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Influence of Postoperative Cognitive Function in Patients With Sevoflurane Postconditioning on Carotid Intima Stripped

The Influence of Postoperative Cognitive Function in Patients With Sevoflurane Postconditioning on Carotid Intima Stripped

Status
UNKNOWN
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04950205
Enrollment
140
Registered
2021-07-06
Start date
2021-06-01
Completion date
2022-12-31
Last updated
2021-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Cognitive Dysfunction, Sevoflurane, Carotid Artery Intima Stripped

Brief 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 postoperative radiographic changes.

Interventions

propofol plus 1% sevoflurane after open Carotid artery until the end of surgery

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* American Society of Anesthesiologists(ASA):II-III * Aged between 40 and 80 years * Patients scheduled for surgery of Carotid stenosis under general anaesthesia

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Change from the 1 day preoperative to the 1 day postoperative MMSE(Mini-mental State Examination)the 1st day before the surgery;the 1st day after the surgeryScreening 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: the 1st day before the surgery;the 1st day after the surgeryScreening 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。

Secondary

MeasureTime frameDescription
BISTen 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)bispectral index
Heart rateTen 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)Heart rate per minute
Cerebral oxygen saturationTen 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
PETCO2Ten 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)Partial pressure End-Tidal Carbon Dioxide
Invasive arterial blood pressureTen 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 puncture catheter, continuous arterial pressure monitoring

Countries

China

Contacts

Primary ContactWang Bin, master
381930860@qq.com+8618806509509

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026