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NCT01256866 Clinical Trial

Sedation of Mechanically Ventilated Critically Ill Patients: Midazolam Versus Dexmedetomidine

Sedation Clinical Trial

Official title:
Sedation of Mechanically Ventilated Critically Ill Patients: Midazolam Versus Dexmedetomidine

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01256866
Other study ID # hsd130947
Secondary ID
Status Recruiting
Phase Phase 4
First received December 8, 2010
Last updated December 8, 2010
Start date November 2010
Est. completion date June 2012

Study information
Verified date November 2010
Source Hospital Sao Domingos
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial 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)

Recruitment information / eligibility
Status Recruiting
Enrollment 146
Est. completion date June 2012
Est. primary completion date October 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Dexmedetomidine

• Midazolam

Locations
Country Name City State
Brazil Hospital Sao Domingos Sao Luis Maranhao

Sponsors (1)
Lead Sponsor Collaborator
Hospital Sao Domingos

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of delirium
Secondary PERCENTAGE OF TIME WITHIN THE TARGET SEDATION
See also
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Completed NCT02171910 - Doxapram as an Additive to Propofol Sedation in Sedation for ERCP Phase 4
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