Back to resultsComparison of Dexmedetomidine and Propofol on the Delirium and Neuroinflammation in Patients With SIRS.
Primary Purpose
Delirium
Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Dexmedetomidine
Propofol
Sponsored by
About this trial
This is an interventional treatment trial for Delirium
Eligibility Criteria
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 Type
Active Comparator
Active Comparator
Arm Label
dexmedetomidine
propofol
Arm Description
Treatment of delirium by dexmedetomidine i.v. infusion
Treatment of delirium by propofol i.v. infusion
Outcomes
Primary Outcome Measures
CAM-ICU scale
Secondary Outcome Measures
Full Information
NCT ID
NCT02366299
First Posted
January 26, 2015
Last Updated
August 13, 2019
Sponsor
Moscow Regional Research and Clinical Institute Moniki n.a. M.F. Vladimirskiy
1. Study Identification
Unique Protocol Identification Number
NCT02366299
Brief Title
Comparison of Dexmedetomidine and Propofol on the Delirium and Neuroinflammation in Patients With SIRS.
Official Title
Comparison of Sedative Effects of Dexmedetomidine and Propofol on the Clinical Course of Delirium and Neuroinflammation in Patients With SIRS.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Withdrawn
Study Start Date
February 2015 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Actual)
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
Assessment of sedative effects of dexmedetomidine and propofol on the clinical course of delirium and neuroinflammation in patients with SIRS using CAM-ICU scale 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
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
dexmedetomidine
Arm Type
Active Comparator
Arm Description
Treatment of delirium by dexmedetomidine i.v. infusion
Arm Title
propofol
Arm Type
Active Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
Diprivan
Intervention Description
Treatment of delirium by Propofol i.v. infusion
Primary Outcome Measure Information:
Title
CAM-ICU scale
Time Frame
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
12. IPD Sharing Statement
Learn more about this trial
Comparison of Dexmedetomidine and Propofol on the Delirium and Neuroinflammation in Patients With SIRS.
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