- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02394418
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Withdrawn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
|
Treatment of delirium by inhaled sevoflurane
Other Names:
|
Active Comparator: Propofol
Treatment of delirium by propofol i.v.
infusion
|
Treatment of delirium by propofol i.v.
infusion
Other Names:
|
Active Comparator: Dexmedetomidine
Treatment of delirium by dexmedetomidine i.v.
infusion
|
Treatment of delirium by dexmedetomidine i.v.
infusion
Other Names:
|
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.
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
- Mental Disorders
- Nervous System Diseases
- Neurologic Manifestations
- Confusion
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Delirium
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Analgesics, Non-Narcotic
- Platelet Aggregation Inhibitors
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Hypnotics and Sedatives
- Anesthetics, Inhalation
- Propofol
- Dexmedetomidine
- Sevoflurane
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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