6/29/23, 11:42 PM SKY-DEX Pathway Feedback Search Clinical Topics Home Studies SKY DEX 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 N = 100 64.0% male 100 patients (36 female, 64 male) Inclusion criteria: delirium-free critically ill adults 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 g/kg/hour, titrated by 0.1 g/kg/hour every 15 minutes until a goal Richmond Agitation and Sedation Scale score of -1 or maximum rate of 0.7 g/kg/hour reached) N=50 placebo (equivalent mL/hour of the placebo until ICU discharge) Primary outcome Delirium-free during intensive care unit stay 80.0 % 80 60.0 % 54 https://web.pathway.md/studies/recVe3VLZTJy2mhcf 1/2 6/29/23, 11:42 PM SKY-DEX Pathway 40.0 % Significant decrease 20.0 % NNH = 4 0.0 % Nocturnal dexmedetomidine Placebo 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 vs. 10; AD 0.02, 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 adults 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. Open reference URL https://web.pathway.md/studies/recVe3VLZTJy2mhcf 2/2