Intraoperative Methylene Blue Spray for the Identification and Preservation of Vital Structures in Thyroidectomy

What Was Tested

In this not phased trial, researchers set out to test Methylene blue (non-peptide stack partner).

The study compares outcomes between patients receiving topical MB spray and those undergoing conventional visual dissection alone.

Primary outcomes include the incidence of RLN injury and postoperative serum calcium levels.

It had two arms (groups): Methylene Blue labelling (experimental) and Conventional Dissection (active comparator).

The registry classes the interventions as procedure.

More on the Plan

This study investigates whether topical application of methylene blue spray can enhance intraoperative visualization and preservation of these structures.

A total of 136 patients with benign multinodular goiter were randomized into two groups: an experimental group receiving MB spray and a control group receiving conventional dissection.

RLN injury was assessed via postoperative laryngoscopy, and serum calcium levels were measured at 72 hours postoperatively.

Who Took Part

136 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Benign multinodular goiter scheduled for thyroidectomy.

The full record lists 1 inclusion and 5 exclusion criteria; among the exclusions: recurrent/metastatic disease; preoperative vocal cord dysfunction; methylene blue allergy.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

The participants were allocated by chance, so the Methylene blue (non-peptide stack partner) group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Methylene blue (non-peptide stack partner) study: the participants and staff both knew the treatment.

It started in 2022-01-10 with completion listed for 2025-12-31.

It ran at 1 site in Pakistan.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Incidence of recurrent laryngeal nerve injury (time frame: 2 hours (at extubation)). Postoperative serum calcium levels (time frame: At 72 hours).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Methylene blue (non-peptide stack partner) in 136 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Methylene blue (non-peptide stack partner) compound page, all human trials.