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Comparison of Postoperative Outcome After Sevoflurane and Propofol Anaesthesia

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ClinicalTrials.gov Identifier: NCT02931877
Recruitment Status : Completed
First Posted : October 13, 2016
Last Update Posted : July 10, 2018
Sponsor:
Information provided by (Responsible Party):
Hong Li, 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.

Condition or disease Intervention/treatment Phase
Postoperative Cognitive Dysfunction Drug: sevoflurane Drug: propofol Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparison of Postoperative Outcome and Cognitive Function After Sevoflurane and Propofol Anaesthesia for Cardiac Valvular Surgery With Cardiopulmonary Bypass
Actual Study Start Date : October 2016
Actual Primary Completion Date : April 2018
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Postoperative delirium (POD) [ Time Frame: Up to 7 days after the surgery ]
    POD is evaluated by a commonly used questionnaire


Other Outcome Measures:
  1. Degree of increase of stress hormones [ Time Frame: Up to 24 hours after the surgery ]
    Stress hormones include S-100β, Il-6, etc.

  2. Length of ICU stay [ Time Frame: Up to 7 days after the surgery ]
    The time for patient stay in ICU

  3. Length of hospital stay [ Time Frame: Up to 3 months after the surgery ]
    The time for patient stay in hospital



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02931877


Locations
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China, Chongqing
Xinan Hospital, Third Military Medical University
Chongqing, Chongqing, China, 400037
Xinqiao Hospital, Third Military Medical University
Chongqing, Chongqing, China, 400037
Daping Hospital, Third Military Medical University
Chongqing, Chongqing, China, 400042
Sponsors and Collaborators
Xinqiao Hospital of Chongqing
Investigators
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Principal Investigator: Hong Li, M.D. Department of Anesthesiology, Xinqiao Hospital, Third Military Medical University

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Responsible Party: Hong Li, Director, Department of Anesthesiology, Xinqiao Hospital of Chongqing
ClinicalTrials.gov Identifier: NCT02931877     History of Changes
Other Study ID Numbers: Li Hong-Group
First Posted: October 13, 2016    Key Record Dates
Last Update Posted: July 10, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Hong Li, Xinqiao Hospital of Chongqing:
Sevoflurane
Propofol
Cardiac valvular surgery
Cardiopulmonary bypass
Postoperative cognitive dysfunction
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Anesthetics
Propofol
Sevoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Platelet Aggregation Inhibitors
Anesthetics, Inhalation