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JAMA. 2015 Mar 3;313(9):916-25. doi: 10.1001/jama.2015.1108.

Effect of sedative premedication on patient experience after general anesthesia: a randomized clinical trial.

Author information

1
Service d'Anesthésie Réanimation, Hôpital de la Timone Adulte, Marseille, France.
2
Laboratoire Universitaire EA 3279, Santé Publique et Maladies Chroniques, Université Aix-Marseille, Marseille, France.
3
Service d'Anesthésie, Institut du Cancer, Université Montpellier 1, Montpellier, France.
4
Service d'Anesthésie Réanimation, Hôpital Archet, Université Nice Sophia-Antipolis, Nice, France.
5
Service d'Anesthésie, Pôle ARDU, Hôpital Universitaire Carémeau, Nîmes, Université Montpellier 1, Montpellier, France.
6
Expertise Pharmaceutique, Hôpital de la Timone Adulte, Université Aix, Marseille, France.
7
Unité d'Aide Méthodologique, Direction de la Recherche Clinique, AP-HM, Marseille, France.
8
Service d'Anesthésie Réanimation, Hôpital Nord, Pavillon de l'Etoile, Université Aix-Marseille, Marseille, France.

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.

PMID:
25734733
DOI:
10.1001/jama.2015.1108
[Indexed for MEDLINE]

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