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Blue Dye's hidden effect on blood pressure during breast surgery revealed

NCT ID NCT07040540

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at 220 women having breast surgery to see if a blue dye called methylene blue, used to find lymph nodes, changes blood pressure or heart rate during anesthesia. The researchers compared women who got the dye with those who did not. The goal was to learn if the dye helps keep blood pressure stable or causes drops that need extra medicine.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

220 people

The number who actually took part.

Started

Jul 2025

Finished

Jan 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 to 70 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

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

    Ankara, Yenimahalle, 06200, Turkey (Türkiye)

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