Overview

This trial is active, not recruiting.

Condition deep sedation
Treatments bis™ brain monitoring system, rass
Sponsor Hospital Universitari de Bellvitge
Start date May 2015
End date June 2018
Trial size 150 participants
Trial identifier NCT02909010, AC063/15

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Active Comparator)
BIS monitoring to adjust sedation in order to maintain values between 50-60
bis™ brain monitoring system
The intervention group using BIS monitoring to adjust sedation in order to maintain values between 50-60
(Placebo Comparator)
sedation was adjusted with the exclusive useof Richmond Agitation-Sedation Scale (RASS) to maintain RASS -2.
rass
control group in which sedation was adjusted with the exclusive use of Richmond Agitation-Sedation Scale (RASS) to maintain RASS -2

Primary Outcomes

Measure
Total Dose of sedation
time frame: Two years

Eligibility Criteria

Male or female participants from 65 years up to 100 years old.

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.

Additional Information

Official title Bispectral Index Monitoring To Guide Sedation In Patients With Non-Neurological Pathology Over 65 Years, Admitted To Intensive Care Unit: Randomized Control Trial
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Hospital Universitari de Bellvitge.