UnknownNot Applicable

BIS-Guided Sedation in Critically Ill Patients Under Deep Sedation

Argentina99 participantsStarted 2019-04-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Compare delirium and coma free days until 14 days after end of deep sedation

Timeframe: Up to 14 days post end of deep sedation

Compare the doses of sedative drugs received

Timeframe: 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

Timeframe: 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

Trial details

NCT IDNCT03840577

SponsorHospital Italiano de Buenos Aires

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-04-22

View on ClinicalTrials.gov More Delirium trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Compare delirium and coma free days until 14 days after end of deep sedation

Timeframe: Up to 14 days post end of deep sedation

Compare the doses of sedative drugs received

Timeframe: 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

Timeframe: 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