Bispectral Index Monitoring To Guide Sedation In The Critical Care Setting

Deep Sedation Clinical Trial

— BIS65  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02909010
• Other study ID #: AC063/15
• Status: Active, not recruiting
• Phase: N/A
• First received: September 19, 2016
• Last updated: September 19, 2016
• Start date: May 2015
• Est. completion date: September 2018

Study information

• Verified date: September 2016
• Source: Hospital Universitari de Bellvitge
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: September 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years to 100 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Deep Sedation

Intervention

Device:
• BIS™ Brain Monitoring System
The intervention group using BIS monitoring to adjust sedation in order to maintain values between 50-60

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari de Bellvitge

References & Publications (3)

Carrasco G. Instruments for monitoring intensive care unit sedation. Crit Care. 2000;4(4):217-25. Epub 2000 Jul 13. Review. — View Citation

De Deyne C, Struys M, Decruyenaere J, Creupelandt J, Hoste E, Colardyn F. Use of continuous bispectral EEG monitoring to assess depth of sedation in ICU patients. Intensive Care Med. 1998 Dec;24(12):1294-8. — View Citation

Fraser GL, Riker RR. Sedation and analgesia in the critically ill adult. Curr Opin Anaesthesiol. 2007 Apr;20(2):119-23. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Dose of sedation	Total dose of sedatives administered in the intervention group compared with the control group.	Two years	No