BIS-Guided Sedation in Critically Ill Patients Under Deep Sedation

Hospital Italiano de Buenos Aires

Status

Active, not recruiting

Conditions

Delirium

Sedative Overdose

Treatments

Device: Monitorization of sedation by Bispectral Index

Study type

Interventional

Funder types

Other

Identifiers

NCT03840577

3880

Details and patient eligibility

About

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 critical patients who require deep sedation. The main questions this study aims to answer are:

Does sedation guided by BIS lead to higher delirium and coma-free days compared to clinical monitoring?
Does sedation guided by BIS result in reduced doses of sedative drugs compared to clinical monitoring?

Participants in this study will be randomly assigned to one of two groups:

Clinical Monitoring Group: Participants in this group will receive sedation based on clinical scales. These participants will also be fitted with a BIS sensor, but the sensor will be covered.

Sedation Guided by BIS Group: Participants in this group will receive sedation guided by the bispectral index.

The study will be conducted as a prospective, controlled, blind intervention trial with random distribution and intention to treat. The primary outcomes to be evaluated include:

Delirium and coma-free days after the end of deep sedation using the Confusion Assessment Method for the ICU (CAM-ICU) scale.
Total dose of sedative drugs administered.
BIS values

Researchers will compare the two groups to determine if sedation guided by BIS is associated with a higher number of delirium and coma-free days, reduced sedative drug doses, and higher values of BIS compared to clinical monitoring.

Full 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 clinical scales in critically ill patients under deep sedation. The primary objective is to investigate whether BIS-guided sedation can reduce the incidence of delirium and decrease the doses of sedative drugs administered.

Enrollment

99 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.