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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04950205
Other study ID # 2021-0107
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date June 1, 2021
Est. completion date December 31, 2022

Study information

Verified date May 2021
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact Wang Bin, master
Phone +8618806509509
Email 381930860@qq.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 postoperative radiographic changes.


Recruitment information / eligibility

Status Recruiting
Enrollment 140
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 50 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Sevoflurane inhalant product
propofol plus 1% sevoflurane after open Carotid artery until the end of surgery

Locations

Country Name City State
China 2nd Affiliated Hospital, School of Medicine, Zhejiang University HangZhou Zhejiang
China 2nd Affiliated Hospital, School of Medicine, Zhejiang University HangZhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. the 1st day before the surgery;the 1st day after the surgery
Primary 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? Time Frame: the 1st day before the surgery;the 1st day after the surgery
Secondary Heart rate Heart rate per minute 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)
Secondary Invasive arterial blood pressure Invasive arterial puncture catheter, continuous arterial pressure monitoring 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)
Secondary BIS bispectral index 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)
Secondary PETCO2 Partial pressure End-Tidal Carbon Dioxide 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)
Secondary Cerebral oxygen saturation Cerebral oxygen saturation 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)
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