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Assessment of Sedation Depth Using Processed EEG in ICU Patients With ARDS Receiving Neuromuscular Blockade: A Prospective Observational Study

Assessment of Sedation Depth Using Processed EEG in ICU Patients With ARDS Receiving Neuromuscular Blockade: A Prospective Observational Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06337877
Enrollment
52
Registered
2024-03-29
Start date
2023-10-01
Completion date
2024-04-24
Last updated
2025-06-11

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

Conditions

Acute Respiratory Distress Syndrome Due to COVID-19, Anesthesia Awareness, Sedation Complication

Brief summary

In intensive care units, therapeutic paralysis has been a routine treatment method for many years in a select group of patients. Sufficient and appropriate sedation in patients undergoing therapeutic paralysis is crucial to prevent awareness and reduce the risk of excessive sedation. Both inadequate and excessive sedation levels can be highly detrimental to the patient. Clinical assessment may not always provide accurate information regarding sedation depth. Recently, the frequency and workload of therapeutic paralysis treatment in intensive care units have increased due to COVID-19 pneumonia. Therefore, the investigators believe that inadequate sedation may be common in these patients. Processed electroencephalogram parameters such as bispectral index or patient state index (PSI), routinely used in operating rooms and intensive care units, are commonly used to indicate sedation depth. In this study, the investigators aimed to determine sedation levels in patients during paralysis, assess the prevalence of inadequate or excessive sedation, and observe the doses of sedatives and analgesics used.

Interventions

PROCEDUREDepth of sedation monitoring

In the study, group rates of patient state index (PSI) \[(below 25); (25-50); (51-75); (above 75)\] will be determined within a 24-hour timeframe in patients undergoing therapeutic paralysis. The concordance between PSI rates\* determined at baseline (time zero) and Richmond Agitation-Sedation Scale (RASS) \[(between -4 and -5); (between -3 and -2); (equal to or greater than -1)\] rates will be assessed. Suppression rate (SR) and electromyography (EMG) values will be obtained from patients, and significant differences among PSI groups \[(below 25); (25-50); (51-75); (above 75)\] in terms of these data will be examined. Additionally, changes in Propofol (mg/hour), Midazolam (mg/hour), Fentanyl (mg/hour), and Rocuronium (mg/hour) values will be analyzed for each time interval.

Sponsors

Tepecik Training and Research Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* Patients aged 18 years and older who have received continuous neuromuscular blocking agents for at least 24 hours.

Exclusion criteria

1. Patients under 18 years of age, 2. pregnant individuals 3. trauma patients, 4. intracerebral pathology 5. major bleeding 6. central nervous system diseases, 7. pre-existing poor neurological condition before admission to the intensive care unit, 8. inability to document continuous neuromuscular blocking agent infusion for at least 24 hours.

Design outcomes

Primary

MeasureTime frameDescription
To determine the sedation levels of patients during paralysisFor patients undergoing therapeutic paralysis, over a 24-hour period,In the study, for patients undergoing therapeutic paralysis, routinely applied non-invasive patient state index (0-100) values will be recorded. These recorded values will be blindedly recorded from the clinician, who will not be alerted or intervene based on the values.
The prevalence of inadequate or excessive sedation,For patients undergoing therapeutic paralysis, over a 24-hour period,In the study, for patients undergoing therapeutic paralysis, routinely applied non-invasive patient state index (0-100) values will be recorded. These recorded values will be blindedly recorded from the clinician, who will not be alerted or intervene based on the values.

Secondary

MeasureTime frameDescription
Evaluation of Concordance Between Richmond Agitation-Sedation Scale (RASS),The assessment process conducted immediately before the application of paralysis.Evaluation of Concordance Between Richmond Agitation-Sedation Scale \[(+4)- (-5)\], a scale used in clinical assessment.

Countries

Turkey (Türkiye)

Outcome results

None listed

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