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

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Primary Purpose

Status

Unknown status

Phase

Early Phase 1

Locations

China

Study Type

Interventional

Intervention

Sevoflurane inhalant product

About this trial

This is an interventional other trial for Postoperative Cognitive Dysfunction

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

2nd Affiliated Hospital, School of Medicine, Zhejiang UniversityRecruiting
2nd Affiliated Hospital, School of Medicine, Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Sevoflurane post conditioning group（S1）

The control group（P）

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

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。

Secondary Outcome Measures

Heart rate

Heart rate per minute

Invasive arterial blood pressure

Invasive arterial puncture catheter, continuous arterial pressure monitoring

BIS

bispectral index

PETCO2

Partial pressure End-Tidal Carbon Dioxide

Cerebral oxygen saturation

Full Information

NCT ID

NCT04950205

First Posted

June 14, 2021

Last Updated

July 2, 2021

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

1. Study Identification

Unique Protocol Identification Number

NCT04950205

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Unknown status

Study Start Date

June 1, 2021 (Actual)

Primary Completion Date

December 31, 2022 (Anticipated)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Cognitive Dysfunction, Sevoflurane, Carotid Artery Intima Stripped

7. Study Design

Primary Purpose

Other

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

Participant

Allocation

Randomized

Enrollment

140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Sevoflurane post conditioning group（S1）

Arm Type

Experimental

Arm Description

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

Arm Title

The control group（P）

Arm Type

No Intervention

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Sevoflurane inhalant product

Intervention Description

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

Primary Outcome Measure Information:

Title

Change from the 1 day preoperative to the 1 day postoperative MMSE(Mini-mental State Examination)

Description

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.

Time Frame

the 1st day before the surgery；the 1st day after the surgery

Title

Change from the 1 day preoperative to the 1 day postoperative MoCA(Montreal Cognitive Assessment)

Description

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

Time Frame: the 1st day before the surgery；the 1st day after the surgery

Secondary Outcome Measure Information:

Title

Heart rate

Description

Heart rate per minute

Time Frame