Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT03840577
Study type Interventional
Source Hospital Italiano de Buenos Aires
Contact
Status Active, not recruiting
Phase N/A
Start date April 1, 2019
Completion date January 1, 2024

See also
  Status Clinical Trial Phase
Completed NCT04551508 - Delirium Screening 3 Methods Study
Recruiting NCT05891873 - Delirium in the (Neuro)Intensive/Critical Care in the Adult and Paediatric Czech Populations
Recruiting NCT06027788 - CTSN Embolic Protection Trial N/A
Recruiting NCT04792983 - Cognition and the Immunology of Postoperative Outcomes
Recruiting NCT06194474 - Study on Biomarkers of Postoperative Delirium in Elderly Cardiac Surgery Patients
Completed NCT03095417 - Improving the Recovery and Outcome Every Day After the ICU N/A
Completed NCT05395559 - Prevalence and Recognition of Cognitive Impairment in Hospitalized Patients: a Flash Mob Study
Terminated NCT03337282 - Incidence and Characteristics of Postoperative Cognitive Dysfunction in Elderly Quebec Francophone Patients
Not yet recruiting NCT04846023 - Pediatric Delirium Screening in the PICU Via EEG N/A
Not yet recruiting NCT04538469 - Absent Visitors: The Wider Implications of COVID-19 on Non-COVID Cardiothoracic ICU Patients, Relatives and Staff
Not yet recruiting NCT03807388 - ReMindCare App for Patients From First Episode of Psychosis Unit. N/A
Withdrawn NCT02673450 - PER3 Clock Gene Polymorphism, Clock Gene Expression and Delirium in the Intensive Care Unit.
Recruiting NCT03256500 - Transcranial Direct Current Stimulation for the Treatment of Delirium N/A
Completed NCT02890927 - Geriatric-CO-mAnagement for Cardiology Patients in the Hospital N/A
Not yet recruiting NCT02892968 - ED Ultrasonographic Regional Anesthesia to Prevent Incident Delirium in Hip Fracture Patients N/A
Recruiting NCT03165539 - Cerebral Oxygen Desaturation and Post-Operative Delirium in Thoracic Surgical Patients
Completed NCT02554253 - The Impact of Ketamine on Postoperative Cognitive Dysfunction, Delirium, and Renal Dysfunction Phase 2
Completed NCT02518646 - DElirium prediCtIon in the intenSIve Care Unit: Head to Head comparisON of Two Delirium Prediction Models N/A
Recruiting NCT02305589 - The Clinical Changes Before and After Sugammadex in the Patients Undergoing Hip Surgery on the Aspect of Delirium N/A
Completed NCT02628925 - Nu-DESC DK: The Danish Version of the Nursing Delirium Screening Scale N/A