The effect of melatonin on prevention of postoperative delirium after lower limb fracture surgery in elderly patients: a randomized double blind clinical trial.

IF 1.4 Q3 EMERGENCY MEDICINE International Journal of Burns and Trauma Pub Date : 2022-08-15 eCollection Date: 2022-01-01
Mohammad Reza Fazel, Saba Mofidian, Mehrdad Mahdian, Hossein Akbari, Mohammad Reza Razavizadeh
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Abstract

Background: Postoperative delirium is a common complication with a high morbidity rate. This study was designed to consider the effectiveness of melatonin in prevention and treatment of postoperative delirium.

Methods: Seventy-two patients aged >60 years old with Abbreviated Mental Test (AMT) >8 scheduled for orthopedic surgery under spinal anesthesia, were randomly distributed equally to melatonin or placebo groups. In the melatonin group, the patients were given 5 mg melatonin capsules orally the night before surgery, the night of the operation, and two nights after the surgical operation at 9 pm. Likewise, in the placebo group, the patients received placebo in the same times. For diagnosis of postoperative delirium, the AMT test was used before the operation and three days after that. The Generalized estimating equations model (GEE) with logit link to Multivariate analysis was used in the study and P<0.05 was considered statistically significant.

Results: In total, 72 patients completed the study. Thirty-three patients (45.8%) were male with a mean (SD) age 71.4 (3.6) years. On the first day after the surgery, the incidence of delirium was significantly lower in the melatonin group compared to the placebo group (22.2% vs. 44.4%, P=0.046). On the second and third days after the surgery, the level of delirium in the melatonin group was also significantly lower than that in the placebo one. The GEE model showed a significant interaction between time and treatment groups.

Conclusion: The findings of the study showed that melatonin prevented delirium after the orthopedic surgeries in the elderly patients and could be useful for the patients as such.

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褪黑素对老年下肢骨折术后谵妄的预防作用:随机双盲临床试验
背景:术后谵妄是一种常见的并发症,发病率很高。本研究旨在探讨褪黑素在预防和治疗术后谵妄中的有效性。方法:72例年龄>60岁、AMT >8分、拟行脊柱麻醉下骨科手术的患者,随机分为褪黑素组和安慰剂组。褪黑素组患者术前一晚、术中一晚、术后两晚晚9时口服褪黑素胶囊5 mg。同样,在安慰剂组中,患者在相同的时间接受安慰剂。对于术后谵妄的诊断,术前和术后3天分别进行AMT试验。研究采用logit链接多元分析的广义估计方程模型(GEE)。结果:总共有72例患者完成了研究。33例(45.8%)为男性,平均(SD)年龄71.4(3.6)岁。术后第一天,与安慰剂组相比,褪黑素组谵妄发生率显著降低(22.2% vs 44.4%, P=0.046)。在手术后的第二和第三天,褪黑素组的谵妄水平也明显低于安慰剂组。GEE模型显示时间组和治疗组之间有显著的相互作用。结论:褪黑素对老年骨科术后谵妄患者有预防作用,对老年骨科术后谵妄患者有一定的临床应用价值。
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