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Effects of Propofol and Sevoflurane on Early POCD in Elderly Patients With Metabolic Syndrome

Primary Purpose

Postoperative Complications

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
metabolic syndrome
Sponsored by
General Hospital of Ningxia Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Complications focused on measuring Postoperative cognitive dysfunction, metabolic syndrome, propofol, sevoflurane

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • aged ≥60 years;
  • ASAⅡor Ⅲ
  • noncardiac surgery and nonneural surgery

Exclusion Criteria:

  • Mini Mental State Examination [MMSE] score too low
  • chronic alcoho and drug abuse
  • disturbed renal and liver function
  • history of a cerebrovascular accident
  • permanent ventricular pacing
  • preoperative cognitive deficits
  • lack of cooperation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    propofol group

    sevoflurane group

    Arm Description

    Patients with metabolic syndrome were randomly assigned to receive propofol anesthesia

    Patients with metabolic syndrome were randomly assigned to receive sevoflurane anesthesia

    Outcomes

    Primary Outcome Measures

    Number of participants with Postoperative cognitive dysfunction (POCD) as assessed by Mini-Mental State Examination (MMSE) score in propofol group and sevoflurane group

    Secondary Outcome Measures

    Full Information

    First Posted
    May 1, 2016
    Last Updated
    June 29, 2016
    Sponsor
    General Hospital of Ningxia Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02766062
    Brief Title
    Effects of Propofol and Sevoflurane on Early POCD in Elderly Patients With Metabolic Syndrome
    Official Title
    Effects of Propofol and Sevoflurane on Early Postoperative Cognitive Dysfunction in Elderly Patients With Metabolic Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2015 (undefined)
    Primary Completion Date
    April 2016 (Actual)
    Study Completion Date
    May 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    General Hospital of Ningxia Medical University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to investigate propofol versus sevoflurane anesthesia on the effects of early postoperative cognitive function in elderly patients with metabolic syndrome.
    Detailed Description
    By now, a series risk factors of cardiovascular diseases, which are also related to the development of postoperative cognitive dysfunction (POCD), are becoming more common.The investigators don't know whether propofol based anesthesia has a more severe impact on early postoperative cognitive function than sevoflurane in elderly patients with metabolic syndrome. In this study, the investigators want to investigate propofol versus sevoflurane anesthesia on the effects of early postoperative cognitive function in elderly patients with metabolic syndrome.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Complications
    Keywords
    Postoperative cognitive dysfunction, metabolic syndrome, propofol, sevoflurane

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    94 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    propofol group
    Arm Type
    Active Comparator
    Arm Description
    Patients with metabolic syndrome were randomly assigned to receive propofol anesthesia
    Arm Title
    sevoflurane group
    Arm Type
    Active Comparator
    Arm Description
    Patients with metabolic syndrome were randomly assigned to receive sevoflurane anesthesia
    Intervention Type
    Other
    Intervention Name(s)
    metabolic syndrome
    Intervention Description
    metabolic syndrome
    Primary Outcome Measure Information:
    Title
    Number of participants with Postoperative cognitive dysfunction (POCD) as assessed by Mini-Mental State Examination (MMSE) score in propofol group and sevoflurane group
    Time Frame
    up to 7days postoperatively

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: aged ≥60 years; ASAⅡor Ⅲ noncardiac surgery and nonneural surgery Exclusion Criteria: Mini Mental State Examination [MMSE] score too low chronic alcoho and drug abuse disturbed renal and liver function history of a cerebrovascular accident permanent ventricular pacing preoperative cognitive deficits lack of cooperation

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    safety

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    Effects of Propofol and Sevoflurane on Early POCD in Elderly Patients With Metabolic Syndrome

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