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

NCT07040540 | Completed

• 1 other identifier: 2025-06/85
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Comparison of Intraoperative Hemodynamic Stability Between Methylene Blue and Control Groups

  The primary outcome is to compare the incidence of intraoperative hypotension (defined as a Mean Arterial Pressure \<65 mmHg or a \>20% decrease from baseline) and the total requirement for vasopressor administration (e.g., ephedrine, phenylephrine) between patients receiving intradermal methylene blue and the control group.

  From the induction of anesthesia until the end of the surgical procedure (approximately 1 to 3 hours per patient).

Secondary Outcomes (1)

• Mean Arterial Pressure (MAP) and Heart Rate (HR) Trends

  At specific intervals: Baseline, pre-injection, and 5, 10, 15, 30, 60 minutes after methylene blue administration or the corresponding surgical reference point.

Study Arms (2)

Methylene Blue Group

Patients undergoing elective breast surgery who receive an intradermal injection of 5 mL of 1% methylene blue for sentinel lymph node mapping.

Procedure: Methylene Blue

Control Group

Patients undergoing elective breast surgery (mastectomy, lumpectomy, etc.) who do not receive methylene blue or any other dye injection, serving as a baseline for hemodynamic stability under general anesthesia.

Other: Standard Surgical Care Without Dye

Interventions

Methylene Blue PROCEDURE

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.

Methylene Blue Group

Standard Surgical Care Without Dye OTHER

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.

Control Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult female patients, aged 18 to 70 years, who are scheduled for elective breast surgery at Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital. This population includes two distinct cohorts: (1) patients undergoing procedures that require sentinel lymph node mapping using intradermal methylene blue injection (such as breast-conserving surgery or mastectomy with SLNB), and (2) patients undergoing breast surgery (such as mastectomy or lumpectomy) where no methylene blue or other mapping dyes are administered, serving as the control group. All participants are selected from patients receiving general anesthesia and managed according to standard clinical protocols.

You may qualify if:

• Female patients aged 18 to 70 years. Scheduled for elective breast surgery (mastectomy, lumpectomy, or sentinel lymph node biopsy).
• For the study group: Planned use of intradermal methylene blue. For the control group: Breast surgery without the use of methylene blue. Provided written informed consent.

You may not qualify if:

• Known allergy or hypersensitivity to methylene blue or other dyes Presence of severe cardiovascular disease Pregnancy Incomplete or missing data records

Sponsors & Collaborators

• Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital: lead

Study Sites (1)

Dr. Abdurrahman Yurtaslan Ankara Oncology Education and Research Hospital Clinic of Anesthesiology and Rea

Ankara, Yenimahalle, 06200, Turkey (Türkiye)

Location

Related Publications (3)

• Veronesi U, Paganelli G, Viale G, Galimberti V, Luini A, Zurrida S, Robertson C, Sacchini V, Veronesi P, Orvieto E, De Cicco C, Intra M, Tosi G, Scarpa D. Sentinel lymph node biopsy and axillary dissection in breast cancer: results in a large series. J Natl Cancer Inst. 1999 Feb 17;91(4):368-73. doi: 10.1093/jnci/91.4.368.

  PMID: 10050871 BACKGROUND

• Kirov MY, Evgenov OV, Evgenov NV, Egorina EM, Sovershaev MA, Sveinbjornsson B, Nedashkovsky EV, Bjertnaes LJ. Infusion of methylene blue in human septic shock: a pilot, randomized, controlled study. Crit Care Med. 2001 Oct;29(10):1860-7. doi: 10.1097/00003246-200110000-00002.

  PMID: 11588440 BACKGROUND

• Memis D, Karamanlioglu B, Yuksel M, Gemlik I, Pamukcu Z. The influence of methylene blue infusion on cytokine levels during severe sepsis. Anaesth Intensive Care. 2002 Dec;30(6):755-62. doi: 10.1177/0310057X0203000606.

  PMID: 12500513 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Methylene Blue; Coloring Agents

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phenothiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Specialty Uses of Chemicals; Chemical Actions and Uses

Study Officials

• Mustafa Kemal Şahin

  Dr. Abdurrahman Yurtaslan Training and Research Hospital, University of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: June 27, 2025
• Study Start: July 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: January 10, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)