Status:
UNKNOWN
BIS-Guided Sedation in Critically Ill Patients Under Deep Sedation
Lead Sponsor:
Hospital Italiano de Buenos Aires
Conditions:
Delirium
Sedative Overdose
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this clinical trial is to investigate the effectiveness of sedation guided by the bispectral index (BIS) in reducing the incidence of delirium and the doses of sedative drugs used in criti...
Detailed Description
A Phase 4, randomized (1:1), controlled, double-blind, unicenter clinical trial aims to assess the effectiveness of sedation guided by the Bispectral Index (BIS) compared to sedation guided by clinica...
Eligibility Criteria
Inclusion
- Patients older than 18 years.
- Under mechanical ventilation in the intensive care unit
- Indication of deep sedation (RASS objective -4, -5)
- Admission to the ICU or indication of deep sedation up to 8 hours prior to randomization.
Exclusion
- Patients with end-of-life care.
- Family refusal to participate in the study.
- Impossibility to place the BIS sensor (burns, extensive lesions on the forehead, prone position, etc.).
- Patients with intracranial hypertension or convulsive status, in whom sedation has the objective of suppressing electroencephalographic waves.
- Patients who, following a decrease in sedation, have a coma, vegetative state or a state of minimal consciousness.
Key Trial Info
Start Date :
April 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2024
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT03840577
Start Date
April 1 2019
End Date
January 1 2024
Last Update
August 1 2023
Active Locations (1)
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1
Hospital Italiano de Buenos Aires
Capital Federal, Argentina, 1173