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BIS-Guided Sedation in Critically Ill Patients Under Deep Sedation

NCT03840577 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2023-08-01

No results posted yet for this study

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.

Conditions

  • Delirium
  • Sedative Overdose

Interventions

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.

Sponsors & Collaborators

  • Hospital Italiano de Buenos Aires

    lead OTHER

Principal Investigators

  • Sergio Giannasi, MD · Hospital Italiano de Buenos Aires

  • Federico Carini, MD · Hospital Italiano de Buenos Aires

  • Ivan A. Huespe, MD · Hospital Italiano de Buenos Aires

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2022-04-22
Completion
2024-01-01
FDA Device
Yes

Countries

  • Argentina

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03840577 on ClinicalTrials.gov