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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Cognitive Dysfunction; Sevoflurane; Carotid Artery Intima Stripped
• Intervention / Treatment: Drug: Sevoflurane inhalant product

• Study Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Wang Bin, Master; Phone Number: +8618806509509; Email: 381930860@qq.com

Study Locations

• China
  • Zhejiang
    • HangZhou, Zhejiang, China
      • Recruiting
      • 2nd Affiliated Hospital, School of Medicine, Zhejiang University
      • Contact: Wang Bin, Master

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	Heart rate per minute	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	Invasive arterial puncture catheter, continuous arterial pressure monitoring	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	bispectral index	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	Partial pressure End-Tidal Carbon Dioxide	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	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）

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: June 14, 2021
• First Submitted That Met QC Criteria: July 2, 2021
• First Posted (Actual): July 6, 2021

Study Record Updates

• Last Update Posted (Actual): July 6, 2021
• Last Update Submitted That Met QC Criteria: July 2, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Postoperative Complications; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Postoperative Cognitive Complications; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Anesthetics, Inhalation; Sevoflurane
• Other Study ID Numbers: 2021-0107

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No