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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02931877
Enrollment
300
Registered
2016-10-13
Start date
2016-10-31
Completion date
2018-06-30
Last updated
2018-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Cognitive Dysfunction

Keywords

Sevoflurane, Propofol, Cardiac valvular surgery, Cardiopulmonary bypass, Postoperative cognitive dysfunction

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.

Interventions

DRUGsevoflurane
DRUGpropofol

Sponsors

Xinqiao Hospital of Chongqing
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Number of patients with postoperative cognitive dysfunction (POCD)From 7 days after the surgery to the day of discharge from hospitalPOCD is a composite outcome measure

Secondary

MeasureTime frameDescription
Postoperative delirium (POD)Up to 7 days after the surgeryPOD is evaluated by a commonly used questionnaire

Other

MeasureTime frameDescription
Degree of increase of stress hormonesUp to 24 hours after the surgeryStress hormones include S-100β, Il-6, etc.
Length of ICU stayUp to 7 days after the surgeryThe time for patient stay in ICU
Length of hospital stayUp to 3 months after the surgeryThe time for patient stay in hospital

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026