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

NCT04950205 | Unknown Early Phase 1

• 1 other identifier: 2021-0107
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 2

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.

Conditions

Postoperative Cognitive Dysfunction; Sevoflurane; Carotid Artery Intima Stripped

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• 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）

• 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）

• 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）

• 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）

Study Arms (2)

Sevoflurane post conditioning group（S1）

EXPERIMENTAL

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

The control group（P）

NO INTERVENTION

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

Interventions

Sevoflurane inhalant product DRUG

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

Sevoflurane post conditioning group（S1）

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists（ASA）：II-III
• Aged between 40 and 80 years
• Patients scheduled for surgery of Carotid stenosis under general anaesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (2)

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

RECRUITING

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

RECRUITING

Related Publications (1)

• Wang B, Li S, Wang C, Zhu J, Jin Y, Sun D, Lang J. Effect of sevoflurane post-conditioning on postoperative cognitive function in carotid endarterectomy patients: a randomized, double-blind, controlled trial. Front Med (Lausanne). 2025 Dec 8;12:1716370. doi: 10.3389/fmed.2025.1716370. eCollection 2025.

  PMID: 41438154 DERIVED

MeSH Terms

Conditions

Postoperative Cognitive Complications

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Wang Bin, master

CONTACT

+8618806509509; 381930860@qq.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: July 6, 2021
• Study Start: June 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: July 6, 2021

Record last verified: 2021-05

Locations

CN (2)