Dexmedetomidine, Mechanically Ventilated Patients, Midazolam, Sedation
Conditions
Keywords
Dexmedetomidine, Midazolam, Sedation, Mechanical ventilation, Critically ill patients
Brief summary
The aim of this prospective randomized study is to compare the safety and efficacy of two strategies for sedation of critically ill patients submitted to mechanical ventilation: continuous intravenous infusion of dexmedetomidine versus intravenous bolus of midazolam. The two groups will be compared as to the incidence of of delirium, evaluated with the Confusion Assessment Method for ICU (CAM-ICU) and the percentage of time within the target sedation using the Richmond Agitation-Sedation Scale (RAAS).Eligible patients will be 18 years or older intubated and mechanically ventilated for less than 48 hours prior to start of study drug and anticipated ventilation duration of at least 48 hours. Calculated sample size is 146 patients (73 patients in each group)
Interventions
DRUGDexmedetomidine
DRUGMidazolam
Sponsors
Hospital Sao Domingos
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Adult mechanically ventilated, critically ill patients
Exclusion criteria
* pregnancy or lactation, severe liver disease, hearth rate less than 50, hypotension despite volemic repletion and vasoactive drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of delirium | — |
Secondary
| Measure | Time frame |
|---|---|
| PERCENTAGE OF TIME WITHIN THE TARGET SEDATION | — |
Countries
Brazil
Outcome results
None listed