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

"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."

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sedation Complication Acute Respiratory Distress Syndrome Due to COVID-19 Anesthesia Awareness Intraoperative Awareness Intraoperative Complications Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aykut Saritaş

Izmir, İzmir, 35640, Turkey (Türkiye)

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Depth of sedation monitoring

Procedure

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.

Primary outcomes

To determine the sedation levels of patients during paralysis

Time frame: 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."
The prevalence of inadequate or excessive sedation,

Time frame: 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 outcomes

Evaluation of Concordance Between Richmond Agitation-Sedation Scale (RASS),

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Tepecik Training and Research Hospital

Other

Registry information

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Mar 29, 2024
Registry last updated: Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed