Dexmedetomidine for better microvascular flap recovery after cancer reconstruction

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

This trial will try giving dexmedetomidine during surgery to see if it improves early flap survival and microvascular health in adults having elective microsurgical reconstruction for cancer.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Dharmais National Cancer Center Hospital (other gov)
• Drugs / interventions: chemotherapy
• Locations: 2 sites (Jakarta, DKI Jakarta and 1 other locations)
• Trial ID: NCT06993740 on ClinicalTrials.gov

What this trial studies

This double-blinded randomized controlled trial will enroll 60 adult cancer patients undergoing elective microvascular reconstructive surgery and randomize them to receive either intravenous dexmedetomidine or saline during the operation. The primary outcome is clinical flap viability within 48 hours after surgery, measured by a standardized score using flap color, temperature, capillary refill, and tissue turgor, with secondary outcomes including biomarkers for glycocalyx degradation (syndecan-1), oxidative stress (SOD-1), inflammation (IL-6, IL-10), thrombosis (PAI-1), angiogenesis (VEGF), and microcirculatory imaging with Sidestream Dark Field devices. All infusions are prepared identically to maintain blinding, and perioperative care is standardized to limit confounding factors. The goal is to determine whether intraoperative dexmedetomidine can modulate endothelial and inflammatory pathways to reduce early flap compromise in this high-risk surgical population.

Who should consider this trial

Good fit: Adults aged 18–65 with cancer who are scheduled for elective microsurgical flap reconstruction and can provide informed consent and attend perioperative follow-up are the ideal candidates.

Not a fit: Patients with uncontrolled diabetes, chronic kidney or liver failure, recent chemotherapy or radiotherapy, perioperative vasopressor needs, preoperative sepsis, prior surgery in the same field, or current corticosteroid therapy are excluded and unlikely to receive benefit from participation.

Why it matters

Potential benefit: If successful, the intervention could reduce early flap failure and related reoperations by protecting microvascular function and reducing inflammation and thrombosis.

How similar studies have performed: Preclinical and perioperative studies have shown dexmedetomidine can protect the endothelium and reduce inflammation, but randomized data specifically demonstrating improved microvascular flap survival are limited.

Eligibility criteria

Inclusion Criteria:

1. Adult patients (aged 18-65 years) diagnosed with cancer who are scheduled to undergo microsurgical flap reconstruction.
2. Patients within the age range of 18 to 65 years at the time of enrollment.
3. Patients who provide written informed consent to participate in the study.

Exclusion Criteria:

1. Patients with a history of uncontrolled diabetes mellitus.
2. Patients diagnosed with chronic kidney disease.
3. Patients with known liver failure.
4. Patients receiving corticosteroid therapy prior to surgery.
5. Patients with uncontrolled hypertension.
6. Patients with a history of chemotherapy or radiotherapy prior to surgery.
7. Patients diagnosed with preoperative sepsis.
8. Patients requiring perioperative vasopressor support.
9. Patients with a history of prior surgery in the same operative field.
10. Patients who decline to participate in the study.

Where this trial is running

Jakarta, DKI Jakarta and 1 other locations

• Dharmais National Cancer Center Hospital — Jakarta, DKI Jakarta, Indonesia (NOT_YET_RECRUITING)
• Dharmais National Cancer Center Hospital — Jakarta, DKI Jakarta, Indonesia (RECRUITING)

Study contacts

• Study coordinator: Gardian Lukman Hakim, Anestesiologist

Conditions: Flap Monitoring, Inflammation, Thrombosis, Oxidative Stress, Glycocalyx, Anesthesia, Surgery, Flap Ischemia