Bispectral Index Monitoring To Guide Sedation In The Critical Care Setting

Study Overview
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Brief Summary
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A randomized, control trial to compare the total dose of sedatives use in patients over 65 years admitted to the intensive care unit, guiding sedation by monitoring with BIS® versus monitoring with the exclusive use of sedation scales. The study will include all patients over 65 years who enter the intensive care unit of the University Hospital of Bellvitge affected with medical or surgical pathology of non neurological etiology who require sedation for more than 24 hours to maintain adaptation to mechanical ventilation.

Detailed Description
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Patients admitted to the intensive care unit (ICU) usually require use of hypnotics and sedatives to ensure comfort and proper adaptation to mechanical ventilation. An important requirement for an adequate sedation is frequent and proper assessment of its depth. Inadequate sedation can lead to problems of over-sedation, under-sedation and/or delirium in ICU, especially in elderly patients. The main objective od the study is To compare the total dose of sedative use and the rate of over-sedation in patients over 65 years admitted to the ICU, adjusting sedation by monitoring with BIS® versus monitoring with the exclusive use of sedation scales. METHODS. A randomized, clinical trial including patients over 65 years who were admitted to the ICU affected with medical or surgical pathology of non neurological etiology who required sedation for more than 24 hours to maintain adaptation to mechanical ventilation. Patients were randomized into two groups: the intervention group using BIS monitoring to adjust sedation in order to maintain values between 50-60 and; the control group in which sedation was adjusted with the exclusive use of Richmond Agitation-Sedation Scale (RASS) to maintain RASS -2. The study was approved by the institution's Research Ethics Committee.

Official Title
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Bispectral Index Monitoring To Guide Sedation In Patients With Non-Neurological Pathology Over 65 Years, Admitted To Intensive Care Unit: Randomized Control Trial

Conditions
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Deep Sedation

Intervention / Treatment
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* Device: BIS™ Brain Monitoring System
* Other: RASS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients over 65 yers Patients admitted to teintensive care unit of the University Hospital of Bellvitge medical or surgical pathology of neurological etiology Patiens requiring sedation for more than 24 hours Exclusion Criteria: Patients less than 65 years Patients admitted to the ICU with Neurological condition. Postoperative patients admitted and extubation is expected within 24 hours.

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BIS™ Brain Monitoring System<br>BIS monitoring to adjust sedation in order to maintain values between 50-60 | Device: BIS™ Brain Monitoring System<br>* The intervention group using BIS monitoring to adjust sedation in order to maintain values between 50-60<br>|
| Placebo Comparator: RASS Monitorization<br>sedation was adjusted with the exclusive useof Richmond Agitation-Sedation Scale (RASS) to maintain RASS -2. | Other: RASS<br>* control group in which sedation was adjusted with the exclusive use of Richmond Agitation-Sedation Scale (RASS) to maintain RASS -2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Dose of sedation | Total dose of sedatives administered in the intervention group compared with the control group. | Two years |