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
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Indonesia
Dharmais National Cancer Center Hospital
RECRUITING
Jakarta
Dharmais National Cancer Center Hospital
NOT_YET_RECRUITING
Jakarta
Contact Information
Primary
Gardian Lukman Hakim, Anestesiologist
gardian.hakim@gmail.com
81218088113
Time Frame
Start Date:2025-06-10
Estimated Completion Date:2026-08-22
Participants
Target number of participants:60
Treatments
Placebo_comparator: Placebo Group
Participants in this arm will receive a continuous intravenous infusion of placebo (normal saline) administered in the same manner and duration as the dexmedetomidine group-starting after anesthesia induction and continuing for up to 48 hours postoperatively. This control infusion allows comparison of clinical and biochemical outcomes without the influence of dexmedetomidine.
Active_comparator: Dexmedetomidine Group
Participants assigned to this arm will receive a continuous intravenous infusion of dexmedetomidine starting after anesthesia induction and maintained throughout the surgical procedure as well as for up to 48 hours postoperatively. The infusion dose will be titrated to achieve target sedation levels while maintaining stable hemodynamics. This extended administration aims to investigate the effects of dexmedetomidine on endothelial glycocalyx preservation, inflammation modulation, thrombosis prevention, angiogenesis promotion, oxidative stress reduction, and improvement of tissue microcirculation during both intraoperative and early postoperative periods.