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NCT03840577
BIS-Guided Sedation in Critically Ill Patients Under Deep Sedation
NA trial testing Monitorization of sedation by Bispectral Index in Delirium in 99 participants. Status unknown.
22 April 2022
Quick facts
| Lead sponsor | Hospital Italiano de Buenos Aires |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | supportive care |
| Enrollment | 99 |
| Start date | 1 April 2019 |
| Primary completion | 22 April 2022 |
| Estimated completion | 1 January 2024 |
| Sites | 1 location across Argentina |
Drugs / interventions tested
- Monitorization of sedation by Bispectral Index
Conditions studied
- Delirium — all drugs for Delirium →
- Sedative Overdose — all drugs for Sedative Overdose →
Sponsor
Hospital Italiano de Buenos Aires
Who can join
18 and older, any sex, with Delirium or Sedative Overdose. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Comparing Bispectral Index Monitoring vs Clinical Assessment for Deep Sedation in the ICU: Effects on Delirium Reduction and Sedative Drug Doses-A Randomized Trial.
Huespe I, Giunta D, Acosta K, Avila D, et al · · 2024 · cited 6× · PMID 38901489 · DOI 10.1016/j.chest.2024.05.031
Verify or expand the search:
- PubMed search for NCT03840577
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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- NCT07488468 — Quality Improvement Project to Reduce Preoperative Fasting Times Before Elective Procedures · recruiting
- NCT07136207 — Development and Validation of Delirium Recognition Using Computer Vision in Neuro-critical Patients · recruiting
Other Hospital Italiano de Buenos Aires trials
Trials by the same sponsor.
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- NCT07167173 — Predictive Model for Multidrug Resistance in Patients Admitted to the Emergency Department With Sepsis · not yet recruiting
- NCT06683781 — Ventilatory Settings and Monitoring Variables Associated With Weaning Failure in Critically Ill Patients · recruiting
- NCT06573723 — Institutional Registry of Rare Diseases · recruiting
- NCT06609798 — Ultrasound Assessment During Weaning from Mechanical Ventilation · enrolling by invitation
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03840577 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hospital Italiano de Buenos Aires
- Last refreshed: 1 August 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03840577.
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