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Trial · Observational

CompletedPhase not statedRegistry data

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

NCTNCT07040540 (opens ClinicalTrials.gov in a new tab)Other id2025-06/85
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase not stated
Enrollment
220 participants (actual)
Sponsor
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital · Other
Design
Not stated
Countries
1 country

Turkey (Türkiye)

Start
1 Jul 2025
Primary completion
1 Nov 2025
Completion
10 Jan 2026
First posted
27 Jun 2025
Last update posted
30 Apr 2026
Conditions
Breast Cancer · Breast Surgery · Sentinel Lymph Node Biopsy · Methylene Blue · Hemodynamic Stability · Intraoperative Hypotension

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202520262027
  1. Ph –

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

    NCT07040540

    1 Jul 2025 to 10 Jan 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Methylene BlueProcedure
  • Standard Surgical Care Without DyeOther

Arms2

  • Other

    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.

  • Other

    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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Comparison of Intraoperative Hemodynamic Stability Between Methylene Blue and Control Groups

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

    Registry description

    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.

Secondary outcomes(1)

  1. Mean Arterial Pressure (MAP) and Heart Rate (HR) Trends

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

    Registry description

    Comparison of the mean values of MAP and HR at specific intervals (baseline, pre-injection, and 5, 10, 15, 30, 60 minutes post-injection/reference point) between the two groups to identify the systemic vasopressor effect of methylene blue.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2001

16 results

Infusion of methylene blue in human septic shock: a pilot, randomized, controlled study.

Kirov et al. 2001Critical care medicinecited by 173

PMID 11588440DOI 10.1097/00003246-200110000-00002PUB-11588440

Full text at the publisher16 results
Publisher pageSee results (16)

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 70 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

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