Clinical trial · Observational
Hemodynamic Effects of Intradermal Methylene Blue During Breast Surgery Under General Anesthesia
The Effect of Intradermal Methylene Blue Application on Hemodynamic Stability Under General Anesthesia in Breast Surgery: A Prospective Observational Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Surgery | — | UNRESOLVED | — |
| Hemodynamic Stability | — | UNRESOLVED | — |
| Intraoperative Hypotension | — | UNRESOLVED | — |
| Methylene Blue | — | UNRESOLVED | — |
| Sentinel Lymph Node Biopsy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Methylene Blue | Procedure | — | UNRESOLVED |
| Standard Surgical Care Without Dye | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Methylene Blue Group
- description
- Patients undergoing elective breast surgery who receive an intradermal injection of 5 mL of 1% methylene blue for sentinel lymph node mapping.
- interventionNames
- Procedure: Methylene Blue
- label
- Control Group
- description
- 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.
- interventionNames
- Other: Standard Surgical Care Without Dye
Primary outcomes (1)
- measure
- Comparison of Intraoperative Hemodynamic Stability Between Methylene Blue and Control Groups
- timeFrame
- From the induction of anesthesia until the end of the surgical procedure (approximately 1 to 3 hours per patient).
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDVeronesi 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
- BACKGROUNDKirov 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
- BACKGROUNDMemis 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