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NCT Number: NCT02931877

Comparison of Postoperative Outcome After Sevoflurane and Propofol Anaesthesia

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.

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Key information

Conditions

Postoperative Cognitive Dysfunction Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Cognitive Complications Postoperative Complications

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Daping Hospital, Third Military Medical University, Chongqing, Chongqing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sevoflurane

Drug

Propofol

Drug

Primary outcomes

  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 outcomes

  1. Postoperative delirium (POD)

    Time frame: Up to 7 days after the surgery

    POD is evaluated by a commonly used questionnaire

Other outcomes

  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

Sponsors and collaborators

Lead sponsor

Xinqiao Hospital of Chongqing

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 13, 2016
Registry last updated
Jul 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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