Effect of Dexmedetomidine on Microsurgery Reconstruction in Cancer Patient (NCT06993740) | Clinical Trial Compass
RecruitingNot Applicable
Effect of Dexmedetomidine on Microsurgery Reconstruction in Cancer Patient
Indonesia60 participantsStarted 2025-06-10
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
✕. Patients with uncontrolled hypertension.
✕. Patients with a history of chemotherapy or radiotherapy prior to surgery.