
|---|---|---|
| Ondansetron 8 mgOndansetron 8 mg will be administered intravenously according to the assigned study arm. In the early ondansetron arm, the drug will be administered approximately 10 minutes before completion of the intrathecal injection. In the late ondansetron arm, the drug will be administered approximately 5 minutes after completion of the intrathecal injection. | Drug | Early Ondansetron, Late Ondansetron |
| 0.9 % sodium chloridePlacebo will be administered intravenously in the same volume and appearance as the active study drug according to the blinded study protocol. | Drug | Early Ondansetron, Late Ondansetron, Placebo |
Primary outcome
Bilateral Frontal Regional Cerebral Oxygen Saturation (rSO₂)
Time frame: Before spinal anesthesia (baseline) and at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, and 60 minutes after spinal anesthesia
Regional cerebral oxygen saturation (rSO₂, %) will be measured bilaterally over the frontal cortex using near-infrared spectroscopy. Left and right rSO₂ values will be recorded at each prespecified assessment time point.
13 secondary outcomes
Incidence of Hypotension
Time frame: During the first 60 minutes after spinal anesthesia
Time to First Hypotensive Episode
Time frame: During the first 60 minutes after spinal anesthesia
Requirement for Ephedrine
Time frame: During the first 60 minutes after spinal anesthesia
Total Ephedrine Dose
Time frame: During the first 60 minutes after spinal anesthesia
Incidence of Bradycardia
Time frame: During the first 60 minutes after spinal anesthesia
Requirement for Atropine
Time frame: During the first 60 minutes after spinal anesthesia
Minimum Regional Cerebral Oxygen Saturation
Time frame: From baseline to 60 minutes after spinal anesthesia
Maximum Relative Decrease in Regional Cerebral Oxygen Saturation
Time frame: From baseline to 60 minutes after spinal anesthesia
Incidence of Cerebral Desaturation
Time frame: From baseline to 60 minutes after spinal anesthesia
Postoperative Nausea Severity
Time frame: From the end of surgery through the first postoperative day
Requirement for Rescue Antiemetic Treatment
Time frame: From the end of surgery through the first postoperative day
Post-Spinal Headache Severity
Time frame: During the first postoperative day
Incidence of Postoperative Delirium
Time frame: In the post-anesthesia care unit, approximately 12 hours after surgery, and on the first postoperative day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Background: PubMed 17216322Nishikawa K, Hagiwara R, Nakamura K, Ishizeki J, Kubo K, Saito S, Goto F. The effects of the extent of spinal block on the BIS score and regional cerebral oxygen saturation in elderly patients: A prospective, randomized, and double-blinded study. J Clin Monit Comput. 2007 Apr;21(2):109-14. doi: 10.1007/s10877-006-9063-7. Epub 2007 Jan 10.
- Background: PubMed 31198257Tatikonda CM, Rajappa GC, Rath P, Abbas M, Madhapura VS, Gopal NV. Effect of Intravenous Ondansetron on Spinal Anesthesia-Induced Hypotension and Bradycardia: A Randomized Controlled Double-Blinded Study. Anesth Essays Res. 2019 Apr-Jun;13(2):340-346. doi: 10.4103/aer.AER_22_19.
- Background: PubMed 33766681Mendonca FT, Crepaldi Junior LC, Gersanti RC, de Araujo KC. Effect of ondansetron on spinal anesthesia-induced hypotension in non-obstetric surgeries: a randomised, double-blind and placebo-controlled trial. Braz J Anesthesiol. 2021 May-Jun;71(3):233-240. doi: 10.1016/j.bjane.2020.12.028. Epub 2021 Mar 22.
- Background: PubMed 24998107Kusku A, Demir G, Cukurova Z, Eren G, Hergunsel O. Monitorization of the effects of spinal anaesthesia on cerebral oxygen saturation in elder patients using near-infrared spectroscopy. Braz J Anesthesiol. 2014 Jul-Aug;64(4):241-6. doi: 10.1016/j.bjane.2013.06.012. Epub 2013 Oct 18.
- Individual participant dataSharing planned: No. IPD will not be shared because no formal data-sharing plan has been established for this study.
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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.
Ezgi Budak Ozyalcin, Anesthesiology Specialist principal investigator
Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine, Department of Anesthesiology and Reanimation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ondansetron 8 mg and 0.9 % sodium chloride in people with Spinal Anesthesia-Induced Hypotension and Cerebral Oxygenation, run by Istanbul 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 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: opening soon, as of the sponsor's last update on 19 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ezgi Budak Ozyalcin, Anesthesiology Specialist (+905056043177, budakezgi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bilateral Frontal Regional Cerebral Oxygen Saturation (rSO₂) (time frame: Before spinal anesthesia (baseline) and at 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, and 60 minutes after spinal anesthesia). 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 NCT07858149, which also lists 4 linked publications.
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 19 Oct 2026.