NCT06337877

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 52 (actual)
• Sponsor: Tepecik Training and Research Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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."

Conditions

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

Interventions

Type	Name	Description
PROCEDURE	Depth 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.

Timeline

• Start date: 2023-10-01
• Primary completion: 2024-04-17
• Completion: 2024-04-24
• First posted: 2024-03-29
• Last updated: 2025-06-11

Locations

1 site across 1 country: Turkey (Türkiye)