Comparison of Postoperative Outcome After Sevoflurane and Propofol Anaesthesia

Phase 4

Completed

• Conditions: Postoperative Cognitive Dysfunction
• Interventions: Drug: sevoflurane; Drug: propofol

• Registration Number: NCT02931877
• Lead Sponsor: Xinqiao Hospital of Chongqing

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.

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-10-10
• Study First Submitted QC: 2016-10-12
• Study First Posted: 2016-10-13
• Primary Completion: 2018-04
• Study Completion: 2018-06
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-09
• Last Update Posted: 2018-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sevoflurane	sevoflurane	Maintenance of anesthesia with sevoflurane during the cardiac valvular surgery.
Propofol	propofol	Maintenance of anesthesia propofol during the cardiac valvular surgery.

Primary Outcome Measures

Name	Time	Method
Number of patients with postoperative cognitive dysfunction (POCD)	From 7 days after the surgery to the day of discharge from hospital	POCD is a composite outcome measure

Secondary Outcome Measures

Name	Time	Method
Postoperative delirium (POD)	Up to 7 days after the surgery	POD is evaluated by a commonly used questionnaire

Trial Locations

Locations (3)

Xinan Hospital, Third Military Medical University; 🇨🇳 Chongqing, Chongqing, China

Xinqiao Hospital, Third Military Medical University; 🇨🇳 Chongqing, Chongqing, China

Daping Hospital, Third Military Medical University; 🇨🇳 Chongqing, Chongqing, China