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

NCT ID: NCT06337877

Last Updated: 2025-06-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 52 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2024-04-24

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."

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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."

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tepecik Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Aykut Saritas

associated professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Aykut Saritaş

Izmir, İzmir, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

pEEG ARDS

Identifier Type: -

Identifier Source: org_study_id