N/A N=23 Randomized Quadruple-blind Treatment

Dexmedetomidine Versus Midazolam for Facilitating Extubation

Critical Illness

Bottom Line

View on ClinicalTrials.gov: NCT00744380 ↗

Enrolled (actual)

Serious AEs

4.4%

Results posted

Sep 2016

Primary outcome: Primary: Time From Study Drug Initiation to Tracheal Extubation — 2.9; 3.4 days — p=0.8

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Midazolam (Drug); Dexmedetomidine (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Colorado, Denver
Primary completion: Oct 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Time From Study Drug Initiation to Tracheal Extubation	2.9; 3.4	0.8
SECONDARY Cumulative Doses of Conventional Sedatives and Analgesics	29; 65.3; 126.9; 65.3; 5.4; 4.1	0.25
SECONDARY The Quality of Sedation (Assessed by the Riker Sedation-Agitation Score) and Analgesia (Assessed by the Pain Assessment Behavioral Score)	5.4; 4.1; 84.1; 71.2; 6.6; 27.1	0.75
SECONDARY Sedation-related Adverse Effects	6; 10; 7; 7; 5; 7	>0.1
SECONDARY ICU Experiences by Administering ICU Stressful Experiences Questionnaire (ICU-SEQ)	8.5; 18.5	0.015 sig
SECONDARY Duration of Study Drug Administration	3; 3.5	0.5
SECONDARY Manifestations of Acute Stress Disorder by Impact of Event Scale - Revised (IES-R)	13; 36	0.029 sig
SECONDARY Hospital Anxiety and Depression Scale (HADS) Score	3; 6; 6; 4	>0.1

Summary

The purpose of this randomized, double-blind study is to evaluate the utility, safety, and cost of transitioning benzodiazepine sedation to dexmedetomidine in medical or surgical intensive care unit (ICU) patients requiring sedation when tracheal extubation is nearing. Fifty medical or surgical ICU patients requiring sedation with existing benzodiazepine therapy and qualifying for daily awakenings will be randomized in a double-blind manner to receive additional midazolam or dexmedetomidine.

Eligibility Criteria

Inclusion Criteria

Patients requiring mechanical ventilation in the medical or surgical ICUs.
Currently receiving lorazepam or midazolam by continuous infusion for the purpose of sedation therapy.
Sedation in these ICUs is provided using an ICU-wide order form that preferentially uses either lorazepam or midazolam with the infusion rate titrated by the bedside nurse to the desired Riker sedation-agitation score(s). Continuous analgesia is provided with fentanyl only with the infusion rate titrated by the bedside nurse to PABS ≤ 3 .
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 cmH2O,
hemodynamically stable, and
NOT receiving pharmacologic neuromuscular blockade.
Informed consent and HIPAA authorization within 24 hours of qualifying for daily awakenings.

Exclusion Criteria

Patients 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00744380). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.