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Bispectral Index Monitoring To Guide Sedation In The Critical Care Setting

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02909010
Acronym
BIS65
Enrollment
150
Registered
2016-09-21
Start date
2015-05-31
Completion date
2018-09-30
Last updated
2016-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deep Sedation

Brief summary

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

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.

Interventions

DEVICEBIS™ Brain Monitoring System

The intervention group using BIS monitoring to adjust sedation in order to maintain values between 50-60

OTHERRASS

control group in which sedation was adjusted with the exclusive use of Richmond Agitation-Sedation Scale (RASS) to maintain RASS -2

Sponsors

Hospital Universitari de Bellvitge
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to 100 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Total Dose of sedationTwo yearsTotal dose of sedatives administered in the intervention group compared with the control group.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026