The efficacy of melatonin as a preoperative anxiolytic in real-world setting: a randomized controlled trial.

Abstract

Background: Preoperative anxiety is linked to various adverse effects on anesthesia, intraoperative vital signs, and postoperative outcomes. Despite its widespread impact, managing preoperative anxiety is not consistently implemented, partly due to concerns over the efficacy and side effects of anxiolytic drugs. Previous clinical trials on the anxiolytic effect of melatonin showed conflicting results regarding its effect. Furthermore, they involved placing the patients in settings that deviate of real-world clinical practice.

Objective: We sought to assess the efficacy of melatonin as a preoperative anxiolytic in real-world settings.

Methods: This is a triple-blinded, randomized, controlled clinical trial that enrolled 87 patients aged 18 to 65 planned for elective surgery under general anesthesia. They were divided into three groups to receive melatonin, diazepam, or a placebo and were placed in the same waiting rooms as other non-enrolled patients. Preoperative anxiety was assessed at baseline and one-hour post-treatment using the Visual Analog Scale (VAS) and Amsterdam Preoperative Anxiety and Information Scale (APAIS). Secondary outcomes included changes in orientation and sedation levels.

Results: Of the 87 enrolled participants, 76 completed the second assessment. The median age of the participants was 38 years (IQR = 18.5), and 50.6% were females. Our study showed no significant effect of melatonin on preoperative anxiety, sedation, or orientation compared to diazepam or placebo.

Conclusion: Our study highlights the need for incorporating other factors in future clinical trials on preoperative anxiety to better translate the results into a real-world setting.

Clinical trial registration number: NCT06103188.