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Comparison of Postoperative Outcome After Sevoflurane and Propofol Anaesthesia

A

Army Medical University of People's Liberation Army

Status and phase

Completed
Phase 4

Conditions

Postoperative Cognitive Dysfunction

Treatments

Drug: propofol
Drug: sevoflurane

Study type

Interventional

Funder types

Other

Identifiers

NCT02931877
Li Hong-Group

Details and patient eligibility

About

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.

Full 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.

Enrollment

300 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

300 participants in 2 patient groups

Sevoflurane
Experimental group
Description:
Maintenance of anesthesia with sevoflurane during the cardiac valvular surgery.
Treatment:
Drug: sevoflurane
Propofol
Active Comparator group
Description:
Maintenance of anesthesia propofol during the cardiac valvular surgery.
Treatment:
Drug: propofol

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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