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Original Investigation
March 3, 2015

Effect of Sedative Premedication on Patient Experience After General Anesthesia: A Randomized Clinical Trial

Author Affiliations
  • 1Service d’Anesthésie Réanimation, Hôpital de la Timone Adulte, Marseille, France
  • 2Laboratoire Universitaire EA 3279, Santé Publique et Maladies Chroniques, Université Aix-Marseille, Marseille, France
  • 3Service d’Anesthésie, Institut du Cancer, Université Montpellier 1, Montpellier, France
  • 4Service d’Anesthésie Réanimation, Hôpital Archet, Université Nice Sophia-Antipolis, Nice, France
  • 5Service d’Anesthésie, Pôle ARDU, Hôpital Universitaire Carémeau, Nîmes, Université Montpellier 1, Montpellier, France
  • 6Expertise Pharmaceutique, Hôpital de la Timone Adulte, Université Aix, Marseille, France
  • 7Unité d’Aide Méthodologique, Direction de la Recherche Clinique, AP-HM, Marseille, France
  • 8Service d’Anesthésie Réanimation, Hôpital Nord, Pavillon de l’Etoile, Université Aix-Marseille, Marseille, France
JAMA. 2015;313(9):916-925. doi:10.1001/jama.2015.1108
Abstract

Importance  Sedative premedication is widely administered before surgery, but little clinical evidence supports its use.

Objective  To assess the efficacy of sedative premedication on perioperative patient experience.

Design, Setting, and Participants  A randomized clinical trial, the PremedX study, enrolled 1062 adult patients who were younger than 70 years and had been scheduled for various elective surgeries under general anesthesia at 5 French teaching hospitals (in Marseille, Montpellier, Nimes, and Nice) between January 2013 and June 2014. Neurosurgery, obstetrical, cardiac, and outpatient surgery were excluded.

Interventions  Patients were randomized to 3 groups of 354 participants each to receive 2.5 mg of lorazepam, no premedication, or placebo.

Main Outcomes and Measures  The primary outcome was perioperative patient experience assessed 24 hours after surgery with a validated questionnaire (Evaluation du Vécu de l'Anesthésie Generale; EVAN-G) describing 6 domains of satisfaction and a global index (score range, 0-100; high scores represent high satisfaction); secondary outcomes included time to extubation and early cognitive recovery. A subgroup analysis was planned a priori in patients with a high level of preoperative anxiety.

Results  Premedication with lorazepam did not improve the EVAN-G mean global index for overall level of patient satisfaction (72 [95% CI, 70-73]; n = 330) compared with no premedication (73 [95% CI, 71-74]; n = 319) or placebo (71 [95% CI, 70-73]; n = 322) (P = .38). Among patients with heightened preoperative anxiety, there were no significant differences found in the EVAN-G mean global index between the lorazepam group (68 [95% CI, 65-72]; n = 87) and the no premedication group (73 [95% CI, 69-77]; n = 57) or the placebo group (70 [95% CI, 67-72]; n = 87) (P = .18). Time to extubation was 17 minutes (95% CI, 14-20 minutes) in the lorazepam group, 12 minutes (95% CI, 11-13 minutes) for the no premedication group, and 13 minutes (95% CI, 12-14 minutes) for the placebo group (P < .001) and the rate of early cognitive recovery was 51% (95% CI, 45%-56%), 71% (95% CI, 66%-76%), and 64% (95% CI, 59%-69%), respectively (P < .001).

Conclusions and Relevance  Among patients undergoing elective surgery under general anesthesia, sedative premedication with lorazepam compared with placebo or no premedication did not improve the self-reported patient experience the day after surgery, but was associated with modestly prolonged time to extubation and a lower rate of early cognitive recovery. The findings suggest a lack of benefit with routine use of lorazepam as sedative premedication in patients undergoing general anesthesia.

Trial Registration  clinicaltrials.gov Identifier: NCT01901003

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