NCT02394418WithdrawnPhase 4
Comparison of Sedative Effects of Sevoflurane, Propofol and Dexmedetomidine on the Clinical Course of Delirium and Neuroinflammation in Mechanically Ventilated Patients
Moscow Regional Research and Clinical Institute (MONIKI)0 sitesStarted: September 1, 2017Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Withdrawn
- Sponsor
- Primary Endpoint
- Duration of Delirium
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •presence of delirium
Exclusion Criteria
- •presence of Alzheimer's disease
- •any mental disorder
- •presence of cancer
Arms & Interventions
Sevoflurane
Active Comparator
Treatment of delirium by inhaled sevoflurane
Intervention: Sevoflurane (Drug)
Propofol
Active Comparator
Treatment of delirium by propofol i.v. infusion
Intervention: Propofol (Drug)
Dexmedetomidine
Active Comparator
Treatment of delirium by dexmedetomidine i.v. infusion
Intervention: Dexmedetomidine (Drug)
Outcomes
Primary Outcomes
Duration of Delirium
Time Frame: up to 5 days
Delirium assessment by CAM-ICU scale
Secondary Outcomes
- Change of protein S100b in serum(from delirium onset up to 5 days)
- Change of GSK-3beta in serum(from delirium onset up to 5 days)
Investigators
Valery V. Likhvantsev, Professor
senior researcher
Moscow Regional Research and Clinical Institute (MONIKI)
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