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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

220 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-01

Study Completion Date

2026-01-10

Brief Summary

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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.

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Detailed Description

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Sentinel lymph node biopsy is a standard procedure in breast cancer surgery to assess lymphatic spread. Methylene blue is widely used as a dye for sentinel lymph node mapping due to its safety, practicality, and cost-effectiveness. However, recent studies have suggested that methylene blue may have systemic vasopressor effects, particularly when it enters the circulation, by inhibiting guanylate cyclase and blocking nitric oxide pathways. This mechanism has been utilized in the management of refractory hypotension in septic shock, but its intraoperative hemodynamic effects during breast surgery remain unclear.

This prospective observational study will be conducted at Dr. Abdurrahman Yurtaslan Training and Research Hospital, Department of Anesthesiology and Reanimation, between August 1, 2025, and February 1, 2026. The study population will consist of two distinct cohorts: the Methylene Blue Group and the Control Group. Adult patients (aged 18-70) scheduled for elective breast surgery (mastectomy, lumpectomy, or sentinel lymph node biopsy) will be included. The Methylene Blue Group will consist of patients who receive intradermal methylene blue for sentinel lymph node mapping, while the Control Group will consist of patients undergoing breast surgery where no methylene blue or other mapping dyes are administered. All patients will be informed and written consent will be obtained prior to surgery. The study is entirely observational, with no intervention or alteration in the standard clinical management of patients.

Demographic data (age, BMI, ASA score), comorbidities, anesthesia protocols, methylene blue dose and timing (for the study group), and intraoperative hemodynamic parameters (blood pressure, heart rate, oxygen saturation) will be recorded for all participants. The incidence of intraoperative hypotension (defined as MAP \<65 mmHg or a decrease of more than 20% from baseline) and the need for vasopressor support will be analyzed and compared between the two groups. Hemodynamic data will be collected at baseline (before anesthesia induction), immediately before methylene blue administration (or at a corresponding surgical time point for the control group), and at 5, 10, 15, 30, and 60 minutes after administration/reference point, as well as at the end of surgery.

The primary aim of this study is to assess and compare the impact of intradermal methylene blue on intraoperative hemodynamic stability against a control group in patients undergoing breast surgery under general anesthesia. By including a control group of patients who do not receive the dye, the study aims to isolate the specific hemodynamic effects of methylene blue from the general physiological changes associated with anesthesia and surgical stress. The results are expected to provide valuable information regarding the safety and potential vasopressor benefits of methylene blue in this context, helping anesthesia and surgical teams anticipate and manage possible hemodynamic changes during surgery. The findings may also contribute to the development of evidence-based protocols for the use of methylene blue in breast cancer surgery and guide future research in this area.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Methylene Blue

Intervention Type 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.

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.

Standard Surgical Care Without Dye

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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.

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes