Enteral versus intravenous approach for the sedation of critically ill patients: A randomized and controlled trial 11 Medical and Health Sciences 1103 Clinical Sciences

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 FerrariGaetano Iapichino, Alberto Morabito, Martin Langer, Franco Valenza, Roberto Malacrida, Marco Rambaldi, Paolo Spanu, Stefania Anania, Elisa Andrighi, Alessandra Di Carlo, Federica Martinetti, Serena Barello, Andrea Noto, Gianfranco Capello, Bruno Sabatelli, Giovanni Brenna, Morena Astori, Pietro Placido, Luciano Gattinoni, Alessandro Protti, Francesca Pagan, Virna Berto, Paola Roselli, Giulio Ronzoni, Eduardo Beck, Maurizio Gaiotto, Danilo Radrizzani, Luca Ferla, Riccardo Giudici, Laura Merlini, Antonio Pesenti, Alessia La Bruna, Emanuele Rezoagli, Alberto Lucchini, Antonio Braschi, Thekla Niebel, Marina Selvini, Sergio Cortesi, Attilio Quaini, Giorgio Iotti, Enrico Contri, Antonella Sacchi, Sergio Livigni, Giuseppe Naretto, Alessandro Deprado, Virna Venturi Degli Esposti, Pietro Caironi, Giulio Radeschi, Lorenzo Odetto, Daniele Ferrero, Stefano Cognolato, Roberto Penso, Roberta Vacchelli, Silvano Cardellino, Edda Bosco, Anna Bresciani, Ivana Pozzo, Annachiara Alessio, Vanessa Clarindo Rodrigues, Edna Biase, Nicoletta Vivaldi, Antonella Nava, Francesco Ponzetta, Lucilla Bavutti, Paola Martina, Beatriz Palacios, Giancarla Bergonzini

Research output: Contribution to journalArticlepeer-review

Abstract

Background: ICU 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. Methods: This 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. Results: There 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). Conclusions: Although 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 registration: ClinicalTrials.gov, NCT01360346. Registered on 25 March 2011.

Original languageEnglish
Article number3
JournalCritical Care
Volume23
Issue number1
DOIs
Publication statusPublished - Jan 7 2019

Keywords

  • Hydroxyzine
  • Hypnotics and sedatives
  • Melatonin
  • Nursing education research
  • Patient care planning

ASJC Scopus subject areas

  • Critical Care and Intensive Care Medicine

Fingerprint Dive into the research topics of 'Enteral versus intravenous approach for the sedation of critically ill patients: A randomized and controlled trial 11 Medical and Health Sciences 1103 Clinical Sciences'. Together they form a unique fingerprint.

Cite this