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Effect of Sevoflurane, Propofol and Dexmedetomidine on Delirium & Neuroinflammation in Mechanically Ventilated Patients

Primary Purpose

Delirium

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Sevoflurane
Propofol
Dexmedetomidine
Sponsored by
Moscow Regional Research and Clinical Institute Moniki n.a. M.F. Vladimirskiy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Delirium

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • presence of delirium

Exclusion Criteria:

  • presence of Alzheimer's disease
  • any mental disorder
  • presence of cancer

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Sevoflurane

    Propofol

    Dexmedetomidine

    Arm Description

    Treatment of delirium by inhaled sevoflurane

    Treatment of delirium by propofol i.v. infusion

    Treatment of delirium by dexmedetomidine i.v. infusion

    Outcomes

    Primary Outcome Measures

    Duration of Delirium
    Delirium assessment by CAM-ICU scale

    Secondary Outcome Measures

    Change of protein S100b in serum
    Change of GSK-3beta in serum

    Full Information

    First Posted
    January 27, 2015
    Last Updated
    August 13, 2019
    Sponsor
    Moscow Regional Research and Clinical Institute Moniki n.a. M.F. Vladimirskiy
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02394418
    Brief Title
    Effect of Sevoflurane, Propofol and Dexmedetomidine on Delirium & Neuroinflammation in Mechanically Ventilated Patients
    Official Title
    Comparison of Sedative Effects of Sevoflurane, Propofol and Dexmedetomidine on the Clinical Course of Delirium and Neuroinflammation in Mechanically Ventilated Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2019
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    for technical reasons
    Study Start Date
    September 1, 2017 (Anticipated)
    Primary Completion Date
    May 2018 (Anticipated)
    Study Completion Date
    August 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Moscow Regional Research and Clinical Institute Moniki n.a. M.F. Vladimirskiy

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Assessment of sedative effects of sevoflurane, dexmedetomidine and propofol on the clinical course of delirium, SIRS and neuroinflammation in mechanically ventilated patients using CAM-ICU scale, GSK-3beta and protein S100b in serum.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Delirium

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Sevoflurane
    Arm Type
    Active Comparator
    Arm Description
    Treatment of delirium by inhaled sevoflurane
    Arm Title
    Propofol
    Arm Type
    Active Comparator
    Arm Description
    Treatment of delirium by propofol i.v. infusion
    Arm Title
    Dexmedetomidine
    Arm Type
    Active Comparator
    Arm Description
    Treatment of delirium by dexmedetomidine i.v. infusion
    Intervention Type
    Drug
    Intervention Name(s)
    Sevoflurane
    Other Intervention Name(s)
    Sevorane
    Intervention Description
    Treatment of delirium by inhaled sevoflurane
    Intervention Type
    Drug
    Intervention Name(s)
    Propofol
    Other Intervention Name(s)
    Diprivan
    Intervention Description
    Treatment of delirium by propofol i.v. infusion
    Intervention Type
    Drug
    Intervention Name(s)
    Dexmedetomidine
    Other Intervention Name(s)
    Dexdor
    Intervention Description
    Treatment of delirium by dexmedetomidine i.v. infusion
    Primary Outcome Measure Information:
    Title
    Duration of Delirium
    Description
    Delirium assessment by CAM-ICU scale
    Time Frame
    up to 5 days
    Secondary Outcome Measure Information:
    Title
    Change of protein S100b in serum
    Time Frame
    from delirium onset up to 5 days
    Title
    Change of GSK-3beta in serum
    Time Frame
    from delirium onset up to 5 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: presence of delirium Exclusion Criteria: presence of Alzheimer's disease any mental disorder presence of cancer
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Valery Likhvantsev, MD,PhD
    Organizational Affiliation
    Moscow Regional Research Clinical Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Effect of Sevoflurane, Propofol and Dexmedetomidine on Delirium & Neuroinflammation in Mechanically Ventilated Patients

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