Ramelteon for prevention of post-operative delirium: a randomized controlled trial in patients undergoing elective pulmonary thromboendarterectomy
Abstract
Objective: To assess the efficacy of ramelteon in preventing delirium, an acute neuropsychiatric condition associated with increased morbidity and mortality, in the peri-operative, Intensive Care Unit (ICU) setting. Design: Parallel-arm, randomized, double-blinded, placebo controlled trial Setting: Academic medical center in La Jolla, California. Patients: Patients ≥ 18 years undergoing elective pulmonary thromboendarterectomy. Interventions: Ramelteon 8 mg or matching placebo starting the night prior to surgery and for a maximum of six nights while in the ICU. Measurements: Incident delirium was measured twice daily using the Confusion Assessment Method. The safety outcome was coma-free days assessed by the Richmond Agitation Sedation Scale. Main Results: 120 participants were enrolled and analysis completed in 117. Delirium occurred in 22/58 patients allocated to placebo vs. 19/59 allocated to ramelteon (RR 0.8, 95% CI 0.5 to 1.4; p = 0.516). Delirium duration, as assessed by the number of delirium-free days was also similar in both groups (placebo median 2 days (IQR 2 to 3) vs. ramelteon 3 (2 to 5); p=0.181). Coma-free days was also similar between groups (median placebo days 2 (IQR 1 to 3) vs. ramelteon 3 (2 to 4) days; p=0.210). We found no difference in ICU LOS [median 4 (IQR 3 to 5) vs. 4 (3 to 6) days, p = 0.349] or in-hospital mortality, (4 vs. 3 deaths, relative risk ratio 0.7, 95% CI 0.2 to 3.2; p=0.717), all placebo vs. ramelteon, respectively. Conclusions:…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 120 participants or records.
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