Clinical Trial

Effect of Dexmedetomidine on Microsurgery Reconstruction in Cancer Patient

Study acronym: DEXFLAP
Completed
View on ClinicalTrials.gov →
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.
Protocol Amendment History 3 changes
critical Trial completed 2026-08-01
notable Primary completion moved earlier: 2026-05-26 -> 2026-03-06 2026-08-01
minor Completion moved earlier: 2026-08-22 -> 2026-03-08 2026-08-01
Trial Details
NCT Number NCT06993740
Lead Sponsor Dharmais National Cancer Center Hospital
Conditions Flap Monitoring, Inflammation, Thrombosis, Oxidative Stress, Glycocalyx, Anesthesia, Surgery, Flap Ischemia +3 more
Enrollment 60 participants
Start Date 2025-06-10
Primary Completion 2026-03-06 (estimated)
Study Completion 2026-03-08 (estimated)
Updated on ClinicalTrials.gov 2026-07-31