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Clinical Trials/NCT01256866
NCT01256866
Unknown
Phase 4

Sedation of Mechanically Ventilated Critically Ill Patients: Midazolam Versus Dexmedetomidine

Hospital Sao Domingos1 site in 1 country146 target enrollmentNovember 2010

Overview

Phase
Phase 4
Intervention
Dexmedetomidine
Conditions
Mechanically Ventilated Patients
Sponsor
Hospital Sao Domingos
Enrollment
146
Locations
1
Primary Endpoint
Incidence of delirium
Last Updated
15 years ago

Overview

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)

Registry
clinicaltrials.gov
Start Date
November 2010
End Date
June 2012
Last Updated
15 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Eligibility Criteria

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

Arms & Interventions

DEXMEDETOMIDINE, SEDATION

Intervention: Dexmedetomidine

Midazolam, sedation,

Intervention: Midazolam

Outcomes

Primary Outcomes

Incidence of delirium

Secondary Outcomes

  • PERCENTAGE OF TIME WITHIN THE TARGET SEDATION

Study Sites (1)

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