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Comparison of Postoperative Outcome After Sevoflurane and Propofol Anaesthesia

Primary Purpose

Postoperative Cognitive Dysfunction

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
sevoflurane
propofol
Sponsored by
Xinqiao Hospital of Chongqing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Cognitive Dysfunction focused on measuring Sevoflurane, Propofol, Cardiac valvular surgery, Cardiopulmonary bypass, Postoperative cognitive dysfunction

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Xinan Hospital, Third Military Medical University
  • Xinqiao Hospital, Third Military Medical University
  • Daping Hospital, Third Military Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sevoflurane

Propofol

Arm Description

Maintenance of anesthesia with sevoflurane during the cardiac valvular surgery.

Maintenance of anesthesia propofol during the cardiac valvular surgery.

Outcomes

Primary Outcome Measures

Number of patients with postoperative cognitive dysfunction (POCD)
POCD is a composite outcome measure

Secondary Outcome Measures

Postoperative delirium (POD)
POD is evaluated by a commonly used questionnaire

Full Information

First Posted
October 10, 2016
Last Updated
July 9, 2018
Sponsor
Xinqiao Hospital of Chongqing
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1. Study Identification

Unique Protocol Identification Number
NCT02931877
Brief Title
Comparison of Postoperative Outcome After Sevoflurane and Propofol Anaesthesia
Official Title
Comparison of Postoperative Outcome and Cognitive Function After Sevoflurane and Propofol Anaesthesia for Cardiac Valvular Surgery With Cardiopulmonary Bypass
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xinqiao Hospital of Chongqing

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Cognitive Dysfunction
Keywords
Sevoflurane, Propofol, Cardiac valvular surgery, Cardiopulmonary bypass, Postoperative cognitive dysfunction

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sevoflurane
Arm Type
Experimental
Arm Description
Maintenance of anesthesia with sevoflurane during the cardiac valvular surgery.
Arm Title
Propofol
Arm Type
Active Comparator
Arm Description
Maintenance of anesthesia propofol during the cardiac valvular surgery.
Intervention Type
Drug
Intervention Name(s)
sevoflurane
Intervention Type
Drug
Intervention Name(s)
propofol
Primary Outcome Measure Information:
Title
Number of patients with postoperative cognitive dysfunction (POCD)
Description
POCD is a composite outcome measure
Time Frame
From 7 days after the surgery to the day of discharge from hospital
Secondary Outcome Measure Information:
Title
Postoperative delirium (POD)
Description
POD is evaluated by a commonly used questionnaire
Time Frame
Up to 7 days after the surgery
Other Pre-specified Outcome Measures:
Title
Degree of increase of stress hormones
Description
Stress hormones include S-100β, Il-6, etc.
Time Frame
Up to 24 hours after the surgery
Title
Length of ICU stay
Description
The time for patient stay in ICU
Time Frame
Up to 7 days after the surgery
Title
Length of hospital stay
Description
The time for patient stay in hospital
Time Frame
Up to 3 months after the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 ≤ 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hong Li, M.D.
Organizational Affiliation
Department of Anesthesiology, Xinqiao Hospital, Third Military Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xinan Hospital, Third Military Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400037
Country
China
Facility Name
Xinqiao Hospital, Third Military Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400037
Country
China
Facility Name
Daping Hospital, Third Military Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Comparison of Postoperative Outcome After Sevoflurane and Propofol Anaesthesia

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