title: Sedative premedication before surgery--A multicentre randomized study versus placebo.
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.
  
  
  METHODS
  Double-blind, randomized, multicentre study versus placebo. Eight hospitals in France. June 2011 to February 2013.
  
  
  METHODS
  Non-ambulatory consecutive surgical patients undergoing general surgery.
  
  
  METHODS
  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.affiliation: Pôle d'anesthésie réanimation, LUNAM université, CHU d'Angers, 49000 Angers, France. Electronic address: lbeydon.angers@invivo.edu.
authors.forename: Laurent
authors.initials: L
authors.lastname: Beydon
authors.affiliation: Pôle d'anesthésie réanimation, LUNAM université, CHU d'Angers, 49000 Angers, France.
authors.forename: Adrien
authors.initials: A
authors.lastname: Rouxel
authors.affiliation: Pôle d'anesthésie réanimation, LUNAM université, CHU d'Angers, 49000 Angers, France.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Camut
authors.affiliation: Clinique Saint-Leonard, 49800 Trélazé, France.
authors.forename: Naren
authors.initials: N
authors.lastname: Schinkel
authors.affiliation: Département d'anesthésie réanimation, hôpital Maison-Blanche, 51100 Reims, France.
authors.forename: Jean-Marc
authors.initials: JM
authors.lastname: Malinovsky
authors.affiliation: Polyclinique Sévigné, 35150 Cesson-Sevigné, France.
authors.forename: Christophe
authors.initials: C
authors.lastname: Aveline
authors.affiliation: Département d'anesthésie réanimation, hôpital Tenon, Assistance Publique-Hôpitaux de Paris, 75020 Paris, France.
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Marret
authors.affiliation: Service d'anesthésie, centre hospitalier, 74000 Le Mans, France.
authors.forename: Adriana
authors.initials: A
authors.lastname: Bildea
authors.affiliation: Institut de cancérologie de l'Ouest, 49000 Angers, France.
authors.forename: Denis
authors.initials: D
authors.lastname: Dupoiron
authors.affiliation: Service d'anesthésie, hôpital Foch, 92150 Suresnes, France.
authors.forename: Ngai
authors.initials: N
authors.lastname: Liu
authors.affiliation: Pharmacie, LUNAM université, CHU d'Angers, 49000 Angers, France.
authors.forename: Valérie
authors.initials: V
authors.lastname: Daniel
authors.affiliation: Pharmacie, LUNAM université, CHU d'Angers, 49000 Angers, France.
authors.forename: Astrid
authors.initials: A
authors.lastname: Darsonval
authors.affiliation: Centre de recherche clinique, LUNAM université, CHU d'Angers, 49000 Angers, France.
authors.forename: Jean-Marie
authors.initials: JM
authors.lastname: Chrétien
authors.affiliation: Centre de recherche clinique, LUNAM université, CHU d'Angers, 49000 Angers, France.
authors.forename: Laetitia
authors.initials: L
authors.lastname: Rault
authors.affiliation: Clinique Saint-Leonard, 49800 Trélazé, France.
authors.forename: Jacques
authors.initials: J
authors.lastname: Bruna
authors.affiliation: Unité d'épidémiologie clinique, université Paris Diderot, PRES Sorbonne Paris Cité, hôpital Robert-Debré, Assistance Publique-Hôpitaux de Paris, 75019 Paris, France.
authors.forename: Corinne
authors.initials: C
authors.lastname: Alberti
mesh_terms: D000293:Adolescent; D000328:Adult; D000339:Affect; D000368:Aged; D000525:Alprazolam; D014151:Anti-Anxiety Agents / Q000627:therapeutic use; D001007:Anxiety / Q000523:psychology; D053961:Azabicyclo Compounds; D004311:Double-Blind Method; D005239:Fear / Q000523:psychology; D005260:Female; D005602:France; D006801:Humans; D006993:Hypnotics and Sedatives; D008297:Male; D008875:Middle Aged; D010879:Piperazines; D011229:Preanesthetic Medication; D055815:Young Adult
chemical_list: D014151:Anti-Anxiety Agents; D053961:Azabicyclo Compounds; D006993:Hypnotics and Sedatives; D010879:Piperazines; C515050:zopiclone; D000525:Alprazolam
keywords: Anxiety; Benzodiazepines; Premedication; Randomized controlled trial; Surgery