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Randomized Controlled Trial
. 2022 Mar;47(2):123-130.
doi: 10.30476/ijms.2021.86960.1701.

Effect of Preoperative Administration of Oral Melatonin on Pneumatic Tourniquet-Induced Ischemia-Reperfusion Injury in Orthopedic Surgery of Lower Extremities: A Randomized Clinical Trial

Reza Jouybar  1 , Saeed Khademi  2 , Sima Razmjooie  2 , Neda Bagheri  3
Affiliations
Randomized Controlled Trial

Effect of Preoperative Administration of Oral Melatonin on Pneumatic Tourniquet-Induced Ischemia-Reperfusion Injury in Orthopedic Surgery of Lower Extremities: A Randomized Clinical Trial

Reza Jouybar et al. Iran J Med Sci. 2022 Mar.

Abstract

Background: 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.

Methods: 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.

Results: 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).

Conclusion: 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.

Trial registration number: IRCT20141009019470N87.

Keywords: Malondialdehyde; Melatonin; Reperfusion injury; Superoxide dismutase.

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Figures

Figure 1
Figure 1
The CONSORT diagram shows the allocation process throughout the trial.
Figure 2
Figure 2
Changes in the mean arterial pressure (MAP), malondialdehyde (MDA), superoxide dismutase (SOD), and the score of Ramsey sedation scale (RSS) over time between the melatonin and placebo groups.
See this image and copyright information in PMC

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