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Clinical Trials/NCT06337877
NCT06337877
Completed
N/A

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

Tepecik Training and Research Hospital1 site in 1 country52 target enrollmentOctober 1, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Sedation Complication
Sponsor
Tepecik Training and Research Hospital
Enrollment
52
Locations
1
Primary Endpoint
To determine the sedation levels of patients during paralysis
Status
Completed
Last Updated
10 months ago

Overview

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."

Registry
clinicaltrials.gov
Start Date
October 1, 2023
End Date
April 24, 2024
Last Updated
10 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Tepecik Training and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

Aykut Saritas

associated professor

Tepecik Training and Research Hospital

Eligibility Criteria

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."

Outcomes

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),(The assessment process conducted immediately before the application of paralysis.")

Study Sites (1)

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