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WithdrawnNCT02394418Updated Aug 15, 2019

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

A Phase 4 interventional study of Sevoflurane and Propofol in Delirium, sponsored by Moscow Regional Research and Clinical Institute (MONIKI). Withdrawn. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-08-15.

Sponsored by Moscow Regional Research and Clinical Institute (MONIKI) · Phase 4, Interventional, and Treatment

Why this study was withdrawn
for technical reasons
Phase
Phase 4
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

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Conditions studied

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In context

Delirium

1,057 studies on the registry are indexed under Delirium; 238 are open to participants now.

Browse Delirium studies →

Lead sponsor

Moscow Regional Research and Clinical Institute (MONIKI) is the lead sponsor of 14 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • presence of delirium

Exclusion criteria

Exclusion Criteria:

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

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
0 participants (actual)

Study arms

  • Active comparator
    Sevoflurane

    Treatment of delirium by inhaled sevoflurane

    Drug: Sevoflurane

  • Active comparator
    Propofol

    Treatment of delirium by propofol i.v. infusion

    Drug: Propofol

  • Active comparator
    Dexmedetomidine

    Treatment of delirium by dexmedetomidine i.v. infusion

    Drug: Dexmedetomidine

Interventions

  • DrugSevoflurane

    Treatment of delirium by inhaled sevoflurane

    Also known as: Sevorane

  • DrugPropofol

    Treatment of delirium by propofol i.v. infusion

    Also known as: Diprivan

  • DrugDexmedetomidine

    Treatment of delirium by dexmedetomidine i.v. infusion

    Also known as: Dexdor

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What researchers measure

Primary outcomes

  1. Duration of Delirium

    Delirium assessment by CAM-ICU scale

    Time frame: up to 5 days

Secondary outcomes

  1. Change of protein S100b in serum

    Time frame: from delirium onset up to 5 days

  2. Change of GSK-3beta in serum

    Time frame: from delirium onset up to 5 days

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02394418
Lead sponsor
Moscow Regional Research and Clinical Institute (MONIKI)
Responsible party
Valery V. Likhvantsev, Professor (senior researcher, Moscow Regional Research and Clinical Institute (MONIKI)) — Principal investigator
First posted
Mar 20, 2015
Start date
Sep 1, 2017 (estimated)
Primary completion
May 2018 (estimated)
Completion
Aug 2018 (estimated)
Last update
Aug 15, 2019

Study contacts

Valery Likhvantsev, MD,PhD
principal investigator · Moscow Regional Research Clinical Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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