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.
Adult patients (aged 18-65 years) diagnosed with cancer who are scheduled to undergo microsurgical flap reconstruction.
Patients within the age range of 18 to 65 years at the time of enrollment.
Patients who provide written informed consent to participate in the study.
Patients with a history of uncontrolled diabetes mellitus.
Patients diagnosed with chronic kidney disease.
Patients with known liver failure.
Patients receiving corticosteroid therapy prior to surgery.
Parallel
NaCl 0,9%
DrugNaCl 0.9% continuous intravenous infusion during microsurgical reconstruction surgery in cancer patients, started after anesthesia induction and maintained intraoperatively and up to 48 hours postoperatively.
Dexmedetomidine
DrugDexmedetomidine continuous intravenous infusion during microsurgical reconstruction surgery in cancer patients, started after anesthesia induction and maintained intraoperatively and up to 48 hours postoperatively, titrated to maintain target sedation and hemodynamic stability.
Flap Viability Score
Clinical evaluation of flap viability using a standardized scoring system based on four parameters: flap color, surface temperature, capillary refill time, and tissue turgor. Each parameter is scored individually and combined into a composite viability score. The total score reflects the degree of perfusion and tissue viability at 48 hours after microsurgical reconstruction.
Tissue Syndecan-1 Expression
Quantitative evaluation of syndecan-1 expression in flap tissue using immunohistochemistry (IHC) to assess endothelial glycocalyx integrity. Image analysis software will be used for objective quantification.
Tissue Superoxide Dismutase 1 (SOD1) Expression
Quantitative analysis of SOD1 expression in flap tissue using IHC, serving as a marker of oxidative stress response. Expression will be measured using image-based digital quantification.
Interleukin-6 (IL-6) Level
Measurement of systemic IL-6 concentrations using Electrochemiluminescence Immunoassay (ECLIA) as an indicator of systemic inflammatory response.
Interleukin-10 (IL-10) Level
Quantification of serum IL-10 levels using Enzyme-Linked Immunosorbent Assay (ELISA), to evaluate anti-inflammatory cytokine response.
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