• Giovanni Mistraletti, Michele Umbrello, Silvia Salini, Paolo Cadringher, Paolo Formenti, Davide Chiumello, Cristina Villa, Riccarda Russo, Silvia Francesconi, Federico Valdambrini, Giacomo Bellani, Alessandra Palo, Francesca Riccardi, Enrica Ferretti, Maurilio Festa, Anna Maria Gado, Martina Taverna, Cristina Pinna, Alessandro Barbiero, Pier Alda Ferrari, Gaetano Iapichino, and SedaEN investigators.
• Dipartimento di Fisiopatologia Medico-Chirurgica e dei Trapianti, Università degli Studi di Milano, A.O. San Paolo - Polo Universitario, Via A. Di Rudinì, 8, 20142, Milano, Italy. giovanni.mistraletti@unimi.it.
• Crit Care. 2019 Jan 7; 23 (1): 3.

BackgroundICU patients must be kept conscious, calm, and cooperative even during the critical phases of illness. Enteral administration of sedative drugs might avoid over sedation, and would be as adequate as intravenous administration in patients who are awake, with fewer side effects and lower costs. This study compares two sedation strategies, for early achievement and maintenance of the target light sedation.MethodsThis was a multicenter, single-blind, randomized and controlled trial carried out in 12 Italian ICUs, involving patients with expected mechanical ventilation duration > 72 h at ICU admission and predicted mortality > 12% (Simplified Acute Physiology Score II > 32 points) during the first 24 h on ICU. Patients were randomly assigned to receive intravenous (midazolam, propofol) or enteral (hydroxyzine, lorazepam, and melatonin) sedation. The primary outcome was percentage of work shifts with the patient having an observed Richmond Agitation-Sedation Scale (RASS) = target RASS ±1. Secondary outcomes were feasibility, delirium-free and coma-free days, costs of drugs, length of ICU and hospital stay, and ICU, hospital, and one-year mortality.ResultsThere were 348 patients enrolled. There were no differences in the primary outcome: enteral 89.8% (74.1-100), intravenous 94.4% (78-100), p = 0.20. Enteral-treated patients had more protocol violations: n = 81 (46.6%) vs 7 (4.2%), p < 0.01; more self-extubations: n = 14 (8.1%) vs 4 (2.4%), p = 0.03; a lighter sedative target (RASS = 0): 93% (71-100) vs 83% (61-100), p < 0.01; and lower total drug costs: 2.39 (0.75-9.78) vs 4.15 (1.20-20.19) €/day with mechanical ventilation (p = 0.01).ConclusionsAlthough enteral sedation of critically ill patients is cheaper and permits a lighter sedation target, it is not superior to intravenous sedation for reaching the RASS target.Trial RegistrationClinicalTrials.gov, NCT01360346 . Registered on 25 March 2011.

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