NCT03840577

BIS-Guided Sedation in Critically Ill Patients Under Deep Sedation

Effect of Bispectral Index (BIS)-Guided Sedation on Delirium and Sedative Drug Requirements in Critically Ill Patients Under Deep Sedation

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: Hospital Italiano de Buenos Aires · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

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 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.

Conditions

• Delirium
• Sedative Overdose

Interventions

Type	Name	Description
DEVICE	Monitorization of sedation by Bispectral Index	The sedative dose administered through a continuous infusion pump will be adjusted based on the BIS value to maintain a target range of 40 to 60. If the BIS value is below the target range, the dose will be increased, and if it exceeds the range, the dose will be decreased, aiming to keep the BIS within the desired range.

Timeline

• Start date: 2019-04-01
• Primary completion: 2022-04-22
• Completion: 2024-01-01
• First posted: 2019-02-15
• Last updated: 2023-08-01

Locations

1 site across 1 country: Argentina

Regulatory

• FDA-regulated device study