Comparison of Dexmedetomidine and Propofol on the Delirium and Neuroinflammation in Patients With SIRS.

August 13, 2019 updated by: Valery V. Likhvantsev, Professor, Moscow Regional Research and Clinical Institute Moniki n.a. M.F. Vladimirskiy

Comparison of Sedative Effects of Dexmedetomidine and Propofol on the Clinical Course of Delirium and Neuroinflammation in Patients With SIRS.

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • presence of delirium

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: dexmedetomidine
Treatment of delirium by dexmedetomidine i.v. infusion
Drug: Dexmedetomidine
Treatment of delirium by dexmedetomidine i.v. infusion
Other Names:
  • Dexdor
Active Comparator: propofol
Treatment of delirium by propofol i.v. infusion
Drug: Propofol
Treatment of delirium by Propofol i.v. infusion
Other Names:
  • Diprivan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
CAM-ICU scale
Time Frame: up to 5 days
up to 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Moscow Regional Research and Clinical Institute Moniki n.a. M.F. Vladimirskiy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

January 26, 2015

First Submitted That Met QC Criteria

February 11, 2015

First Posted (Estimate)

February 19, 2015

Study Record Updates

Last Update Posted (Actual)

August 14, 2019

Last Update Submitted That Met QC Criteria

August 13, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D-P-SIRS-220115

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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