RecruitingNot ApplicableNCT06993740

Effect of Dexmedetomidine on Microsurgery Reconstruction in Cancer Patient

The Effect of Dexmedetomidine Administration on the Success of Reconstructive Microsurgery in Cancer Patients: A Study of Glycocalyx Integrity, Inflammatory Response, Thrombosis, Angiogenesis, Oxidative Stress, and Tissue Microcirculation

Sponsor

Dharmais National Cancer Center Hospital

Enrollment

60 participants

Start Date

Jun 10, 2025

Study Type

INTERVENTIONAL

Conditions

Surgery Anesthesia Thrombosis Inflammation Oxidative Stress Flap Monitoring Glycocalyx Flap Ischemia Flap Necrosis Flap Failure Risk Factors Microsurgery

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria3

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 Criteria10

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.
Patients diagnosed with preoperative sepsis.
Patients requiring perioperative vasopressor support.
Patients with a history of prior surgery in the same operative field.
Patients who decline to participate in the study.

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Interventions

DRUGNaCl 0,9%

NaCl 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.

DRUGDexmedetomidine

Dexmedetomidine 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.