Postoperative Cognitive DysfunctionEarly Phase 1NCT04950205
Influence of Postoperative Cognitive Function in Patients With Sevoflurane Postconditioning on Carotid Intima Stripped
A Early Phase 1 study testing Sevoflurane inhalant product in people with Postoperative Cognitive Dysfunction and Sevoflurane, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 2 sites in China.
Trial summary
Brief summary: In order to get a better clinical plan for brain protection during perioperative anesthesia for high-risk patients - carotid intima stripped. We observing the hemodynamic changes of sevoflurane post-treatment in carotid intima stripped, the comparison of postoperative cognitive function and… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Postoperative Cognitive Dysfunction, Sevoflurane, Carotid Artery Intima Stripped
- What is being tested?
- Sevoflurane inhalant product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jun 2021to 31 Dec 2022
- Phase
- Early Phase 1
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists（ASA）：II-III
- Aged between 40 and 80 years
- Patients scheduled for surgery of Carotid stenosis under general anaesthesia
Who cannot join
- Has a history of mental illness can't cooperate,
- Serious heart block or cardiac decompensation or severe sinus slow (HR < 50 times/min),
- The abnormal nerve monitoring in operation, MMES preoperative score < 20 points,
- Any rescue unexpected occurred during the operation
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang
Wang Bin, Master, +8618806509509, 381930860@qq.com
- Recruiting
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang
Wang Bin, Master
About this study
Official title: The Influence of Postoperative Cognitive Function in Patients With Sevoflurane Postconditioning on Carotid Intima Stripped
Brief summary: In order to get a better clinical plan for brain protection during perioperative anesthesia for high-risk patients - carotid intima stripped. We observing the hemodynamic changes of sevoflurane post-treatment in carotid intima stripped, the comparison of postoperative cognitive function and postoperative radiographic changes.
- Being tested
- Sevoflurane inhalant product
- Medical subject headings
- Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sevoflurane inhalant productDrug
propofol plus 1% sevoflurane after open Carotid artery until the end of surgery
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane post conditioning group（S1） | Experimental | propofol：0.05～0.1mg/(kg.min) maintain throughout the whole surgery ,1% sevoflurane plus after open Carotid artery until the end of surgery Receives: Drug: Sevoflurane inhalant product |
| The control group（P） | No intervention | propofol：0.05～0.1mg/(kg.min) maintain throughout the whole surgery without sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from the 1 day preoperative to the 1 day postoperative MMSE(Mini-mental State Examination)
Screening scale of cognitive function。The highest score is 30 points, 27 to 30 were divided into normal, less than 27 divided into cognitive dysfunction。But is not sensitive in the early identification of dementia, especially in mild cognitive impairment is poorer.
Measured: the 1st day before the surgery；the 1st day after the surgery
Change from the 1 day preoperative to the 1 day postoperative MoCA(Montreal Cognitive Assessment)
Screening scale of cognitive function。The highest score is 30 points，Add 1 score, education the following subjects in less than 12 years。Total score less than 26 divided into cognitive dysfunction。Compared with MMSE, more sensitive to mild dementia。
Measured: Time Frame: the 1st day before the surgery；the 1st day after the surgery
Secondary outcomes (5)
Heart rate
Heart rate per minute
Measured: Ten minutes before induction（T0) ,Intraoperative (Before the carotid artery occlusion（T1）), Intraoperative (before open the Carotid artery（T2)，At the end of the surgery when the surgeon completed sewing skin（T3），the 24 hours after the operation（T4）
Invasive arterial blood pressure
Invasive arterial puncture catheter, continuous arterial pressure monitoring
Measured: Ten minutes before induction（T0) ,Intraoperative (Before the carotid artery occlusion（T1）), Intraoperative (before open the Carotid artery（T2)，At the end of the surgery when the surgeon completed sewing skin（T3），the 24 hours after the operation（T4）
BIS
bispectral index
Measured: Ten minutes before induction（T0) ,Intraoperative (Before the carotid artery occlusion（T1）), Intraoperative (before open the Carotid artery（T2)，At the end of the surgery when the surgeon completed sewing skin（T3），the 24 hours after the operation（T4）
PETCO2
Partial pressure End-Tidal Carbon Dioxide
Measured: Ten minutes before induction（T0) ,Intraoperative (Before the carotid artery occlusion（T1）), Intraoperative (before open the Carotid artery（T2)，At the end of the surgery when the surgeon completed sewing skin（T3），the 24 hours after the operation（T4）
Cerebral oxygen saturation
Cerebral oxygen saturation
Measured: Ten minutes before induction（T0) ,Intraoperative (Before the carotid artery occlusion（T1）), Intraoperative (before open the Carotid artery（T2)，At the end of the surgery when the surgeon completed sewing skin（T3），the 24 hours after the operation（T4）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2021
- Study start1 Jun 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (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 Postoperative Cognitive DysfunctionStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04950205
- Sponsor's protocol ID
- 2021-0107
- Status last verified
- May 2021
- First submitted
- 14 Jun 2021
- Last updated
- 6 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang B, Li S, Wang C, Zhu J, Jin Y, Sun D, Lang J. Effect of sevoflurane post-conditioning on postoperative cognitive function in carotid endarterectomy patients: a randomized, double-blind, controlled trial. Front Med (Lausanne). 2025 Dec 8;12:1716370. doi: 10.3389/fmed.2025.1716370. eCollection 2025.
