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Hemodynamic Effects of Intradermal Methylene Blue During Breast Surgery Under General Anesthesia

NCT07040540 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 220

Last updated 2026-04-30

No results posted yet for this study

Summary

This prospective observational study aims to evaluate the effects of intradermal methylene blue injection on intraoperative hemodynamic stability in patients undergoing breast surgery under general anesthesia. While methylene blue is commonly used for sentinel lymph node mapping, its potential systemic vasopressor effects remain unclear. To provide a comprehensive analysis, the study will compare patients receiving methylene blue with a control group of patients undergoing similar breast procedures without the use of any dye. Hemodynamic parameters such as blood pressure, heart rate, and oxygen saturation will be recorded and compared between the two groups to determine the specific impact of methylene blue on the incidence of intraoperative hypotension and the need for vasopressor support.

Conditions

  • Breast Cancer
  • Breast Surgery
  • Sentinel Lymph Node Biopsy
  • Methylene Blue
  • Hemodynamic Stability
  • Intraoperative Hypotension

Interventions

PROCEDURE

Methylene Blue

Intradermal injection of 5 mL of 1% methylene blue solution administered into the breast tissue for sentinel lymph node mapping during breast cancer surgery. The dye is used to identify the first lymph nodes draining from the tumor site.

OTHER

Standard Surgical Care Without Dye

Patients undergo standard breast surgery (mastectomy or lumpectomy) without administration of methylene blue or any other lymphatic mapping agent. All other perioperative care follows institutional standard protocols.

Sponsors & Collaborators

  • Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

    lead OTHER

Principal Investigators

  • Mustafa Kemal Şahin · Dr. Abdurrahman Yurtaslan Training and Research Hospital, University of Health Sciences

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2025-11-01
Completion
2026-01-10

Countries

  • Turkey (Türkiye)

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07040540 on ClinicalTrials.gov