SKY-DEX
Trial question
What is the role of low-dose nocturnal dexmedetomidine in critically ill adults during ICU stay?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
36.0% female
64.0% male
N = 100
100 patients (36 female, 64 male).
Inclusion criteria: delirium-free critically ill adult patients receiving sedatives.
Key exclusion criteria: presence of delirium, history of irreversible brain disease consistent with severe dementia, admitted with a primary neurologic condition or injury, acute alcohol withdrawal requiring benzodiazepine administration, history of hepatic encephalopathy or end-stage liver disease, current treatment with dexmedetomidine or clonidine, expected death within 24 hours.
Interventions
N=50 nocturnal dexmedetomidine (intravenous dose of 0.2 mcg/kg/hr, titrated by 0.1 mcg/kg/hr every 15 minutes until a goal Richmond Agitation and Sedation Scale score of -1 or maximum rate of 0.7 mcg/kg/hr reached).
N=50 placebo (equivalent mL/hr of the placebo until ICU discharge).
Primary outcome
Delirium-free during intensive care unit stay
80%
54%
80.0 %
60.0 %
40.0 %
20.0 %
0.0 %
Nocturnal
dexmedetomidine
Placebo
Significant
decrease ▼
NNH = 3
Significant decrease in delirium-free during the ICU stay (80% vs. 54%; RR 0.44, 95% CI 0.23 to 0.82).
Secondary outcomes
Significant increase in days free of delirium in the ICU (8 days vs. 6 days; AD 2 days, 95% CI 0.81 to 3.19).
Significant increase in Leeds Sleep Evaluation Questionnaire score (10 points vs. 10 points; AD 0.02 points, 95% CI 0.42 to 1.92).
Significant decrease in the rate of total proportion of days spent with coma (12% vs. 19%; RR 0.63, 95% CI 0.26 to 1).
Safety outcomes
No significant differences in hypotension, bradycardia, death in the hospital.
Significant difference in severe pain (40% vs. 66%).
Conclusion
In delirium-free critically ill adult patients receiving sedatives, nocturnal dexmedetomidine was superior to placebo with respect to a delirium-free during the ICU stay.
Reference
Yoanna Skrobik, Matthew S Duprey, Nicholas S Hill et al. Low-Dose Nocturnal Dexmedetomidine Prevents ICU Delirium. A Randomized, Placebo-controlled Trial. Am J Respir Crit Care Med. 2018 May 1;197(9):1147-1156.
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