Clinical trial NCT02931877: Comparison of Postoperative Outcome After Sevoflurane and Propofol Anaesthesia
Official title: Comparison of Postoperative Outcome and Cognitive Function After Sevoflurane and Propofol Anaesthesia for Cardiac Valvular Surgery With Cardiopulmonary Bypass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Cognitive Dysfunction
Keywords: Sevoflurane
Propofol
Cardiac valvular surgery
Cardiopulmonary bypass
Postoperative cognitive dysfunction
Lead sponsor: Xinqiao Hospital of Chongqing
Sponsor class: OTHER
First posted: 2016-10-13
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with postoperative cognitive dysfunction (POCD)
timeFrame: From 7 days after the surgery to the day of discharge from hospital
Secondary outcomes:
measure: Postoperative delirium (POD)
timeFrame: Up to 7 days after the surgery
Other outcomes:
measure: Degree of increase of stress hormones
timeFrame: Up to 24 hours after the surgery
measure: Length of ICU stay
timeFrame: Up to 7 days after the surgery
measure: Length of hospital stay
timeFrame: Up to 3 months after the surgery
Locations:
city: Chongqing
country: China
facility: Xinan Hospital, Third Military Medical University
state: Chongqing
city: Chongqing
country: China
facility: Xinqiao Hospital, Third Military Medical University
state: Chongqing
city: Chongqing
country: China
facility: Daping Hospital, Third Military Medical University
state: Chongqing
Study officials:
affiliation: Department of Anesthesiology, Xinqiao Hospital, Third Military Medical University
name: Hong Li, M.D.
role: PRINCIPAL_INVESTIGATOR
References: