Cerebral HypoperfusionNIRSNCT06928870
The Effect of Controlled Hypotension
A study testing MAP 55-65 mmHg and MAP 66-75 mmHg in people with Cerebral Hypoperfusion and Hypotension, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Controlled hypotension is currently used in spinal surgery to reduce bleeding at the surgical site, improve the surgeon's visibility, and decrease intraoperative blood loss. Although controlled hypotension is considered a beneficial method from a surgical perspective, it is important to be cautious about its side… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cerebral Hypoperfusion, Hypotension
- What is being tested?
- MAP 55-65 mmHg and MAP 66-75 mmHg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Apr 2025to 30 Jun 2025
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-65 years
- ASA I-III risk group
- BMI between 18-40
- Baseline blood pressure below 140/90 mmHg
- Scheduled to undergo spinal surgery (2-4 level instrumentation)
Who cannot join
- Below 18 or above 65 years old
- Advanced comorbidities
- ASA IV or higher
- Baseline blood pressure above 140/90 mmHg
- History of bleeding diathesis
- Use of anticoagulant medications
- BMI below 18 or above 40
- History of previous spinal surgery
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
Ankara Etlik City Hospital
Ankara, Varlık Mahallesi Yenimahalle, 06170
damla usalan, +903127970000
About this study
Official title: The Effect of Controlled Hypotension on Cerebral Oxygen Saturation in Spinal Surgery
Controlled hypotension is currently used in spinal surgery to reduce bleeding at the surgical site, improve the surgeon's visibility, and decrease intraoperative blood loss. Although controlled hypotension is considered a beneficial method from a surgical perspective, it is important to be cautious about its side effects. One such side effect is cerebral perfusion insufficiency, which can be managed by monitoring cerebral circulation through regional cerebral oxygen saturation (rSO2).
The aim of this study is to compare the effects of controlled hypotension at specific MAP ranges on cerebral oxygen saturation.
Read the detailed description
Controlled hypotension is currently used in spinal surgery to reduce bleeding at the surgical site, improve the surgeon's visibility, and decrease intraoperative blood loss. Although controlled hypotension is considered a beneficial method from a surgical perspective, it is important to be cautious about its side effects. One such side effect is cerebral perfusion insufficiency, which can be managed by monitoring cerebral circulation through regional cerebral oxygen saturation (rSO2).
In the literature, various definitions of controlled hypotension exist. It is commonly defined as maintaining the Mean Arterial Pressure (MAP) between 50-65 mmHg, Systolic Arterial Pressure (SAP) between 80-90 mmHg, or reducing MAP by 30% compared to baseline values. In our study, we plan to maintain the MAP within the range of 55-75 mmHg and compare the effects of two different MAP levels on perioperative cerebral oxygen saturation, anesthetic and surgical parameters, and postoperative cognitive functions.
The aim of this study is to compare the effects of controlled hypotension at specific MAP ranges on cerebral oxygen saturation.
- Conditions
- Cerebral Hypoperfusion, Hypotension
- Being tested
- MAP 55-65 mmHg, MAP 66-75 mmHg
- Keywords
- cerebral oxygen saturation, NIRS, controlled hypotension
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAP 55-65 mmHgOther
MAP will be maintained between 55-65 mmHg during anesthesia.
MAP 66-75 mmHgOther
MAP will be maintained between 66-75 mmHg during anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Group MAP 55-65 mmHg | Other | Group - MAP 55-65 mmHg: MAP will be maintained between 55-65 mmHg during anesthesia. Receives: Other: MAP 55-65 mmHg |
| Group MAP 66-75 mmHg | Other | Group - MAP 66-75 mmHg: MAP will be maintained between 66-75 mmHg during anesthesia. Receives: Other: MAP 66-75 mmHg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Near infrared spectroscopy (NIRS)
cerebral oxygen saturation
Measured: 5 minutes before induction of anesthesia
Near infrared spectroscopy (NIRS)
cerebral oxygen saturation
Measured: 5 minutes after intubation
Near infrared spectroscopy (NIRS)
cerebral oxygen saturation
Measured: 5 minutes after positioning prone
Near infrared spectroscopy (NIRS)
cerebral oxygen saturation
Measured: 1 minutes after first surgical incision is made
Near infrared spectroscopy (NIRS)
cerebral oxygen saturation
Measured: the time after one minutes target MAP value
Near infrared spectroscopy (NIRS)
cerebral oxygen saturation
Measured: the time after ten minutes target MAP value
Near infrared spectroscopy (NIRS)
cerebral oxygen saturation
Measured: the time after 20 minutes target MAP value
Near infrared spectroscopy (NIRS)
cerebral oxygen saturation
Measured: 5 minutes after extubation
Near infrared spectroscopy (NIRS)
cerebral oxygen saturation
Measured: postextubation after 15 minutes
Secondary outcomes (2)
mini mental test
It is used to evaluate cognitive function.
Measured: 15 minutes before induction of anesthesia
mini mental test
It is used to evaluate cognitive function.
Measured: 30 minutes after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start30 Apr 2025 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cerebral HypoperfusionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Damla Usalan, Ankara Etlik City Hospital
- Investigators
- damla usalan, Principal investigator, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06928870
- Sponsor's protocol ID
- AEŞH-EK1-2024-0003
- Acronym
- NIRS
- Status last verified
- Apr 2025
- First submitted
- 7 Feb 2025
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dutton RP. Controlled hypotension for spinal surgery. Eur Spine J. 2004 Oct;13 Suppl 1(Suppl 1):S66-71. doi: 10.1007/s00586-004-0756-7. Epub 2004 Jun 9.
