Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID06993740

The Effect of Dexmedetomidine on the Success of Reconstructive Microsurgery in Cancer Patients Evaluating Glycocalyx Integrity, Inflammation, Thrombosis, Angiogenesis, Oxidative Stress, and Tissue Microcirculation

Led by Dharmais National Cancer Center Hospital · Updated on 2025-06-15

60

Participants Needed

2

Research Sites

12 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the impact of intraoperative dexmedetomidine administration on early flap viability and microvascular health in adult cancer patients undergoing elective microvascular reconstructive surgery. This double-blinded randomized controlled trial aims to determine if dexmedetomidine can improve early surgical outcomes by influencing inflammation, endothelial function, thrombosis, and tissue perfusion, which are critical for flap success. Participants will be randomly assigned to receive either intravenous dexmedetomidine or a placebo (normal saline) starting after anesthesia induction and continuing for up to 48 hours postoperatively. Dexmedetomidine will be given as a loading dose followed by a continuous infusion titrated to maintain sedation and stable hemodynamics. Both groups will undergo general anesthesia with fentanyl and propofol, and the infusions will be prepared identically to ensure blinding. During the study, researchers will assess flap viability clinically within 48 hours after surgery using a scoring system based on flap color, temperature, capillary refill, and tissue firmness. They will also measure biomarkers related to glycocalyx degradation, oxidative stress, inflammation, thrombosis, and angiogenesis from blood and tissue samples. Additionally, microcirculation will be evaluated with Sidestream Dark Field imaging at multiple time points. The study intends to provide insights into dexmedetomidine's role in improving microvascular reconstructive surgery outcomes in cancer patients.

CONDITIONS

Brief Title

Effect of Dexmedetomidine on Microsurgery Reconstruction in Cancer Patient

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients aged 18 to 65 years
  • Diagnosed with cancer and scheduled for microsurgical flap reconstruction
  • Provide written informed consent to participate
Not Eligible

You will not qualify if you...

  • History of uncontrolled diabetes mellitus
  • Diagnosis of chronic kidney disease
  • Known liver failure
  • Receiving corticosteroid therapy before surgery
  • Uncontrolled hypertension
  • History of chemotherapy or radiotherapy before surgery
  • Preoperative sepsis
  • Need for perioperative vasopressor support
  • History of prior surgery in the same operative field
  • Decline to participate in the study

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Surgery day plus 48 hours postoperatively

Participants undergo microvascular reconstructive surgery under general anesthesia and receive a continuous intravenous infusion of either dexmedetomidine or placebo starting after anesthesia induction and continuing intraoperatively and up to 48 hours postoperatively to support flap viability and recovery.

1 surgery day visit and monitoring during 48 hours postoperatively

Follow-up

Duration - Up to 48 hours postoperatively

Participants have postoperative assessments including flap viability scoring and tissue microcirculation imaging to evaluate surgical outcomes and biological markers related to inflammation, thrombosis, and tissue perfusion.

3 visits within 48 hours post-surgery (immediate, 12 hours, and 48 hours postoperative)

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

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Research Team

G

Gardian Lukman Hakim, Anestesiologist

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Sidestream dark field images of the microcirculation: intra-observer reliability and correlation between two semi-quantitative methods for determining flow.

Sandra M Petersen, Gorm Greisen, Simon Hyttel-Sorensen...

https://pubmed.ncbi.nlm.nih.gov/24885423

Endothelial inflammatory and thrombogenic expression changes in microvascular anastomoses - An immunohistochemical analysis.

Raimund H M Preidl, Silvy Reuss, Friedrich W Neukam...

https://pubmed.ncbi.nlm.nih.gov/33608202

Effect of dexmedetomidine on blood coagulation in patients undergoing radical gastrectomy under general anesthesia: A prospective, randomized controlled clinical trial.

Zheng Chen, Dong-Hua Shao, Zu-Min Mao...

https://pubmed.ncbi.nlm.nih.gov/29979445

Dexmedetomidine May Reduce IL-6 Level and the Risk of Postoperative Cognitive Dysfunction in Patients After Surgery: A Meta-Analysis.

Daoyun Lei, Yeqin Sha, Shuang Wen...

https://pubmed.ncbi.nlm.nih.gov/32076394