PubMed 41438154
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Postoperative Cognitive Function in Patients With Sevoflurane Postconditioning on Carotid Intima Stripped
- ClinicalTrials.gov ID
- NCT04950205
- Acronym / sponsor ID
- 2021-0107
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 6 Jul 2021 (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.
Brief summary: In order to get a better clinical plan for brain protection during perioperative anesthesia for high-risk patients - carotid intima stripped. We observing the hemodynamic changes of sevoflurane post-treatment in carotid intima stripped, the comparison of postoperative cognitive function and postoperative radiographic changes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane post conditioning group（S1） | Experimental | Drug: Sevoflurane inhalant productpropofol：0.05～0.1mg/(kg.min) maintain throughout the whole surgery ,1% sevoflurane plus after open Carotid artery until the end of surgery |
| The control group（P） | No intervention | –propofol：0.05～0.1mg/(kg.min) maintain throughout the whole surgery without sevoflurane |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists（ASA）：II-III
- Aged between 40 and 80 years
- Patients scheduled for surgery of Carotid stenosis under general anaesthesia
Key exclusion criteria (4 listed)
- Has a history of mental illness can't cooperate,
- Serious heart block or cardiac decompensation or severe sinus slow (HR < 50 times/min),
- The abnormal nerve monitoring in operation, MMES preoperative score < 20 points,
- Any rescue unexpected occurred during the operation
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 |
|---|---|---|
| Sevoflurane inhalant productpropofol plus 1% sevoflurane after open Carotid artery until the end of surgery | Drug | Sevoflurane post conditioning group（S1） |
Primary outcome
Change from the 1 day preoperative to the 1 day postoperative MMSE(Mini-mental State Examination)
Time frame: the 1st day before the surgery；the 1st day after the surgery
Screening scale of cognitive function。The highest score is 30 points, 27 to 30 were divided into normal, less than 27 divided into cognitive dysfunction。But is not sensitive in the early identification of dementia, especially in mild cognitive impairment is poorer.
Change from the 1 day preoperative to the 1 day postoperative MoCA(Montreal Cognitive Assessment)
Time frame: Time Frame: the 1st day before the surgery；the 1st day after the surgery
Screening scale of cognitive function。The highest score is 30 points，Add 1 score, education the following subjects in less than 12 years。Total score less than 26 divided into cognitive dysfunction。Compared with MMSE, more sensitive to mild dementia。
5 secondary outcomes
Heart rate
Time frame: Ten minutes before induction（T0) ,Intraoperative (Before the carotid artery occlusion（T1）), Intraoperative (before open the Carotid artery（T2)，At the end of the surgery when the surgeon completed sewing skin（T3），the 24 hours after the operation（T4）
Invasive arterial blood pressure
Time frame: Ten minutes before induction（T0) ,Intraoperative (Before the carotid artery occlusion（T1）), Intraoperative (before open the Carotid artery（T2)，At the end of the surgery when the surgeon completed sewing skin（T3），the 24 hours after the operation（T4）
BIS
Time frame: Ten minutes before induction（T0) ,Intraoperative (Before the carotid artery occlusion（T1）), Intraoperative (before open the Carotid artery（T2)，At the end of the surgery when the surgeon completed sewing skin（T3），the 24 hours after the operation（T4）
PETCO2
Time frame: Ten minutes before induction（T0) ,Intraoperative (Before the carotid artery occlusion（T1）), Intraoperative (before open the Carotid artery（T2)，At the end of the surgery when the surgeon completed sewing skin（T3），the 24 hours after the operation（T4）
Cerebral oxygen saturation
Time frame: Ten minutes before induction（T0) ,Intraoperative (Before the carotid artery occlusion（T1）), Intraoperative (before open the Carotid artery（T2)，At the end of the surgery when the surgeon completed sewing skin（T3），the 24 hours after the operation（T4）
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2021.
- Derived from this study: PubMed 41438154Wang B, Li S, Wang C, Zhu J, Jin Y, Sun D, Lang J. Effect of sevoflurane post-conditioning on postoperative cognitive function in carotid endarterectomy patients: a randomized, double-blind, controlled trial. Front Med (Lausanne). 2025 Dec 8;12:1716370. doi: 10.3389/fmed.2025.1716370. eCollection 2025.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Sevoflurane inhalant product in people with Postoperative Cognitive Dysfunction and Sevoflurane, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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: status not confirmed, as of the sponsor's last update on 6 Jul 2021. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wang Bin, master (+8618806509509, 381930860@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from the 1 day preoperative to the 1 day postoperative MMSE(Mini-mental State Examination) (time frame: the 1st day before the surgery；the 1st day after the surgery). The study lists 2 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 NCT04950205, 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 6 Jul 2021.