Comparison of Postoperative Outcome After Sevoflurane and Propofol Anaesthesia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2018-06-30

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.

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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.

Conditions

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Postoperative Cognitive Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sevoflurane

Maintenance of anesthesia with sevoflurane during the cardiac valvular surgery.

Group Type EXPERIMENTAL

sevoflurane

Intervention Type DRUG

Propofol

Maintenance of anesthesia propofol during the cardiac valvular surgery.

Group Type ACTIVE_COMPARATOR

propofol

Intervention Type DRUG

Interventions

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sevoflurane

Intervention Type DRUG

propofol

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes