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

Postoperative Cognitive Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04950205
• Other study ID #: 2021-0107
• Status: Recruiting
• Phase: Early Phase 1
• Start date: June 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Wang Bin, master
• Phone: +8618806509509
• Email: 381930860[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Postoperative Cognitive Dysfunction
• Sevoflurane

Intervention

Drug:
• Sevoflurane inhalant product
propofol plus 1% sevoflurane after open Carotid artery until the end of surgery

Locations

Country	Name	City	State
China	2nd Affiliated Hospital, School of Medicine, Zhejiang University	HangZhou	Zhejiang
China	2nd Affiliated Hospital, School of Medicine, Zhejiang University	HangZhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)