BIS-Guided Sedation in Critically Ill Patients Under Deep Sedation

July 28, 2023 updated by: Ivan A Huespe, MD, Hospital Italiano de Buenos Aires

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

99

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Argentina
      • Capital Federal, Argentina, 1173
        • Hospital Italiano de Buenos Aires

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Sedation guided by Clinical Scales
Sedative guided by RASS (Richmond Agitation-Sedation Scale) score. Target RASS: -4 / -5.
Experimental: Sedation guided by Bispectral Index
Sedation guided by the Bispectral Index (BIS). Target BIS between 40 to 60.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare delirium and coma free days until 14 days after end of deep sedation
Time Frame: Up to 14 days post end of deep sedation
To compare the number of Delirium and Coma-Free Days until day 14 after the cessation of deep sedation in patients receiving sedation guided by the Bispectral Index (BIS) vs. sedation guided by clinical scales. Delirium will be assessed using the CAM-ICU scale (Ely EW et al.) by non-ICU researchers who are blinded to the randomization allocation. The delirium evaluation will begin when the patient reaches a Richmond Agitation-Sedation Scale (RASS) score of > -3.
Up to 14 days post end of deep sedation
Compare the doses of sedative drugs received
Time Frame: From date of randomization until the date of end of deep sedation or date of death from any cause, whichever came first, assessed up to 90 days
To compare the total doses of Propofol, Midazolam, and Remifentanil (calculated in mg/kg) received during the period of deep sedation
From date of randomization until the date of end of deep sedation or date of death from any cause, whichever came first, assessed up to 90 days
Compare values of BIS
Time Frame: From date of randomization until the date of end of deep sedation or date of death from any cause, whichever came first, assessed up to 90 days
To compare the values of Bispectral Index (BIS) in patients receiving sedation guided by the Bispectral Index (BIS) versus sedation guided by clinical scales. This outcome will assess the BIS values recorded during the period of deep sedation and compare them between the two groups
From date of randomization until the date of end of deep sedation or date of death from any cause, whichever came first, assessed up to 90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time with values of BIS less than 40
Time Frame: From date of randomization until the date of end of deep sedation or date of death from any cause, whichever came first, assessed up to 90 days
To compare the number of hours that patients receiving sedation guided by the Bispectral Index (BIS) vs. sedation guided by clinical scales had registered Bispectral Index (BIS) values below 40 during the period of deep sedation. The duration of time with BIS values below 40 will be recorded for each patient.
From date of randomization until the date of end of deep sedation or date of death from any cause, whichever came first, assessed up to 90 days
Compare days alive and free of the ICU
Time Frame: From date of randomization until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 120 days
To compare the effect of sedation guided by the Bispectral Index (BIS) vs. sedation guided by clinical scales on days alive and free of the ICU
From date of randomization until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 120 days
Compare days alive and free of the hospital
Time Frame: From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 120 days
To compare the effect of sedation guided by the Bispectral Index (BIS) vs. sedation guided by clinical scales on days alive and free of the hospital
From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 120 days
Compare days alive and free of mechanical ventilation through Study Day 30
Time Frame: From date of randomization until the date of end of mechanical ventilation or date of death from any cause, whichever came first, assessed up to 30 days
To compare the effect of sedation guided by the Bispectral Index (BIS) vs. sedation guided by clinical scales on the number of days alive and free of mechanical ventilation through Study Day 30
From date of randomization until the date of end of mechanical ventilation or date of death from any cause, whichever came first, assessed up to 30 days
Compare days alive and free of mechanical ventilation through Study Day 60
Time Frame: From date of randomization until the date of end of mechanical ventilation or date of death from any cause, whichever came first, assessed up to 60 days
To compare the effect of sedation guided by the Bispectral Index (BIS) vs. sedation guided by clinical scales on the number of days alive and free of mechanical ventilation through Study Day 60
From date of randomization until the date of end of mechanical ventilation or date of death from any cause, whichever came first, assessed up to 60 days
Compare delirium and coma free days until 14 days after end of deep sedation in patients who had more than 24 hours of deep sedation
Time Frame: Up to 14 days post end of deep sedation
To compare the number of Delirium and Coma-Free Days until day 14 after the cessation of deep sedation in patients receiving sedation guided by the Bispectral Index (BIS) vs. sedation guided by clinical scales. Delirium will be assessed using the CAM-ICU scale (Ely EW et al.) by non-ICU researchers who are blinded to the randomization allocation. The delirium evaluation will begin when the patient reaches a Richmond Agitation-Sedation Scale (RASS) score of > -3, in patients who had more than 24 hours of deep sedation
Up to 14 days post end of deep sedation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare mortality at 60 days after randomization
Time Frame: Until 60 days after randomization
To compare the effect of sedation guided by the Bispectral Index (BIS) vs. sedation guided by clinical scales on mortality at 60 days after randomization
Until 60 days after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Italiano de Buenos Aires

Investigators

  • Study Director: Federico Carini, MD, Hospital Italiano de Buenos Aires
  • Study Chair: Sergio Giannasi, MD, Hospital Italiano de Buenos Aires
  • Principal Investigator: Ivan A. Huespe, MD, Hospital Italiano de Buenos Aires

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2019

Primary Completion (Actual)

April 22, 2022

Study Completion (Estimated)

January 1, 2024

Study Registration Dates

First Submitted

February 3, 2019

First Submitted That Met QC Criteria

February 13, 2019

First Posted (Actual)

February 15, 2019

Study Record Updates

Last Update Posted (Actual)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 28, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3880

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data will be made available upon reasonable request.

IPD Sharing Time Frame

The data will be made available at the end of the study, in 2024.

IPD Sharing Access Criteria

All data requirements will be evaluated by the principal investigator and the local Institutional Review Board to ensure compliance with ethical and regulatory guidelines regarding data access and protection

IPD Sharing Supporting Information Type

  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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