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Clinical Trials/NCT02931877
NCT02931877
Completed
Phase 4

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

Xinqiao Hospital of Chongqing3 sites in 1 country300 target enrollmentOctober 2016

Overview

Phase
Phase 4
Intervention
sevoflurane
Conditions
Postoperative Cognitive Dysfunction
Sponsor
Xinqiao Hospital of Chongqing
Enrollment
300
Locations
3
Primary Endpoint
Number of patients with postoperative cognitive dysfunction (POCD)
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2016
End Date
June 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Xinqiao Hospital of Chongqing
Responsible Party
Principal Investigator
Principal Investigator

Hong Li

Director, Department of Anesthesiology

Xinqiao Hospital of Chongqing

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 ≤
  • 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

Arms & Interventions

Sevoflurane

Maintenance of anesthesia with sevoflurane during the cardiac valvular surgery.

Intervention: sevoflurane

Propofol

Maintenance of anesthesia propofol during the cardiac valvular surgery.

Intervention: propofol

Outcomes

Primary Outcomes

Number of patients with postoperative cognitive dysfunction (POCD)

Time Frame: From 7 days after the surgery to the day of discharge from hospital

POCD is a composite outcome measure

Secondary Outcomes

  • Postoperative delirium (POD)(Up to 7 days after the surgery)

Study Sites (3)

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