• Laurent Beydon, Adrien Rouxel, Nicolas Camut, Naren Schinkel, Jean-Marc Malinovsky, Christophe Aveline, Emmanuel Marret, Adriana Bildea, Denis Dupoiron, Ngai Liu, Valérie Daniel, Astrid Darsonval, Jean-Marie Chrétien, Laetitia Rault, Jacques Bruna, and Corinne Alberti.
• Pôle d'anesthésie réanimation, LUNAM université, CHU d'Angers, 49000 Angers, France. Electronic address: lbeydon.angers@invivo.edu.
• Anaesth Crit Care Pain Med. 2015 Jun 1; 34 (3): 165-71.

ObjectiveAnxiolytic premedication before non-ambulatory surgery in adult patients may have become of less importance in an era of better preoperative patient information. Moreover, an oral hypnotic given the night before surgery may be as efficient as an anxiolytic for relieving patient anxiety. These two strategies were compared for superiority to a placebo and to each other for non-inferiority.Study DesignDouble-blind, randomized, multicentre study versus placebo. Eight hospitals in France. June 2011 to February 2013.PatientsNon-ambulatory consecutive surgical patients undergoing general surgery.Methods And InterventionsPatients received either zopiclone 7.5mg the night before surgery (n=204), or alprazolam 0.5mg the morning of surgery (n=206) and controls received placebo (n=68). Demographic data, preoperative anxiety, fear of surgery and anaesthesia, and mood were assessed the day before surgery using a visual analogue scale, the Spielberger scale and the APAIS scale. In the operating room, anxiety and comfort were assessed in addition to physiological data.ResultsPreoperative data did not differ between groups. In the operating room, anxiety and comfort were moderate and did not differ significantly between groups on a 1-10 scale (median [25-75 percentile]): zopiclone: 2 [1-4] and 2.5 [1-5]; alprazolam: 2 [1,4] and 2 [1-5]; placebo: 3 [1-5] and 3 [1-5]. The patients who were more anxious preoperatively remained so in the operating room, irrespective of the treatment received (r=0.31, p<0.001). A placebo effect was observed in 38% of patients in the corresponding group. Patients receiving zopiclone reported a significantly better sleep the night before surgery compared to other groups (median: 2 vs. 1, p<0.001).ConclusionsPremedication in non-ambulatory surgery is no more effective than a placebo, owing to the very moderate level of anxiety experienced by patients.Copyright © 2015 Société française d’anesthésie et de réanimation (Sfar). Published by Elsevier Masson SAS. All rights reserved.

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