Laurent Beydon1, Adrien Rouxel2, Nicolas Camut2, Naren Schinkel3, Jean-Marc Malinovsky4, Christophe Aveline5, Emmanuel Marret6, Adriana Bildea7, Denis Dupoiron8, Ngai Liu9, Valérie Daniel10, Astrid Darsonval10, Jean-Marie Chrétien11, Laetitia Rault11, Jacques Bruna3, Corinne Alberti12. 1. Pôle d'anesthésie réanimation, LUNAM université, CHU d'Angers, 49000 Angers, France. Electronic address: lbeydon.angers@invivo.edu. 2. Pôle d'anesthésie réanimation, LUNAM université, CHU d'Angers, 49000 Angers, France. 3. Clinique Saint-Leonard, 49800 Trélazé, France. 4. Département d'anesthésie réanimation, hôpital Maison-Blanche, 51100 Reims, France. 5. Polyclinique Sévigné, 35150 Cesson-Sevigné, France. 6. Département d'anesthésie réanimation, hôpital Tenon, Assistance Publique-Hôpitaux de Paris, 75020 Paris, France. 7. Service d'anesthésie, centre hospitalier, 74000 Le Mans, France. 8. Institut de cancérologie de l'Ouest, 49000 Angers, France. 9. Service d'anesthésie, hôpital Foch, 92150 Suresnes, France. 10. Pharmacie, LUNAM université, CHU d'Angers, 49000 Angers, France. 11. Centre de recherche clinique, LUNAM université, CHU d'Angers, 49000 Angers, France. 12. Unité d'épidémiologie clinique, université Paris Diderot, PRES Sorbonne Paris Cité, hôpital Robert-Debré, Assistance Publique-Hôpitaux de Paris, 75019 Paris, France.
Abstract
OBJECTIVE:Anxiolytic 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 DESIGN: Double-blind, randomized, multicentre study versus placebo. Eight hospitals in France. June 2011 to February 2013. PATIENTS: Non-ambulatory consecutive surgical patients undergoing general surgery. METHODS AND INTERVENTIONS: Patients 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. RESULTS: Preoperative 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). CONCLUSIONS: Premedication in non-ambulatory surgery is no more effective than a placebo, owing to the very moderate level of anxiety experienced by patients.
RCT Entities:
OBJECTIVE: Anxiolytic 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 patientanxiety. These two strategies were compared for superiority to a placebo and to each other for non-inferiority. STUDY DESIGN: Double-blind, randomized, multicentre study versus placebo. Eight hospitals in France. June 2011 to February 2013. PATIENTS: Non-ambulatory consecutive surgical patients undergoing general surgery. METHODS AND INTERVENTIONS:Patients 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. RESULTS: Preoperative 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). CONCLUSIONS: Premedication in non-ambulatory surgery is no more effective than a placebo, owing to the very moderate level of anxiety experienced by patients.
Authors: Milena D Stojanovic; Danica Z Markovic; Anita Z Vukovic; Vesna D Dinic; Aleksandar N Nikolic; Tijana G Maricic; Radmilo J Janković Journal: Front Med (Lausanne) Date: 2018-01-19
Authors: Frank Euteneuer; Stefan Kampmann; Stephen Rienmüller; Stefan Salzmann; Dirk Rüsch Journal: BMC Psychiatry Date: 2022-03-17 Impact factor: 3.630
Authors: François Labaste; Fabrice Ferré; Hélène Combelles; Valentin Rey; Jean-Christophe Foissac; Anne Senechal; Jean-Marie Conil; Vincent Minville Journal: Nurs Open Date: 2019-07-11