Actively Recruiting
Effect of Dexmedetomidine on Microsurgery Reconstruction in Cancer Patient
Led by Dharmais National Cancer Center Hospital · Updated on 2025-06-15
60
Participants Needed
2
Research Sites
62 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effect of Dexmedetomidine on Microsurgery Reconstruction in Cancer Patient
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients aged 18 to 65 years diagnosed with cancer and scheduled for microsurgical flap reconstruction
- Patients within the age range of 18 to 65 years at enrollment
- Patients who provide written informed consent to participate in the study
You will not qualify if you...
- History of uncontrolled diabetes mellitus
- Diagnosis of chronic kidney disease
- Known liver failure
- Receiving corticosteroid therapy prior to surgery
- Uncontrolled hypertension
- History of chemotherapy or radiotherapy prior to surgery
- Diagnosis of preoperative sepsis
- Need for perioperative vasopressor support
- History of prior surgery in the same operative field
- Decline to participate in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Dharmais National Cancer Center Hospital
Jakarta, DKI Jakarta, Indonesia, 11420
Not Yet Recruiting
2
Dharmais National Cancer Center Hospital
Jakarta, DKI Jakarta, Indonesia, 11420
Actively Recruiting
Research Team
G
Gardian Lukman Hakim, Anestesiologist
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here