Cerebral OxygenationNCT06325462
The Influence of Anesthetic Technique on Cerebral Oxygenation During Spinal Surgery
An observational study of Cerebral Oxygenation, run by Prince Sultan Military Medical City at 1 site in Saudi Arabia.
Trial summary
Postural changes during anesthesia can lead to decreased cerebral blood flow and oxygenation, especially when moving from a supine to a prone position. This is particularly relevant during spinal surgery with controlled hypotension. Read more about this study
- Who is it for?
- Ages 18 to 68 years
- Conditions the study is for
- Cerebral Oxygenation
- What is being tested?
- sensors of regional cerebral oxygen saturation (O3 regional oximeter, Masimo Corp, Irvine, CA) FDA Reg No. 3011353843
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 54 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 10 Feb 2024to 1 Dec 2024
- 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 68 years
- All sexes
- Adult, Older adult
Study population: Fifty-four patients of both sexes between 18 and 68 years
Who may be able to join
- American Society of Anesthesiologists (ASA) Physical Status I and II
- Scheduled for elective spinal surgery
- Prone position
- General anesthesia with controlled hypotension.
Who cannot join
- Hypertension
- Coronary artery disease
- Renal, hepatic, or cerebral insufficiency,
- Patients with coagulopathy or receiving drugs affecting coagulation
- Grossly anemic
- Hypovolemic patients
Show all 10Show fewer
- Chronically diseased and debilitated patients,
- Bleeding more than 200 mL
- Hemodynamic instability (decrease of 25% of baseline mean arterial pressure [MAP] for three minutes)
- Patients with significant baseline bradycardia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Different Anesthetic Techniques on Cerebral Oxygenation During Spinal Surgery in a Prone Position With Controlled Hypotension
Postural changes during anesthesia can lead to decreased cerebral blood flow and oxygenation, especially when moving from a supine to a prone position. This is particularly relevant during spinal surgery with controlled hypotension. Cerebral oximetry, monitored in the frontal cortex using an O3 sensor, is a noninvasive and continuous method to investigate the impact of anesthetic techniques on cerebral oxygenation in such scenarios.
Read the detailed description
All patients will be monitored with standard monitoring, SedLine sedation monitor, and O3 regional oximeter, Masimo Corp, Irvine, CA. Fentanyl, propofol, and cisatracurium will be administered for anesthesia induction. Anesthetic agents will be maintained with intravenous anesthetic agents in one group and sevoflurane in another group to obtain the PSI 25-50. Mean blood pressure will be maintained 20-30% below baseline. MAP, HR, SpO2, ETCO2, and SrO2 will be assessed at supine position without oxygen administration (T1), supine position with oxygen administration (T2-baseline), intubation in the supine position (T3), just after prone positioning (T4), 10 minutes after prone positioning (T5), at the end of surgery in the prone position (T6) and at the end of anesthesia in the supine position (T7).
Data will be expressed as mean and standard deviation. The mean differences will be analyzed using the Student's T test for quantitative variables in those cases in which those variables followed a normal distribution. Distribution will be evaluated by Kolmogorov-Smirnoff's Z test. Differences in proportion will be conducted with contingency analysis using Chi-square and Fisher's exact test when needed.
A P-value < 0.05 will be statistically significant. Statistical analysis will be performed using the SPSS-PC statistical software program (version 15.0; SPSS, Inc., Chicago, IL, USA).
- Conditions
- Cerebral Oxygenation
- Being tested
- sensors of regional cerebral oxygen saturation (O3 regional oximeter, Masimo Corp, Irvine, CA) FDA Reg No. 3011353843
- Keywords
- prone position, controlled hypotension, cerebral oximetry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sensors of regional cerebral oxygen saturation (O3 regional oximeter, Masimo Corp, Irvine, CA) FDA Reg No. 3011353843Device
O3 regional oximetry monitors the regional hemoglobin oxygen saturation of the blood (rSO2) in adult patients, placed on the forehead by noninvasive and continuous combining arterial and venous oxygen saturation signals from near-infrared spectroscopy (NIRS)
| Study group | Role | What they receive |
|---|---|---|
| Group S | 27 patients will receive inhalational general anesthesia using sevoflurane. Receives: Device: sensors of regional cerebral oxygen saturation (O3 regional oximeter, Masimo Corp, Irvine, CA) FDA Reg No. 3011353843 | |
| Group P | 27 patients will receive intravenous anesthesia using propofol infusion. Receives: Device: sensors of regional cerebral oxygen saturation (O3 regional oximeter, Masimo Corp, Irvine, CA) FDA Reg No. 3011353843 |
What is being measured
The primary outcome is the main question the study is designed to answer.
regional cerebral oxygen saturation
By applying the sensors of regional cerebral oxygen saturation on the forehead.
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start10 Feb 2024
- Primary completion12 Aug 2024
- Study completion1 Dec 2024
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 Cerebral OxygenationStudies 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
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prince Sultan Military Medical City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Daabiss, Prince Sultan Military Medical City
- Investigators
- Mohamed A Daabiss, M.D., Principal investigator, Prince Sultan Military Medical City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06325462
- Sponsor's protocol ID
- E2232/2023
- Status last verified
- May 2025
- First submitted
- 9 Mar 2024
- Last updated
- 16 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Chaix I, Manquat E, Liu N, Casadio MC, Ludes PO, Tantot A, Lopes JP, Touchard C, Mateo J, Mebazaa A, Gayat E, Vallee F. Impact of hypotension on cerebral perfusion during general anesthesia induction: A prospective observational study in adults. Acta Anaesthesiol Scand. 2020 May;64(5):592-601. doi: 10.1111/aas.13537. Epub 2020 Jan 19.
