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Clinical Trials/NCT02366299
NCT02366299WithdrawnPhase 4

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

Moscow Regional Research and Clinical Institute (MONIKI)0 sitesStarted: February 2015Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Withdrawn
Sponsor
Primary Endpoint
CAM-ICU scale

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

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

dexmedetomidine

Active Comparator

Treatment of delirium by dexmedetomidine i.v. infusion

Intervention: Dexmedetomidine (Drug)

propofol

Active Comparator

Treatment of delirium by propofol i.v. infusion

Intervention: Propofol (Drug)

Outcomes

Primary Outcomes

CAM-ICU scale

Time Frame: up to 5 days

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Moscow Regional Research and Clinical Institute (MONIKI)
Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Valery V. Likhvantsev, Professor

senior researcher

Moscow Regional Research and Clinical Institute (MONIKI)

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