FindTrial
Sign In

Assessment of Sedation in the intensive care unit (ICU): monitoring patients level of consciousness

Use of the consciousness monitor to evaluate Sedoanalgesia in an intensive care unit

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-68mzg3c
Enrollment
Unknown
Registered
2024-04-18
Start date
2024-04-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Conscious Sedation

Interventions

This is a prospective, randomized, unblinded clinical trial. Participants will be randomly divided into two groups: a control group, which will not receive BIS monitoring, and an intervention group, w
F02.463.188.409

Sponsors

Patrícia Nunes dos Santos
Lead Sponsor
Hospital Universitário da Universidade Federal do Piauí- HUUFPI
Collaborator
Universidade Federal do Piauí
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age over 18 years old; female and male sex; mechanical ventilation via endotracheal tube; using continuous intravenous sedation at doses above those recommended

Exclusion criteria

Exclusion criteria: Primary neurological disorders (stroke, hypoxic brain injury, intracranial hemorrhage and traumatic brain injury); use of neuromuscular blockers; infection in the central nervous system; extubation; hemodynamic instability; hypoxia; palliative care; post-myocardial revascularization surgery; refusal of the patient or family member to participate; death

Design outcomes

Primary

MeasureTime frame
Evaluating the effectiveness of consciousness monitoring using the Bispectral Index compared to subjective clinical monitoring;Assess the death rate;Assess the discharge rate;Compare the duration of mechanical ventilation and the length of stay in the Intensive Care Unit (ICU) in the two study groups;Assess adverse effects related to sedation—

Secondary

MeasureTime frame
Evaluate the outcome of pharmaceutical interventions regarding sedoanalgesia based on monitoring the Bispectral Index (BIS);Analyze the consumption of sedatives and analgesics;Assess wake-up time;Analyze the economic impact—

Countries

Brazil

Contacts

Public ContactPatrícia dos Santos

Universidade Federal do Piauí

patricia.dos@ufpi.edu.br+55(86)99956-7729

Outcome results

None listed

Source: REBEC (via WHO ICTRP)