Carotid EndarterectomyNCT06406842
Association Between Local Cerebral Oxygenation Monitoring and Postoperative Stroke in Carotid Endarterectomy
A study testing Cerebral oxygenation index guided hemodynamics management in people with Carotid Endarterectomy and Cerebral Autoregulation, run by Beijing Tiantan Hospital at 2 sites in China.
Trial summary
Carotid endarterectomy (CEA) is used to treat symptomatic extracranial internal carotid artery stenosis. The occult stroke of CEA patients evaluated by magnetic resonance imaging 3 days after operation was as high as 17%. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Carotid Endarterectomy, Cerebral Autoregulation
- What is being tested?
- Cerebral oxygenation index guided hemodynamics management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 560 participants
- Where
- 2 sitesChina
- Study dates
- 8 Jul 2024to Dec 2026
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for elective carotid endarterectomy
- ASA Ⅱ or Ⅲ
- aged 18-80 years old
Who cannot join
- preoperative moderate and severe cognitive impairment
- preoperative psychotropic medication history within one year
- history of neurosurgery
- have speech or language impairments
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100053
Lei Zhao, 13811035886, zhaoalei@sina.com
- Recruiting
Beijing Tian Tan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070
Yuming Peng, 8610-59976658, florapym766@163.com
About this study
Official title: Perioperative Application of Hemodynamic Management Based on Regional Cerebral Oxygen Saturation Monitoring of Cerebral Autoregulation in Carotid Endarterectomy
Carotid endarterectomy (CEA) is used to treat symptomatic extracranial internal carotid artery stenosis. The occult stroke of CEA patients evaluated by magnetic resonance imaging 3 days after operation was as high as 17%. Cerebral blood flow autoregulation (CA) is the ability of the brain to maintain the relative stability of cerebral blood flow, and cerebral oxygen index (COx) can be used to reflect CA. A negative value of cerebral oxygen index or a value near zero indicates that CA is complete, and cerebral oxygen index close to 1 indicates that CA has lost its ability. In theory, real-time monitoring of CA function by cerebral oxygen index and individualized management strategy with this goal can potentially reduce perioperative ischemic brain injury. The purpose of this study is to explore the influence of the management strategy of monitoring CA function based on regional cerebral oxygen saturation on the postoperative neurological complications of CEA patients.
- Conditions
- Carotid Endarterectomy, Cerebral Autoregulation
- Being tested
- Cerebral oxygenation index guided hemodynamics management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerebral oxygenation index guided hemodynamics managementOther
In the autoregulation group, anesthesiologist will maintain that the cerebral oxygen index value below 0.3. If cerebral oxygen index exceeds the threshold, norepinephrine or phenylephrine will be infused continuously, or arterial partial pressure of oxygen or arterial partial pressure of carbon dioxide will be adjusted to increase regional cerebral oxygen saturation.
| Study group | Role | What they receive |
|---|---|---|
| The autoregulation group | Experimental | In the autoregulation group, anesthesiologist will maintain that the cerebral oxygen index value below 0.3. If cerebral oxygen index exceeds the threshold, Norepinephrine or Phenylephrine will be infused continuously, or arterial partial pressure of oxygen or arterial partial pressure of carbon dioxide will be adjusted to increase regional cerebral oxygen saturation. Receives: Other: Cerebral oxygenation index guided hemodynamics management |
| The routine group | No intervention | In the routine group, the screen of the collection monitor will be covered by a black cloth . Anesthesiologist will not have access to the patient's cerebral oxygen index value. Anesthesiologist will strive to maintain mean arterial pressure within a ± 20% range of their baseline mean arterial pressure. Outside of this range, the same vasoactive drugs will be employed for modulation. Additionally, anaesthesiologists will maintain PaCO₂ within the range of 35-45 mmHg and set the fraction of inspired oxygen at 50%. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of postoperative cerebral ischemic events
Our primary outcome will be the incidence of new ischemic brain injury within 3 days after surgery, defined as new infarct focus detected by magnetic resonance imaging diffusion-weighted imaging or computed tomography, with or without new-onset limb weakness, paresthesia, or language abnormalities. Diffusion-weighted imaging sequences will be used at each scan to detect acute ischemic brain lesions.
Measured: postoperative 3 day
Secondary outcomes (4)
The incidence of postoperative delirium
The incidence and severity of postoperative delirium will be assessed during the first 3 days after surgery. Delirium will be assessed twice daily between 8:00-10:00 and 18:00-20:00 in ward patients with the Richmond Agitation Sedation Scale (RASS) and the 3 min diagnostic interview for CAM (3D-CAM). ICU patients will be similarly assessed with RASS and the confusion assessment method for ICU (CAM-ICU). Any positive 3D-CAM or CAM-ICU assessment will be considered evidence of delirium.
Measured: The first 3 days after surgery
Basic Cognition Assessment
Postoperative basic cognitive function will be assessed by Mini-mental State Examination. This will be rated on a scale from 0 to 30, higher cores corresponded to higher levels of cognitive function.
Measured: The day before surgery and postoperative day 4 or 5
Advanced Cognitive Assessment
Postoperative basic cognitive function will be assessed by Montreal Cognitive Assessment-Basic Examination. This will be rated on a scale from 0 to 30, higher cores corresponded to higher levels of cognitive function.
Measured: The day before surgery and postoperative day 4 or 5
Pain assessment
Pain scores will be recorded at rest and during movement . The pain was rated on a scale from 0 to 10, where 0 indicated no pain and 10 indicated the worst possible pain. Higher scores corresponded to higher levels of pain.
