Sedation of Mechanically Ventilated Critically Ill Patients: Midazolam Versus Dexmedetomidine

Hospital Sao Domingos

Status and phase: Unknown; Phase 4

Conditions: Dexmedetomidine; Sedation; Mechanically Ventilated Patients; Midazolam

Treatments: Drug: Midazolam; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT01256866

hsd130947

Details and patient eligibility

About

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)

Enrollment: 146 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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146 participants in 2 patient groups

DEXMEDETOMIDINE, SEDATION

Active Comparator group

Treatment:

Drug: Dexmedetomidine

Midazolam, sedation,

Active Comparator group

Treatment:

Drug: Midazolam