Appropriate Compatibility of Propofol and Sevoflurane for Orthopaedic Surgery of Patients With MCI

Cognitive Impairment, Mild Clinical Trial

— MCI  

Official title:

The Appropriate Compatibility of Propofol and Sevoflurane for Orthopaedic Surgery of Patients With Mild Cognitive Impairment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03165396
• Other study ID #: szxlcyj-chen
• Status: Recruiting
• Phase: N/A
• Start date: November 10, 2016
• Est. completion date: November 1, 2018

Study information

• Verified date: May 2017
• Source: The Third Central Clinical College of Tianjin Medical University
• Contact: Haiyun Wang
• Phone: 86-13752211206
• Email: why[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

According to the inclusion and exclusion criteria, elderly patients undergoing elective orthopedic surgery were randomly divided into four groups. The different combinations of propofol and sevoflurane were used in the four groups: 1 day before surgery, after patients become wide-awake, and 3 days, 7 days, and 3 months after surgery, the patient's cognitive function was evaluated using a professional cognitive scale and other indicators. Finally, statistical analysis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 1, 2018
• Est. primary completion date: August 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

Inclusion Criteria:

• Elective orthopaedic surgery

• American Society of Anesthesiologists physical status: II

Exclusion Criteria:

• Neurological diseases that may affect cognitive function (e.g., subdural hematoma)

• Hypothyroidism

• Alcoholic dementia

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment, Mild

Intervention

Drug:
• Propofol
Propofol is the most common clinical anesthetics.
• Sevoflurane
Sevoflurane is the most common clinical anesthetics.

Locations

Country	Name	City	State
China	Third Central Hospital of Tianjin	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
The Third Central Clinical College of Tianjin Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence of clinically cognitive function decline :Apolipoprotein J(ApoJ)	Measurement by ELISA kit	Change from Baseline Apolipoprotein J at 7 days
Secondary	Evidence of clinically cognitive function decline :Soluble CD14(sCD14)	Estimating by ELISA kit	Change from Baseline Soluble CD14 at 7 days
Secondary	Mini mental Examination(MMSE)	A questionnaires is used to assess the cognitive function of patients in clinical.Total range was 0~30,?27 were considered as cognitive function decline	preoperative 24 hours , 7 days post surgery
Secondary	Montreal Cognitive Assessment(MoCA)	A questionnaires is used to assess the cognitive function of patients in clinical.Total range was 0~30,?27 were considered as cognitive function decline.	preoperative 24 hours ,7 days post surgery