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

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Cognitive Impairment, Mild

Intervention / Treatment
-----------------
* Drug: Propofol
* Drug: Sevoflurane


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Propofol<br>administrated Target Controlled Infusion （TCI）of propofol （Cp 2.0 2.5μg/ml ）for maintaining | Drug: Propofol<br>* Propofol is the most common clinical anesthetics.<br>|
| Experimental: 1.2 μg/ml Propofol<br>administrated Target Controlled Infusion （TCI）of propofol （Cp 1.2 μg/ml ）combined with appropriate sevoflurane for maintaining | Drug: Propofol<br>* Propofol is the most common clinical anesthetics.<br>Drug: Sevoflurane<br>* Sevoflurane is the most common clinical anesthetics.<br>|
| Experimental: 0.6 μg/ml Propofol<br>administrated Target Controlled Infusion （TCI）of propofol （Cp 0.6 μg/ml ）combined with appropriate sevoflurane for maintaining | Drug: Propofol<br>* Propofol is the most common clinical anesthetics.<br>Drug: Sevoflurane<br>* Sevoflurane is the most common clinical anesthetics.<br>|
| Experimental: Sevoflurane<br>administrated 1.3 minimum alveolar concentration（MAC ） sevoflurane for maintaining | Drug: Sevoflurane<br>* Sevoflurane is the most common clinical anesthetics.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of clinically cognitive function decline ：Apolipoprotein J（ApoJ） | Measurement by ELISA kit | Change from Baseline Apolipoprotein J at 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of clinically cognitive function decline ：Soluble CD14（sCD14） | Estimating by ELISA kit | Change from Baseline Soluble CD14 at 7 days | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mild cognitive impairment