An interventional study of BIS™ Brain Monitoring System and RASS in Deep Sedation, sponsored by Hospital Universitari de Bellvitge. Status unknown. Open to participants aged 65 Years to 100 Years. Per ClinicalTrials.gov, last updated 2016-09-21.
Sponsored by Hospital Universitari de Bellvitge · Not applicable, Interventional, and Prevention
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.
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.
Hospital Universitari de Bellvitge is the lead sponsor of 118 studies on the registry; 29 are open to participants now.
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Exclusion Criteria:
BIS monitoring to adjust sedation in order to maintain values between 50-60
Device: BIS™ Brain Monitoring System
sedation was adjusted with the exclusive useof Richmond Agitation-Sedation Scale (RASS) to maintain RASS -2.
Other: RASS
The intervention group using BIS monitoring to adjust sedation in order to maintain values between 50-60
control group in which sedation was adjusted with the exclusive use of Richmond Agitation-Sedation Scale (RASS) to maintain RASS -2
Total Dose of sedation
Total dose of sedatives administered in the intervention group compared with the control group.
Time frame: Two years
No study locations are listed for this record.
Plan to share: Undecided
This study is status unknown, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Hospital Universitari de Bellvitge