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Role of Propofol Postconditioning on Oxidative Stress and Cognitive Function

Primary Purpose

Cerebral Arterial Aneurysm

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
propofol postconditioning
sevoflurane
Sponsored by
The Third Central Clinical College of Tianjin Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cerebral Arterial Aneurysm

Eligibility Criteria

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

Inclusion Criteria:

  • Clinical diagnosis intracranial aneurysm surgery ,
  • American Society of Anesthesiologists (ASA)Ⅰ-Ⅱ.

Exclusion Criteria:

  • severe hepatic and renal dysfunction
  • coagulation disorder
  • taking antioxidant perioperative period

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    propofol postconditioning

    sevoflurane

    Arm Description

    1.2mg/L propofol

    0.5%-2% sevoflurane

    Outcomes

    Primary Outcome Measures

    Evidences of Clinically Definite Oxidative Stress Confirmed by ELISA Kit
    Evidences of clinically definite oxidative stress :Superoxide dismutase activity, Hydroxyl radical
    Evidences of Clinically Definite Oxidative Stress Confirmed by ELISA
    Evidences of clinically definite oxidative stress:8-isoprostane,as a reliable biomarkers of lipid peroxidation
    Evidences of Clinically Definite Oxidative Stress:Micronuclei
    Evidences of clinically definite oxidative stress:micronuclei confirmed by Cytokinesis-block Micronucleus Test
    Evidences of Clinically Definite Oxidative Stress Confirmed by High Performance Liquid Chromatography
    Evidences of clinically definite oxidative stress :α- tocopherol,γ- tocopherol which was used to assess the antioxidant defense.
    Evidences of Clinically Definite Oxidative Stress: Nuclear Buds
    Evidences of clinically definite oxidative stress:nuclear buds Confirmed by Cytokinesis-block Micronucleus Test
    Evidences of Clinically Definite Oxidative Stress: Nucleoplasmic Bridges
    Evidences of clinically definite oxidative stress: nucleoplasmic bridges confirmed by Cytokinesis-block Micronucleus Test

    Secondary Outcome Measures

    Mini Mental State Examination (MMSE)
    A questionnaires is used to assess the cognitive function of patients in clinical,the total range was 0-30,and 27-30 were considered as normal value,<27 were considered as recognitive dysfunction.
    Montreal Cognitive Assessment (MoCA)
    A questionnaires is used to assess the cognitive function of patients in clinical,the total range was 0-30,and 27-30 were considered as normal value,<27 were considered as recognitive dysfunction.

    Full Information

    First Posted
    February 3, 2016
    Last Updated
    June 10, 2017
    Sponsor
    The Third Central Clinical College of Tianjin Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02691416
    Brief Title
    Role of Propofol Postconditioning on Oxidative Stress and Cognitive Function
    Official Title
    Role of Propofol Postconditioning on Oxidative Stress and Cognitive Function in Patients Undergoing Intracranial Aneurysm Surgery.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2014 (undefined)
    Primary Completion Date
    December 2015 (Actual)
    Study Completion Date
    January 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The Third Central Clinical College of Tianjin Medical University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study was to evaluate differences between propofol postconditioning and sevoflurane anesthesia in the intracranial aneurysm surgery about antioxidant effect.
    Detailed Description
    intracranial aneurysm surgery may lead to regional ischemic reperfusion injury. Propofol, as an antioxidative phenol, has been demonstrated that mitigate the brain I/R in rats. As for sevoflurane, some investigation indicated that sevoflurane is able to reduce oxidative stress in cell(except neuronal cell lines ) and rodent models, but the antioxidant effect did not found in human minor incision surgeries, furthermore, oxidative stress was raised in the major surgeries including orthopedic surgeries, hysterectomy, cholecystectomy, and thoracotomy

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cerebral Arterial Aneurysm

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    propofol postconditioning
    Arm Type
    Experimental
    Arm Description
    1.2mg/L propofol
    Arm Title
    sevoflurane
    Arm Type
    Experimental
    Arm Description
    0.5%-2% sevoflurane
    Intervention Type
    Drug
    Intervention Name(s)
    propofol postconditioning
    Intervention Description
    administrated Target Controlled Infusion(TCI) of propofol (Cp 1.2ug/ml) and decreased sevoflurane with a Bispectral index (BIS) value of 40-60 to maintain anesthesia after clamp removal
    Intervention Type
    Drug
    Intervention Name(s)
    sevoflurane
    Intervention Description
    0.5%-2% sevoflurane with BIS 40-60
    Primary Outcome Measure Information:
    Title
    Evidences of Clinically Definite Oxidative Stress Confirmed by ELISA Kit
    Description
    Evidences of clinically definite oxidative stress :Superoxide dismutase activity, Hydroxyl radical
    Time Frame
    before induction,after clamping removal ,operation ending ,1,3,7days post surgery
    Title
    Evidences of Clinically Definite Oxidative Stress Confirmed by ELISA
    Description
    Evidences of clinically definite oxidative stress:8-isoprostane,as a reliable biomarkers of lipid peroxidation
    Time Frame
    before induction, after clamping removal,operation ending,1,3,7days post surgery
    Title
    Evidences of Clinically Definite Oxidative Stress:Micronuclei
    Description
    Evidences of clinically definite oxidative stress:micronuclei confirmed by Cytokinesis-block Micronucleus Test
    Time Frame
    before induction,clamping removal ,operation ending,1,3,7days post surgery
    Title
    Evidences of Clinically Definite Oxidative Stress Confirmed by High Performance Liquid Chromatography
    Description
    Evidences of clinically definite oxidative stress :α- tocopherol,γ- tocopherol which was used to assess the antioxidant defense.
    Time Frame
    before induction,after clamping removal ,operation ending ,1,3,7days post surgery
    Title
    Evidences of Clinically Definite Oxidative Stress: Nuclear Buds
    Description
    Evidences of clinically definite oxidative stress:nuclear buds Confirmed by Cytokinesis-block Micronucleus Test
    Time Frame
    before induction,clamping removal ,operation ending,1,3,7days post surgery
    Title
    Evidences of Clinically Definite Oxidative Stress: Nucleoplasmic Bridges
    Description
    Evidences of clinically definite oxidative stress: nucleoplasmic bridges confirmed by Cytokinesis-block Micronucleus Test
    Time Frame
    before induction,clamping removal ,operation ending,1,3,7days post surgery
    Secondary Outcome Measure Information:
    Title
    Mini Mental State Examination (MMSE)
    Description
    A questionnaires is used to assess the cognitive function of patients in clinical,the total range was 0-30,and 27-30 were considered as normal value,<27 were considered as recognitive dysfunction.
    Time Frame
    before induction,1,3,7days post surgery
    Title
    Montreal Cognitive Assessment (MoCA)
    Description
    A questionnaires is used to assess the cognitive function of patients in clinical,the total range was 0-30,and 27-30 were considered as normal value,<27 were considered as recognitive dysfunction.
    Time Frame
    before induction,1,3,7days post surgery

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Clinical diagnosis intracranial aneurysm surgery , American Society of Anesthesiologists (ASA)Ⅰ-Ⅱ. Exclusion Criteria: severe hepatic and renal dysfunction coagulation disorder taking antioxidant perioperative period
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Haiyun Wang
    Organizational Affiliation
    The Third Central Clinical College of Tianjin Medical University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Role of Propofol Postconditioning on Oxidative Stress and Cognitive Function

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