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

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04950205
Collaborator
(none)
140
Enrollment
2
Locations
2
Arms
19
Anticipated Duration (Months)
70
Patients Per Site
3.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Sevoflurane inhalant product
 Early Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
140 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Single (Participant)
Primary Purpose:
Other
Official Title:
The Influence of Postoperative Cognitive Function in Patients With Sevoflurane Postconditioning on Carotid Intima Stripped
Actual Study Start Date :
Jun 1, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

Drug: Sevoflurane inhalant product
propofol plus 1% sevoflurane after open Carotid artery until the end of surgery
No Intervention: The control group（P）

propofol：0.05～0.1mg/(kg.min) maintain throughout the whole surgery without sevoflurane

Outcome Measures

Primary Outcome Measures

  1. 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 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.

  2. 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 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。

Secondary Outcome Measures

  1. 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）]

    Heart rate per minute

  2. 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）]

    Invasive arterial puncture catheter, continuous arterial pressure monitoring

  3. 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）]

    bispectral index

  4. 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）]

    Partial pressure End-Tidal Carbon Dioxide

  5. 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）]

    Cerebral oxygen saturation

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 80 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 2nd Affiliated Hospital, School of Medicine, Zhejiang University HangZhou Zhejiang China
2 2nd Affiliated Hospital, School of Medicine, Zhejiang University HangZhou Zhejiang China

Sponsors and Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier:
NCT04950205
Other Study ID Numbers:
  • 2021-0107
First Posted:
Jul 6, 2021
Last Update Posted:
Jul 6, 2021
Last Verified:
May 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Postoperative Cognitive Complications
Cognitive Dysfunction
Sevoflurane

Study Results

No Results Posted as of Jul 6, 2021