Comparison of Postoperative Outcome After Sevoflurane and Propofol Anaesthesia

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Cognitive Dysfunction
• Intervention / Treatment: Drug: sevoflurane; Drug: propofol

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 Type: Interventional
• Enrollment (Actual): 300
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400037
      • XinQiao Hospital, Third Military Medical University
    • Chongqing, Chongqing, China, 400042
      • Daping Hospital, Third Military Medical University
    • Chongqing, Chongqing, China, 400037
      • Xinan Hospital, Third Military Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of increase of stress hormones	Stress hormones include S-100β, Il-6, etc.	Up to 24 hours after the surgery
Length of ICU stay	The time for patient stay in ICU	Up to 7 days after the surgery
Length of hospital stay	The time for patient stay in hospital	Up to 3 months after the surgery

Collaborators and Investigators

• Sponsor: Xinqiao Hospital of Chongqing

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): April 1, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: October 10, 2016
• First Submitted That Met QC Criteria: October 12, 2016
• First Posted (Estimate): October 13, 2016

Study Record Updates

• Last Update Posted (Actual): July 10, 2018
• Last Update Submitted That Met QC Criteria: July 9, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Propofol; Postoperative cognitive dysfunction; Sevoflurane; Cardiopulmonary bypass; Cardiac valvular surgery
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Postoperative Complications; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Postoperative Cognitive Complications; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Hypnotics and Sedatives; Anesthetics, Inhalation; Propofol; Sevoflurane
• Other Study ID Numbers: Li Hong-Group

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED