Lorazepam does not improve the quality of recovery in day-case surgery patients: a randomised placebo-controlled clinical trial

Eur J Anaesthesiol. 2013 Dec;30(12):743-51. doi: 10.1097/EJA.0b013e328361d395.


Background: In day-case surgery, the effects of the anxiolytic lorazepam as premedication on the quality of postoperative recovery are unknown.

Objective: To evaluate whether lorazepam as a premedication beneficially affects quality of recovery (primary outcome) and psychological manifestations (secondary outcome) after day-case surgery.

Design: A randomised, double-blind, placebo-controlled clinical trial.

Setting: Single tertiary centre.

Inclusion criteria: day-case surgery; age at least 18 years.

Exclusion criteria: insufficient knowledge of the Dutch language; intellectual disability; ophthalmology surgery; extracorporeal shock wave lithotripsy; endoscopy; botulinum toxin A treatment; abortion; chronic pain treatment; preceding use of psychopharmaceuticals; contraindication to lorazepam.

Intervention: Lorazepam (1 to 1.5 mg) intravenously vs. NaCl 0.9% as a premedication prior to surgery.

Main outcome measure: Quality of Recovery-40 (QoR-40) score.

Secondary outcomes: State-Trait Anxiety Inventory (STAI-State/Trait); State-Trait Anger Scale (STAS-State/Trait); Multidimensional Fatigue Inventory (MFI); Hospital Anxiety and Depression Scale (HADS). Timing of evaluation: T0: preoperatively (all scales); T1: before discharge (STAI-State/Trait); T2: first postoperative working day (QoR-40); T3: 7th day after surgery (all scales). Robust regression analysis was applied. Statistical analyses were adjusted for the corresponding baseline value and sex.

Results: Four hundred patients were randomised; 398 patients were analysed. Postoperative mean QoR-40 scores were similar in both groups at T2 (174.5 vs. 176.4, P = 0.34) and T3 (172.8 vs.176.3, P = 0.38). Postoperative mean STAI-State/Trait scores decreased less in the group with lorazepam at T1 (32.3 vs. 29.3, P < 0.0001; 32.7 vs. 30.8, P = 0.0002). STAI-Trait and HADS-Anxiety decreased less in the group with lorazepam at T3 (31.1 vs. 30.0; P = 0.03, 3.3 vs. 2.5, P = 0.003). STAS-State increased in the group with lorazepam at T3 (10.8 vs. 10.3, P = 0.04).

Conclusion: In day-case surgery, lorazepam as a premedication did not improve quality of recovery. Furthermore, this premedication may delay the decrease in postoperative anxiety and aggression.

Trial registration: ClinicalTrials.gov identifier: NCT01441843.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aggression / drug effects
  • Ambulatory Surgical Procedures / methods*
  • Anti-Anxiety Agents / therapeutic use*
  • Anxiety / epidemiology
  • Anxiety / etiology
  • Anxiety / prevention & control*
  • Double-Blind Method
  • Female
  • Humans
  • Lorazepam / therapeutic use*
  • Male
  • Middle Aged
  • Postoperative Period
  • Premedication / methods
  • Psychiatric Status Rating Scales
  • Regression Analysis


  • Anti-Anxiety Agents
  • Lorazepam

Associated data

  • ClinicalTrials.gov/NCT01441843