Breast CancerNCT07040540
Hemodynamic Effects of Intradermal Methylene Blue During Breast Surgery Under General Anesthesia
An observational study of Breast Cancer and Breast Surgery, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Breast Surgery, Sentinel Lymph Node Biopsy
- What is being tested?
- Methylene Blue and Standard Surgical Care Without Dye
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 220 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2025to 10 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Known allergy or hypersensitivity to methylene blue or other dyes Presence of severe cardiovascular disease Pregnancy Incomplete or missing data records
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dr. Abdurrahman Yurtaslan Ankara Oncology Education and Research Hospital Clinic of Anesthesiology and Rea
Ankara, Yenimahalle, 06200
About this study
Official title: The Effect of Intradermal Methylene Blue Application on Hemodynamic Stability Under General Anesthesia in Breast Surgery: A Prospective Observational Study
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.
Read the detailed description
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
- Breast Cancer, Breast Surgery, Sentinel Lymph Node Biopsy, Methylene Blue, Hemodynamic Stability, Intraoperative Hypotension
- Being tested
- Methylene Blue, Standard Surgical Care Without Dye
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylene BlueProcedure or surgery
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.
Standard Surgical Care Without DyeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard Surgical Care Without Dye |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: At specific intervals: Baseline, pre-injection, and 5, 10, 15, 30, 60 minutes after methylene blue administration or the corresponding surgical reference point.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start1 Jul 2025
- Primary completion1 Nov 2025
- Study completion10 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Kemal ŞAHİN, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
- Investigators
- Mustafa Kemal Şahin, Principal investigator, Dr. Abdurrahman Yurtaslan Training and Research Hospital, University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07040540
- Sponsor's protocol ID
- 2025-06/85
- Status last verified
- Apr 2026
- First submitted
- 19 Jun 2025
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 10050871Kirov 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.
PubMed 11588440Memis 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.
PubMed 12500513
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intradermal Methylene Blue Application on Hemodynamic Stability Under General Anesthesia in Breast Surgery: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07040540
- Acronym / sponsor ID
- 2025-06/85
- Conditions
- Breast Cancer, Breast Surgery, Sentinel Lymph Node Biopsy, Methylene Blue, Hemodynamic Stability, Intraoperative Hypotension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 10 Jan 2026 (actual)
- First posted
- 27 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methylene Blue Group | – | Procedure: Methylene BluePatients undergoing elective breast surgery who receive an intradermal injection of 5 mL of 1% methylene blue for sentinel lymph node mapping. |
| Control Group | – | Other: Standard Surgical Care Without DyePatients 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Known allergy or hypersensitivity to methylene blue or other dyes Presence of severe cardiovascular disease Pregnancy Incomplete or missing data records
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methylene BlueIntradermal 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. | Procedure or surgery | Methylene Blue Group |
| Standard Surgical Care Without DyePatients 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. | Other | Control Group |
Primary outcome
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).
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Background: PubMed 10050871Veronesi 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.
- Background: PubMed 11588440Kirov 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.
- Background: PubMed 12500513Memis 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mustafa Kemal Şahin principal investigator
Dr. Abdurrahman Yurtaslan Training and Research Hospital, University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Breast Surgery, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07040540, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.