PubMed 31883375
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Different Anesthetic Techniques on Cerebral Oxygenation During Spinal Surgery in a Prone Position With Controlled Hypotension
- ClinicalTrials.gov ID
- NCT06325462
- Acronym / sponsor ID
- E2232/2023
- Conditions
- Cerebral Oxygenation
- Keywords
- prone position, controlled hypotension, cerebral oximetry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Prince Sultan Military Medical CityUniversity, hospital or other
- Study start
- 10 Feb 2024 (actual)
- Primary completion
- 12 Aug 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 22 Mar 2024 (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.
Postural changes during anesthesia can lead to decreased cerebral blood flow and oxygenation, especially when moving from a supine to a prone position. This is particularly relevant during spinal surgery with controlled hypotension. Cerebral oximetry, monitored in the frontal cortex using an O3 sensor, is a noninvasive and continuous method to investigate the impact of anesthetic techniques on cerebral oxygenation in such scenarios.
Detailed description
All patients will be monitored with standard monitoring, SedLine sedation monitor, and O3 regional oximeter, Masimo Corp, Irvine, CA. Fentanyl, propofol, and cisatracurium will be administered for anesthesia induction. Anesthetic agents will be maintained with intravenous anesthetic agents in one group and sevoflurane in another group to obtain the PSI 25-50. Mean blood pressure will be maintained 20-30% below baseline. MAP, HR, SpO2, ETCO2, and SrO2 will be assessed at supine position without oxygen administration (T1), supine position with oxygen administration (T2-baseline), intubation in the supine position (T3), just after prone positioning (T4), 10 minutes after prone positioning (T5), at the end of surgery in the prone position (T6) and at the end of anesthesia in the supine position (T7).
Data will be expressed as mean and standard deviation. The mean differences will be analyzed using the Student's T test for quantitative variables in those cases in which those variables followed a normal distribution. Distribution will be evaluated by Kolmogorov-Smirnoff's Z test. Differences in proportion will be conducted with contingency analysis using Chi-square and Fisher's exact test when needed.
A P-value < 0.05 will be statistically significant. Statistical analysis will be performed using the SPSS-PC statistical software program (version 15.0; SPSS, Inc., Chicago, IL, USA).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group S | – | Device: sensors of regional cerebral oxygen saturation (O3 regional oximeter, Masimo Corp, Irvine, CA) FDA Reg No. 301135384327 patients will receive inhalational general anesthesia using sevoflurane. |
| Group P | – | Device: sensors of regional cerebral oxygen saturation (O3 regional oximeter, Masimo Corp, Irvine, CA) FDA Reg No. 301135384327 patients will receive intravenous anesthesia using propofol infusion. |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Fifty-four patients of both sexes between 18 and 68 years
Key inclusion criteria (4 listed)
- American Society of Anesthesiologists (ASA) Physical Status I and II
- Scheduled for elective spinal surgery
- Prone position
- General anesthesia with controlled hypotension.
Key exclusion criteria (10 listed)
- Hypertension
- Coronary artery disease
- Renal, hepatic, or cerebral insufficiency,
- Patients with coagulopathy or receiving drugs affecting coagulation
- Grossly anemic
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 |
|---|---|---|
| sensors of regional cerebral oxygen saturation (O3 regional oximeter, Masimo Corp, Irvine, CA) FDA Reg No. 3011353843O3 regional oximetry monitors the regional hemoglobin oxygen saturation of the blood (rSO2) in adult patients, placed on the forehead by noninvasive and continuous combining arterial and venous oxygen saturation signals from near-infrared spectroscopy (NIRS) | Device | Group P, Group S |
Primary outcome
regional cerebral oxygen saturation
Time frame: up to 24 weeks
By applying the sensors of regional cerebral oxygen saturation on the forehead.
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 16 May 2025.
- Results publication: PubMed 31883375Chaix I, Manquat E, Liu N, Casadio MC, Ludes PO, Tantot A, Lopes JP, Touchard C, Mateo J, Mebazaa A, Gayat E, Vallee F. Impact of hypotension on cerebral perfusion during general anesthesia induction: A prospective observational study in adults. Acta Anaesthesiol Scand. 2020 May;64(5):592-601. doi: 10.1111/aas.13537. Epub 2020 Jan 19.
- Effect of Deliberate Hypotension on Regional Cerebral Oxygen Saturation During Functional Endoscopic Sinus Surgery: A Randomized Controlled TrialLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Cerebral Oxygenation
Active, not recruitingObservational study
BreathinG-induced Myocardial and Cerebral Perfusion in Anxiety Disorders
Generalized Anxiety Disorder, Oxygenation Sensitive CMR
Active, not recruitingObservational study
The Effect of Single Lung Ventilation Duration and Intraoperative Brain Oxygenation on Cognitive Function and Postoperative Pain in Geriatric Patients
Thoracic Anesthesia, Geriatric Anesthesia
Enrolling by invitationObservational study
ETCO₂ Targeting and Cerebral Oxygenation
Airway Reactivity, Hemodynamic Stability During Anesthesia
RecruitingObservational study
NIRS and BIS Monitoring During Cerebral Aneurysm Coiling
Cerebral Aneurysm
Not yet recruitingPhase 4
Effects of Ondansetron Timing During Spinal Anesthesia for Urologic Surgery
Spinal Anesthesia-Induced Hypotension, Cerebral Oxygenation
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.
Mohamed A Daabiss, M.D. principal investigator
Prince Sultan Military Medical City
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 Cerebral Oxygenation, run by Prince Sultan Military Medical City at 1 site in Saudi Arabia.
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 4 inclusion and 10 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 16 May 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 Saudi Arabia. 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?
regional cerebral oxygen saturation (time frame: up to 24 weeks). 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 NCT06325462, 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 16 May 2025.