Sedation of Mechanically Ventilated Critically Ill Patients: Midazolam Versus Dexmedetomidine

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Hospital Sao Domingos.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hospital Sao Domingos
ClinicalTrials.gov Identifier:
NCT01256866
First received: December 8, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted
  Purpose

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)


Condition Intervention Phase
Mechanically Ventilated Patients
Sedation
Dexmedetomidine
Midazolam
Drug: Dexmedetomidine
Drug: Midazolam
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Sedation of Mechanically Ventilated Critically Ill Patients: Midazolam Versus Dexmedetomidine

Resource links provided by NLM:


Further study details as provided by Hospital Sao Domingos:

Primary Outcome Measures:
  • Incidence of delirium

Secondary Outcome Measures:
  • PERCENTAGE OF TIME WITHIN THE TARGET SEDATION

Estimated Enrollment: 146
Study Start Date: November 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: DEXMEDETOMIDINE, SEDATION Drug: Dexmedetomidine
Active Comparator: Midazolam, sedation, Drug: Midazolam

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01256866

Locations
Brazil
Hospital Sao Domingos Recruiting
Sao Luis, Maranhao, Brazil, 65060-100
Contact: Jose R Azevedo, MD    55 98 32168110    jrazevedo@elo.com.br   
Principal Investigator: Jose R Azevedo, MD         
Sub-Investigator: Carla C Oliveira, RN         
Sponsors and Collaborators
Hospital Sao Domingos
  More Information

No publications provided

Responsible Party: Ethics Committee, Hospital Sao Domingos
ClinicalTrials.gov Identifier: NCT01256866     History of Changes
Other Study ID Numbers: hsd130947
Study First Received: December 8, 2010
Last Updated: December 8, 2010
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Hospital Sao Domingos:
Dexmedetomidine
Midazolam
Sedation
Mechanical ventilation
Critically ill patients

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes
Midazolam
Dexmedetomidine
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents

ClinicalTrials.gov processed this record on July 23, 2014