Comparison of Postoperative Outcome After Sevoflurane and Propofol Anaesthesia

Study Overview
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Brief Summary
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As the investigators know, postoperative cognitive dysfunction (POCD) is a fairly well-documented clinical phenomenon, which affect patients' short-term and long-term outcome. Most patients will receive general anesthesia and cardiopulmonary bypass (CPB) during cardiac valvular surgery. Inhalation sevoflurane based and propofol based anesthesia are most commonly used strategy for general anesthesia. At present, it was unknown that which one is better in providing cerebral protection effect for patients undergoing cardiac valvular surgery with CPB. The current study aimed to explore the possible difference.

Detailed Description
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The investigators hypothesize that the incidence of postoperative cognitive dysfunction (POCD) is not different in patients received intravenous anesthetics propofol or sevoflurane for their cardiac valvular surgery. Two groups of general anesthetics (propofol or sevoflurane) are used to explore the possible difference of the postoperative outcome and the incidence of POCD. After cardiac valvular surgery with CPB, patients' POCD tests at 7 days after the surgery, and postoperative delirium, etc., are evaluated by different questionnaires. Also the blood sample of these patients are collected for detection of some stress hormones.

Official Title
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Comparison of Postoperative Outcome and Cognitive Function After Sevoflurane and Propofol Anaesthesia for Cardiac Valvular Surgery With Cardiopulmonary Bypass

Conditions
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Postoperative Cognitive Dysfunction

Intervention / Treatment
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* Drug: sevoflurane
* Drug: propofol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients who receive cardiac valvular surgery 18 to 65 years American society of anesthesiologists classification Ⅱto Ⅲ education level higher than elementary school Exclusion Criteria: Patients are not expected to be alive for longer than 3 months. Mini-mental State Examination (MMSE) score ≤ 23. current use of sedatives or antidepressant history of dementia, psychiatric illness or any diseases of central nervous system. accompanying liver or kidney function deficiency history of some endocrine disease alcoholism and drug dependence patients previously included in this study or currently included in the other clinical study patients who have second surgery during the study period difficult to follow up or patients with poor compliance

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sevoflurane<br>Maintenance of anesthesia with sevoflurane during the cardiac valvular surgery. | Drug: sevoflurane<br> <br> |
| Active Comparator: Propofol<br>Maintenance of anesthesia propofol during the cardiac valvular surgery. | Drug: propofol<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with postoperative cognitive dysfunction (POCD) | POCD is a composite outcome measure | From 7 days after the surgery to the day of discharge from hospital | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative delirium (POD) | POD is evaluated by a commonly used questionnaire | Up to 7 days after the surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sevoflurane, Propofol, Cardiac valvular surgery, Cardiopulmonary bypass, Postoperative cognitive dysfunction