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Clinical Trials: Dexmedetomidine vs. Midazolam for Facilitating Extubation in Critically Ill Medical and Surgical ICU Patients: A Randomized, Double-Blind Study


Dexmedetomidine vs. Midazolam for Facilitating Extubation in Critically Ill Medical and Surgical ICU Patients: A Randomized, Double-Blind Study

Trial Focus

Trial Focus

Drugs (Pharmacology), Intensive Care/Critical Care, Lungs & Respiratory


The purpose of this randomized, double-blind study is to evaluate the utility of transitioning benzodiazepine sedation to dexmedetomidine in medical or surgical ICU patients requiring sedation when tracheal extubation is nearing.
50 medical or surgical ICU patients requiring sedation with benzodiazepine therapy and qualifying for daily awakenings will be randomized in a double-blind manner to receive additional midazolam or dexmedetomidine. This study is unique because midazolam or dexmedetomidine will be added, in a blinded fashion, to existing sedation and analgesia in an effort to decrease or possibly discontinue these therapies. The practice of daily discontinuation of sedation and analgesia will be applied to all existing and experimental regimens.
The specific objectives of this study are to determine if transitioning conventional sedation to dexmedetomidine facilitates tracheal extubation, shortens ventilator time, reduces doses of conventional sedatives and analgesics, maintains patient comfort and safety, and alters the total cost of sedation.
Consent will be provided by the next of kin or legally authorized representative within 24 hours of the subject qualifying for daily awakenings.
The study is supported by an investigator-initiated grant from Hospira.

IRB Protocol #


Trial Status

In Progress


Robert MacLaren PharmD at 303-724-2622 or

Eligibility and Other Participant Information

Inclusion Criteria
•Patients requiring mechanical ventilation in the medical or surgical ICUs and currently receiving lorazepam or midazolam by continuous infusion for the purpose of sedation therapy.
•Anticipated duration of continuous sedation ?12 hours with the level of sedation expected to be maintained at Riker sedation-agitation score(s) of 3 - 4.
•Patients qualifying for daily awakenings as determined by all of the following: fraction of inspired oxygen (FiO2) =70% or positive end expiratory pressure (PEEP) =14 cm H2O, hemodynamically stable, and NOT receiving pharmacologic neuromuscular blockade.
•Informed consent within 24 hours of qualifying for daily awakenings.

Exclusion Criteria
•Patients < 18 years of age or > 85 years of age.
•Patients receiving intermittent or "as needed" administration of lorazepam or midazolam.
•Patients receiving lorazepam or midazolam for purposes other than sedation (e.g. seizure control).
•Patients receiving epidural administration of medication(s).
•Patients with Childs-Pugh class C liver disease.
•Comatose patients by metabolic or neurologic affectation.
•Patients with active myocardial ischemia or second- or third-degree heart block.
•Moribund state with planned withdrawal of life support.
•Patients with known or suspected severe adverse reactions to midazolam (or any other benzodiazepine) or dexmedetomidine (or clonidine).
•Patients with alcohol abuse within six months of study eligibility.
•Pregnant females or females suspected of being pregnant.