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

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 Sevoflurane, Propofol and Dexmedetomidine on the Clinical Course of Delirium and Neuroinflammation in Mechanically Ventilated Patients

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.

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Withdrawn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: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Delirium
Time Frame: up to 5 days
Delirium assessment by CAM-ICU scale
up to 5 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Change of protein S100b in serum
Time Frame: from delirium onset up to 5 days
from delirium onset up to 5 days
Change of GSK-3beta in serum
Time Frame: from delirium onset up to 5 days
from delirium onset 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

Investigators

  • Principal Investigator: Valery Likhvantsev, MD,PhD, Moscow Regional Research Clinical Institute

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 (Anticipated)

September 1, 2017

Primary Completion (Anticipated)

May 1, 2018

Study Completion (Anticipated)

August 1, 2018

Study Registration Dates

First Submitted

January 27, 2015

First Submitted That Met QC Criteria

March 16, 2015

First Posted (Estimate)

March 20, 2015

Study Record Updates

Last Update Posted (Actual)

August 15, 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

  • S-D-P-MV-220115

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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