Effect of Dexmedetomidine on Microsurgery Reconstruction in Cancer Patient

Summary

This double-blinded randomized controlled trial aims to investigate the effect of intraoperative dexmedetomidine administration on early flap viability and microvascular integrity in cancer patients undergoing elective microvascular reconstructive surgery. The primary outcome is clinical flap viability within 48 hours postoperatively, assessed using a standardized scoring system based on flap color, temperature, capillary refill time, and tissue turgor. Secondary outcomes include the evaluation of biomarkers related to endothelial glycocalyx degradation (syndecan-1), oxidative stress (SOD-1), inflammation (IL-6, IL-10), thrombosis (PAI-1), and angiogenesis (VEGF), as well as microcirculatory assessment using Sidestream Dark Field (SDF) imaging. The study is designed to determine whether dexmedetomidine improves early surgical outcomes by modulating pathophysiological processes involved in microvascular flap success.

Timeline

Start

2025-06-10

Primary completion

2026-05-26

Completion

2026-08-22

Publications

• Background Petersen SM, Greisen G, Hyttel-Sorensen S, Hahn GH. Sidestream dark field images of the microcirculation: intra-observer reliability and correlation between two semi-quantitative methods for determining flow. BMC Med Imaging. 2014 May 6;14:14. doi: 10.1186/1471-2342-14-14.
• Background Atmodiwirjo P, Priambodo PS, Dilogo IH. Pengaruh Titrasi Indocyanine Green terhadap Intensitas Fluoresensi pada Perfusi Flap Bebas dalam Menunjang Tindakan Bedah Mikro Rekonstruksi: Tinjauan terhadap Suhu, TcPCO2, TcPO2, Ekspresi HIF-1α, dan Histopatologi Flap. Universitas Indonesia; 2024.
• Background Preidl RHM, Reuss S, Neukam FW, Kesting M, Wehrhan F. Endothelial inflammatory and thrombogenic expression changes in microvascular anastomoses - An immunohistochemical analysis. J Craniomaxillofac Surg. 2021 May;49(5):422-429. doi: 10.1016/j.jcms.2021.02.006. Epub 2021 Feb 12.
• Background Chen Z, Shao DH, Mao ZM, Shi LL, Ma XD, Zhang DP. Effect of dexmedetomidine on blood coagulation in patients undergoing radical gastrectomy under general anesthesia: A prospective, randomized controlled clinical trial. Medicine (Baltimore). 2018 Jul;97(27):e11444. doi: 10.1097/MD.0000000000011444.
• Background Fang M, He J, Ma X, Li W, Lin D. Protective effects of dexmedetomidine on the survival of random flaps. Biomed Pharmacother. 2020 Aug;128:110261. doi: 10.1016/j.biopha.2020.110261. Epub 2020 May 20.
• Background Wijanarko B, Airlangga PS, Fitriati M, Sumartono C, Kriswidyatomo P, Lestari P. Effect of dexmedetomidine administration on malondialdehyde levels in lower extremity surgery using tourniquets. Bali Medical Journal. 2023 May 6;12(2):1459-65.
• Background Li B, Li Y, Tian S, Wang H, Wu H, Zhang A, Gao C. Anti-inflammatory Effects of Perioperative Dexmedetomidine Administered as an Adjunct to General Anesthesia: A Meta-analysis. Sci Rep. 2015 Jul 21;5:12342. doi: 10.1038/srep12342.
• Background Hsu TC, Lin CH, Sun FJ, Chen MJ. Postoperative Serum Levels of Interleukin-6 are Affected by Age in Patients with Colorectal Cancer. Int J Gerontol. 2017 Jun;11(2):75-9.
• Background Finke JC, Yang J, Bredell M, Fritschen U von, Glocker MO. Plasma Cytokine and Growth Factor Profiling during Free Flap Transplantation. In: Issues in Flap Surgery. InTech; 2018.
• Background Lei D, Sha Y, Wen S, Xie S, Liu L, Han C. Dexmedetomidine May Reduce IL-6 Level and the Risk of Postoperative Cognitive Dysfunction in Patients After Surgery: A Meta-Analysis. Dose Response. 2020 Feb 5;18(1):1559325820902345. doi: 10.1177/1559325820902345. eCollection 2020 Jan-Mar.
• Background Yuki K. The immunomodulatory mechanism of dexmedetomidine. Int Immunopharmacol. 2021 Aug;97:107709. doi: 10.1016/j.intimp.2021.107709. Epub 2021 Apr 29.
• Background Abassi Z, Armaly Z, Heyman SN. Glycocalyx Degradation in Ischemia-Reperfusion Injury. Am J Pathol. 2020 Apr;190(4):752-767. doi: 10.1016/j.ajpath.2019.08.019. Epub 2020 Feb 6.
• Background Pillinger NL, Kam P. Endothelial glycocalyx: basic science and clinical implications. Anaesth Intensive Care. 2017 May;45(3):295-307. doi: 10.1177/0310057X1704500305.
• Background Pang CY, Neligan PC. Flap Pathophysiology and Pharmacology. In: Gurtner GC, Neligan PC, editors. Plastic Surgery, Volume 1: Principles. Fourth Ed. Canada: Elsevier Inc.; 2018. p. 433-443.e7.
• Background Sigaux N, Philouze P, Boucher F, Jacquemart M, Frobert P, Breton P. Efficacy of the postoperative management after microsurgical free tissue transfer. J Stomatol Oral Maxillofac Surg. 2017 Jun;118(3):173-177. doi: 10.1016/j.jormas.2017.03.007. Epub 2017 Apr 5.
• Background Han M, Ochoa E, Zhu B, Park AM, Heaton CM, Seth R, Knott PD. Risk Factors for and Cost Implications of Free Flap Take-backs: A Single Institution Review. Laryngoscope. 2021 Jun;131(6):E1821-E1829. doi: 10.1002/lary.29382. Epub 2021 Jan 13.
• Background Pu LLQ, Song P. Reoperative Microsurgical Free Flap Surgery: Lessons Learned. Ann Plast Surg. 2023 May 1;90(5S Suppl 2):S187-S194. doi: 10.1097/SAP.0000000000003370. Epub 2023 Jan 18.
• Background Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
• Background Riskesdas. Hasil Utama Riskesdas 2018. Kementrian Kesehatan Republik Indonesia. 2018.

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