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

BACKGROUNDIn day-case surgery, the effects of the anxiolytic lorazepam as premedication on the quality of postoperative recovery are unknown.OBJECTIVETo evaluate whether lorazepam as a premedication beneficially affects quality of recovery (primary outcome) and psychological manifestations (secondary outcome) after day-case surgery.DESIGNA randomised, double-blind, placebo-controlled clinical trial.SETTINGSingle tertiary centre.PATIENTSInclusion 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.INTERVENTIONLorazepam (1 to 1.5mg) intravenously vs. NaCl 0.9% as a premedication prior to surgery.MAIN OUTCOME MEASUREQuality 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.RESULTSFour 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).CONCLUSIONIn 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 REGISTRATIONClinicalTrials.gov identifier: NCT01441843.