Measured: At 24, 48, and 72 hours post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start8 Jul 2024
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
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 Carotid EndarterectomyStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuming Peng, Beijing Tiantan Hospital
- Investigators
- Yuming MD Peng, Ph.D, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06406842
- Sponsor's protocol ID
- 202422047
- Status last verified
- Sep 2025
- First submitted
- 6 May 2024
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li M, Yin X, Liang C, Tao C, Yan Q, Zeng M, Li S, Sessler DI, Wang R, Zhao L, Peng Y. Effect of perioperative haemodynamic management based on cerebral autoregulation monitored by Cerebral Oximetry Index during carotid endarterectomy: protocol of a randomised trial. BMJ Open. 2025 Jun 19;15(6):e094156. doi: 10.1136/bmjopen-2024-094156.
PubMed 40537236
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Application of Hemodynamic Management Based on Regional Cerebral Oxygen Saturation Monitoring of Cerebral Autoregulation in Carotid Endarterectomy
- ClinicalTrials.gov ID
- NCT06406842
- Acronym / sponsor ID
- 202422047
- Conditions
- Carotid Endarterectomy, Cerebral Autoregulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 560 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 8 Jul 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 9 May 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.
Carotid endarterectomy (CEA) is used to treat symptomatic extracranial internal carotid artery stenosis. The occult stroke of CEA patients evaluated by magnetic resonance imaging 3 days after operation was as high as 17%. Cerebral blood flow autoregulation (CA) is the ability of the brain to maintain the relative stability of cerebral blood flow, and cerebral oxygen index (COx) can be used to reflect CA. A negative value of cerebral oxygen index or a value near zero indicates that CA is complete, and cerebral oxygen index close to 1 indicates that CA has lost its ability. In theory, real-time monitoring of CA function by cerebral oxygen index and individualized management strategy with this goal can potentially reduce perioperative ischemic brain injury. The purpose of this study is to explore the influence of the management strategy of monitoring CA function based on regional cerebral oxygen saturation on the postoperative neurological complications of CEA patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The autoregulation group | Experimental | Other: Cerebral oxygenation index guided hemodynamics managementIn the autoregulation group, anesthesiologist will maintain that the cerebral oxygen index value below 0.3. If cerebral oxygen index exceeds the threshold, Norepinephrine or Phenylephrine will be infused continuously, or arterial partial pressure of oxygen or arterial partial pressure of carbon dioxide will be adjusted to increase regional cerebral oxygen saturation. |
| The routine group | No intervention | –In the routine group, the screen of the collection monitor will be covered by a black cloth . Anesthesiologist will not have access to the patient's cerebral oxygen index value. Anesthesiologist will strive to maintain mean arterial pressure within a ± 20% range of their baseline mean arterial pressure. Outside of this range, the same vasoactive drugs will be employed for modulation. Additionally, anaesthesiologists will maintain PaCO₂ within the range of 35-45 mmHg and set the fraction of inspired oxygen at 50%. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients scheduled for elective carotid endarterectomy
- ASA Ⅱ or Ⅲ
- aged 18-80 years old
Key exclusion criteria (4 listed)
- preoperative moderate and severe cognitive impairment
- preoperative psychotropic medication history within one year
- history of neurosurgery
- have speech or language impairments
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 |
|---|---|---|
| Cerebral oxygenation index guided hemodynamics managementIn the autoregulation group, anesthesiologist will maintain that the cerebral oxygen index value below 0.3. If cerebral oxygen index exceeds the threshold, norepinephrine or phenylephrine will be infused continuously, or arterial partial pressure of oxygen or arterial partial pressure of carbon dioxide will be adjusted to increase regional cerebral oxygen saturation. | Other | The autoregulation group |
Primary outcome
The incidence of postoperative cerebral ischemic events
Time frame: postoperative 3 day
Our primary outcome will be the incidence of new ischemic brain injury within 3 days after surgery, defined as new infarct focus detected by magnetic resonance imaging diffusion-weighted imaging or computed tomography, with or without new-onset limb weakness, paresthesia, or language abnormalities. Diffusion-weighted imaging sequences will be used at each scan to detect acute ischemic brain lesions.
4 secondary outcomes
The incidence of postoperative delirium
Time frame: The first 3 days after surgery
Basic Cognition Assessment
Time frame: The day before surgery and postoperative day 4 or 5
Advanced Cognitive Assessment
Time frame: The day before surgery and postoperative day 4 or 5
Pain assessment
Time frame: At 24, 48, and 72 hours post-surgery
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 8 Sep 2025.
- Derived from this study: PubMed 40537236Li M, Yin X, Liang C, Tao C, Yan Q, Zeng M, Li S, Sessler DI, Wang R, Zhao L, Peng Y. Effect of perioperative haemodynamic management based on cerebral autoregulation monitored by Cerebral Oximetry Index during carotid endarterectomy: protocol of a randomised trial. BMJ Open. 2025 Jun 19;15(6):e094156. doi: 10.1136/bmjopen-2024-094156.
- Individual participant dataSharing planned: No
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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.
Yuming MD Peng, Ph.D principal investigator
Beijing Tiantan Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cerebral oxygenation index guided hemodynamics management in people with Carotid Endarterectomy and Cerebral Autoregulation, run by Beijing Tiantan Hospital at 2 sites in China.
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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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 Yuming MD Peng, Ph.D (8610-59976658, florapym766@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of postoperative cerebral ischemic events (time frame: postoperative 3 day). 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 NCT06406842, 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 8 Sep 2025.