SEDCOM
Trial question
What is the effect of dexmedetomidine for sedation in mechanically ventilated ICU patients?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
50.0% female
50.0% male
N = 366
366 patients (184 female, 182 male).
Inclusion criteria: adult patients intubated and mechanically ventilated for < 96 hours with expected mechanical ventilation for > 24 hours.
Key exclusion criteria: trauma or burns as admitting diagnoses, dialysis, pregnancy or lactation, neuromuscular blockade other than for intubation, epidural or spinal analgesia, serious CNS pathology, acute hepatitis or severe liver disease, unstable angina or acute MI.
Interventions
N=244 dexmedetomidine (0.2-1.4 mcg/kg/hr titrated to achieve light sedation).
N=122 midazolam (0.02-0.1 mg/kg/hr titrated to achieve light sedation).
Primary outcome
Time within target Richmond Agitation and Sedation Scale range
77.3%
75.1%
77.3 %
58.0 %
38.6 %
19.3 %
0.0 %
Dexmedetomidine
Midazolam
No significant
difference ↔
No significant difference in time within the target Richmond Agitation and Sedation Scale range (77.3% vs. 75.1%; AD 2.2%, 95% CI -3.2 to 7.5).
Secondary outcomes
Significant decrease in prevalence of delirium during treatment (54% vs. 76.6%; ARD -22.6, 95% CI -36.01 to -9.19).
Significantly shorter time to extubation (3.7 days vs. 5.6 days; AD -1.9 days, 95% CI -3.35 to -0.45).
No significant difference in length of ICU stay (5.9 days vs. 7.6 days; AD -1.7 days, 95% CI -4.52 to 1.12).
Safety outcomes
No significant differences in all-cause mortality at 30 days, drug discontinuation due to adverse events.
Significant differences in bradycardia (42.2% vs. 18.9%), tachycardia (25.4% vs. 44.3%), and hypertension requiring treatment (18.9% vs. 29.5%).
Conclusion
In adult patients intubated and mechanically ventilated for < 96 hours with expected mechanical ventilation for > 24 hours, dexmedetomidine was not superior to midazolam with respect to time within the target Richmond Agitation and Sedation Scale range.
Reference
Riker RR, Shehabi Y, Bokesch PM et al. Dexmedetomidine vs midazolam for sedation of critically ill patients: a randomized trial. JAMA. 2009 Feb 4;301(5):489-99.
Open reference URL