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

Early Phase 1

• Conditions: Carotid Artery Intima Stripped; Sevoflurane; Postoperative Cognitive Dysfunction
• Interventions: Drug: Sevoflurane inhalant product

• Registration Number: NCT04950205
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-05
• Study Start: 2021-06-01
• Study First Submitted: 2021-06-14
• Study First Submitted QC: 2021-07-02
• Last Update Submitted: 2021-07-02
• Study First Posted: 2021-07-06
• Last Update Posted: 2021-07-06
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sevoflurane post conditioning group（S1）	Sevoflurane inhalant product	propofol：0.05～0.1mg/(kg.min) maintain throughout the whole surgery ,1% sevoflurane plus after open Carotid artery until the end of surgery

Primary Outcome Measures

Name	Time	Method
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。
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.

Secondary Outcome Measures

Name	Time	Method
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
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
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
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
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

Trial Locations

Locations (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University; 🇨🇳 HangZhou, Zhejiang, China