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Prospective Electroencephalography Evaluation of Sedation in COVID-19

Prospective Evaluation of Aggravated Sedation in COVID-19 ARDS Patients Using Electroencephalography

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04815109
Enrollment
50
Registered
2021-03-24
Start date
2021-04-01
Completion date
2022-06-30
Last updated
2022-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Distress Syndrome, Conscious Sedation, Corona Virus Infection, Electroencephalogram, Pathologic Processes

Brief summary

Sedation of severe COVID-19 disease are often complicated. We try to find a correlate for this observation by encephalographic studies.

Detailed description

Sedation of critically ill ventilated coronavirus patients, continues to be a challenging issue. Also, neurological symptoms of severe COVID-19 disease have been described frequently. Difficulties in sedation of these patients have been discussed repeatedly. The aim of this study is to investigate whether an encephalographic correlate can be found. Appropriate processed encephalographic techniques have been used for anesthesia monitoring for many years. The aim of our study is to collect unrelated processed and raw EEG data of sedated COVID-19 patients and to investigate the correlation to the necessary sedation.

Interventions

OTHEREncephalography measurement

Encephalography measurement and partially aggravated sedation.

Sponsors

Goethe University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

Intubated ventilated patients with SARS-CoV-2 associated acute respiratory distress syndrome and sedation difficulty.

Exclusion criteria

Pre-existing severe cerebral brain damage and dysfunction. For example: previous medial infarction, cerebral hemorrhage, structural epilepsy.

Design outcomes

Primary

MeasureTime frameDescription
Raw data encephalography measurementFrom the beginning of the measurement until the end of the examination (10 to 20 minutes).Measurement of the brain activity detectable for the examination procedure in the surface encephalogram.
Processed encephalography measurementFrom the beginning of the measurement until the end of the examination (10 to 20 minutes).Measurement of detectable algorithm based patient sedation score based on brain activity in the surface encephalogram.

Secondary

MeasureTime frameDescription
Dosage of continuously administered centrally acting alpha2 agonists.From 90 minutes before to 10 minutes after encephalographic measurementSedative dosage continuously administered during the measurement interval. \[µg/kg/h\]
Dosage of continuously delivered central GABA receptor active substances.From 90 minutes before to 10 minutes after encephalographic measurementSedative dosage continuously administered during the measurement interval. \[mg/kg/h\]
Dosage of continuously delivered central NMDA receptor active substances.From 90 minutes before to 10 minutes after encephalographic measurementSedative dosage continuously administered during the measurement interval. \[mg/kg/h\]
Dosage of continuously delivered opioid based analgesia.From 90 minutes before to 10 minutes after encephalographic measurementAnalgetic dosage continuously administered during the measurement interval. \[µg/kg/h\]

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026