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Clinical Trials/NCT04950205
NCT04950205
Unknown
Early Phase 1

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

Second Affiliated Hospital, School of Medicine, Zhejiang University1 site in 1 country140 target enrollmentJune 1, 2021

Overview

Phase
Early Phase 1
Intervention
Sevoflurane inhalant product
Conditions
Postoperative Cognitive Dysfunction
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Enrollment
140
Locations
1
Primary Endpoint
Change from the 1 day preoperative to the 1 day postoperative MoCA(Montreal Cognitive Assessment)
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2021
End Date
December 31, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

Sevoflurane post conditioning group(S1)

propofol:0.05~0.1mg/(kg.min) maintain throughout the whole surgery ,1% sevoflurane plus after open Carotid artery until the end of surgery

Intervention: Sevoflurane inhalant product

Outcomes

Primary Outcomes

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。

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.

Secondary Outcomes

  • 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))
  • PETCO2(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(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(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))
  • Heart rate(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))

Study Sites (1)

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