Shiraz Anesthesiology and Critical Research Center, Department of Anesthesiology, Shiraz University of Medical Sciences, Shiraz, Iran.
Anesthesiology and Critical Care Research Center, Department of Anesthesiology, Shiraz University of Medical Sciences, Shiraz, Iran.
Iran J Med Sci. 2022 Mar;47(2):123-130. doi: 10.30476/ijms.2021.86960.1701.
Ischemic reperfusion injury (IRI) causes cellular damage and dysfunction. The present study aimed to evaluate the effect of melatonin on pneumatic tourniquet-induced IRI in orthopedic surgery of the lower extremities.
A randomized clinical trial was conducted at Chamran Hospital, Shiraz University of Medical Sciences (Shiraz, Iran), from September to November 2019. The target population was patients scheduled for elective orthopedic surgery of the lower extremities. A total of 67 patients were randomly divided into two groups, placebo (n=34) and melatonin (n=33). The groups received 10 mg melatonin or placebo the night before surgery and two hours before surgery. Primary outcome variables were the serum levels of superoxide dismutase (SOD) and malondialdehyde (MDA). Hemodynamic parameters, sedation score, and drug side effects were also evaluated. Data were analyzed using SPSS version 21.0 software. P<0.05 was considered statistically significant.
In the analysis phase, due to loss to follow-up (n=26), 41 patients divided into two groups of melatonin (n=20) and placebo (n=21) were evaluated. There was no significant difference in demographic data, duration of surgery (P=0.929), and tourniquet time (P=0.496) between the groups. The serum levels of SOD and MDA were not significantly different between the groups (P=0.866 and P=0.422, respectively), nor were the incidence of postoperative nausea (P=0.588) and patients' satisfaction (P=0.088). However, the postoperative sedation score and vomiting between the groups were significantly different (P<0.001).
Administration of 10 mg melatonin provided effective sedation, but had no significant effect on the serum levels of SOD and MDA, nor on pneumatic tourniquet-induced IRI in orthopedic surgery of the lower limbs.
IRCT20141009019470N87.
缺血再灌注损伤（IRI）会导致细胞损伤和功能障碍。本研究旨在评估褪黑素对下肢骨科手术中气压止血带引起的 IRI 的影响。
2019 年 9 月至 11 月，在伊朗 Shiraz 大学 Chamran 医院进行了一项随机临床试验。研究对象为计划接受下肢择期骨科手术的患者。共有 67 名患者被随机分为两组，安慰剂组（n=34）和褪黑素组（n=33）。两组患者均于术前一晚和术前两小时分别接受 10mg 褪黑素或安慰剂治疗。主要观察指标为血清超氧化物歧化酶（SOD）和丙二醛（MDA）水平。还评估了血流动力学参数、镇静评分和药物副作用。数据采用 SPSS 21.0 软件进行分析。P<0.05 为差异有统计学意义。
在分析阶段，由于失访（n=26），41 名患者分为褪黑素组（n=20）和安慰剂组（n=21）进行评估。两组患者的人口统计学数据、手术持续时间（P=0.929）和止血带时间（P=0.496）无显著差异。两组患者血清 SOD 和 MDA 水平无显著差异（P=0.866 和 P=0.422），术后恶心发生率（P=0.588）和患者满意度（P=0.088）也无显著差异。但两组患者术后镇静评分和呕吐发生率存在显著差异（P<0.001）。
给予 10mg 褪黑素可产生有效镇静作用，但对 SOD 和 MDA 血清水平以及下肢骨科手术中气压止血带引起的 IRI 无显著影响。
IRCT20141009019470N87。