PubMed 15197633Ooms M, Schooss R, Winnand P, Heitzer M, Holzle F, Bickenbach J, Rieg A, Modabber A. Influence of perioperative blood pressure regulation on postoperative delirium in patients undergoing head and neck free flap reconstruction. Eur J Med Res. 2023 Sep 22;28(1):365. doi: 10.1186/s40001-023-01367-1.
PubMed 37736691
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Controlled Hypotension on Cerebral Oxygen Saturation in Spinal Surgery
- ClinicalTrials.gov ID
- NCT06928870
- Acronym / sponsor ID
- NIRS / AEŞH-EK1-2024-0003
- Conditions
- Cerebral Hypoperfusion, Hypotension
- Keywords
- cerebral oxygen saturation, NIRS, controlled hypotension
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 30 Apr 2025 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 15 Apr 2025 (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.
Controlled hypotension is currently used in spinal surgery to reduce bleeding at the surgical site, improve the surgeon's visibility, and decrease intraoperative blood loss. Although controlled hypotension is considered a beneficial method from a surgical perspective, it is important to be cautious about its side effects. One such side effect is cerebral perfusion insufficiency, which can be managed by monitoring cerebral circulation through regional cerebral oxygen saturation (rSO2).
The aim of this study is to compare the effects of controlled hypotension at specific MAP ranges on cerebral oxygen saturation.
Detailed description
Controlled hypotension is currently used in spinal surgery to reduce bleeding at the surgical site, improve the surgeon's visibility, and decrease intraoperative blood loss. Although controlled hypotension is considered a beneficial method from a surgical perspective, it is important to be cautious about its side effects. One such side effect is cerebral perfusion insufficiency, which can be managed by monitoring cerebral circulation through regional cerebral oxygen saturation (rSO2).
In the literature, various definitions of controlled hypotension exist. It is commonly defined as maintaining the Mean Arterial Pressure (MAP) between 50-65 mmHg, Systolic Arterial Pressure (SAP) between 80-90 mmHg, or reducing MAP by 30% compared to baseline values. In our study, we plan to maintain the MAP within the range of 55-75 mmHg and compare the effects of two different MAP levels on perioperative cerebral oxygen saturation, anesthetic and surgical parameters, and postoperative cognitive functions.
The aim of this study is to compare the effects of controlled hypotension at specific MAP ranges on cerebral oxygen saturation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group MAP 55-65 mmHg | Other | Other: MAP 55-65 mmHgGroup - MAP 55-65 mmHg: MAP will be maintained between 55-65 mmHg during anesthesia. |
| Group MAP 66-75 mmHg | Other | Other: MAP 66-75 mmHgGroup - MAP 66-75 mmHg: MAP will be maintained between 66-75 mmHg during anesthesia. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18-65 years
- ASA I-III risk group
- BMI between 18-40
- Baseline blood pressure below 140/90 mmHg
- Scheduled to undergo spinal surgery (2-4 level instrumentation)
Key exclusion criteria (8 listed)
- Below 18 or above 65 years old
- Advanced comorbidities
- ASA IV or higher
- Baseline blood pressure above 140/90 mmHg
- History of bleeding diathesis
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 |
|---|---|---|
| MAP 55-65 mmHgMAP will be maintained between 55-65 mmHg during anesthesia. | Other | Group MAP 55-65 mmHg |
| MAP 66-75 mmHgMAP will be maintained between 66-75 mmHg during anesthesia. | Other | Group MAP 66-75 mmHg |
Primary outcome
Near infrared spectroscopy (NIRS)
Time frame: 5 minutes before induction of anesthesia
cerebral oxygen saturation
Near infrared spectroscopy (NIRS)
Time frame: 5 minutes after intubation
cerebral oxygen saturation
Near infrared spectroscopy (NIRS)
Time frame: 5 minutes after positioning prone
cerebral oxygen saturation
Near infrared spectroscopy (NIRS)
Time frame: 1 minutes after first surgical incision is made
cerebral oxygen saturation
Near infrared spectroscopy (NIRS)
Time frame: the time after one minutes target MAP value
cerebral oxygen saturation
Near infrared spectroscopy (NIRS)
Time frame: the time after ten minutes target MAP value
cerebral oxygen saturation
Near infrared spectroscopy (NIRS)
Time frame: the time after 20 minutes target MAP value
cerebral oxygen saturation
Near infrared spectroscopy (NIRS)
Time frame: 5 minutes after extubation
cerebral oxygen saturation
Near infrared spectroscopy (NIRS)
Time frame: postextubation after 15 minutes
cerebral oxygen saturation
2 secondary outcomes
mini mental test
Time frame: 15 minutes before induction of anesthesia
mini mental test
Time frame: 30 minutes after extubation
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 15 Apr 2025.
- Background: PubMed 15197633Dutton RP. Controlled hypotension for spinal surgery. Eur Spine J. 2004 Oct;13 Suppl 1(Suppl 1):S66-71. doi: 10.1007/s00586-004-0756-7. Epub 2004 Jun 9.
- Results publication: PubMed 37736691Ooms M, Schooss R, Winnand P, Heitzer M, Holzle F, Bickenbach J, Rieg A, Modabber A. Influence of perioperative blood pressure regulation on postoperative delirium in patients undergoing head and neck free flap reconstruction. Eur J Med Res. 2023 Sep 22;28(1):365. doi: 10.1186/s40001-023-01367-1.
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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.
damla usalan principal investigator
Ankara Etlik City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MAP 55-65 mmHg and MAP 66-75 mmHg in people with Cerebral Hypoperfusion and Hypotension, run by Ankara Etlik City Hospital 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 15 Apr 2025. 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?
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 damla usalan (+905059181063, dusalan78@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Near infrared spectroscopy (NIRS) (time frame: 5 minutes before induction of anesthesia). The study lists 9 primary outcomes in all. 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 NCT06928870, which also lists 2 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 15 Apr 2025.