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Sedation of Mechanically Ventilated Critically Ill Patients: Midazolam Versus Dexmedetomidine

NCT ID: NCT01256866

Last Updated: 2010-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2012-06-30

Brief Summary

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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)

Detailed Description

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Conditions

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Mechanically Ventilated Patients Sedation Dexmedetomidine Midazolam

Keywords

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Dexmedetomidine Midazolam Sedation Mechanical ventilation Critically ill patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DEXMEDETOMIDINE, SEDATION

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

Midazolam, sedation,

Group Type ACTIVE_COMPARATOR

Midazolam

Intervention Type DRUG

Interventions

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Dexmedetomidine

Intervention Type DRUG

Midazolam

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Sao Domingos

OTHER

Sponsor Role lead

Responsible Party

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Hospital Sao Domingos

Locations

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Hospital Sao Domingos

São Luís, Maranhão, Brazil

Site Status RECRUITING

Countries

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Brazil

Facility Contacts

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Jose R Azevedo, MD

Role: primary

Other Identifiers

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hsd130947

Identifier Type: -

Identifier Source: org_study_id