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NCT Number: NCT07395388

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

This randomized controlled trial aims to evaluate the efficacy of intraoperative methylene blue (MB) spray in improving the identification and preservation of the recurrent laryngeal nerve (RLN) and parathyroid glands (PGs) during thyroidectomy. 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.

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Key information

Conditions

Benign Multinodular Goiter Calcium Metabolism Disorders Cranial Nerve Diseases Cranial Nerve Injuries Craniocerebral Trauma Endocrine System Diseases Hypocalcemia Hypoparathyroidism Laryngeal Diseases Laryngeal Nerve Injuries Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Otorhinolaryngologic Diseases Parathyroid Diseases Recurrent Laryngeal Nerve Injuries Recurrent Laryngeal Nerve Injury Respiratory Tract Diseases Thyroidectomy Trauma, Nervous System Vagus Nerve Injuries Water-Electrolyte Imbalance Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Services Institute of Medical Sciences

Lahore, Punjab Province, 54000, Pakistan

About this study

Thyroidectomy is associated with risks of iatrogenic injury to the RLN and PGs, leading to vocal cord paralysis and hypocalcemia. 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 can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • benign multinodular goiter scheduled for thyroidectomy.

Exclusion criteria

  • Recurrent/metastatic disease
  • Preoperative vocal cord dysfunction
  • Coagulopathy
  • Methylene blue allergy
  • Hepatic/renal impairment

Treatment and study plan

Intraoperative topical methylene blue spray

Procedure

Intraoperative topical spray of 0.5 mL methylene blue applied to the thyroid lobe and surrounding tissue after mobilization.

Conventional Dissection

Procedure

Conventional visual identification and dissection without dye.

Primary outcomes

  1. Incidence of recurrent laryngeal nerve injury

    Time frame: 2 hours (at extubation)

    Incidence of recurrent laryngeal nerve injury (assessed by indirect laryngoscopy

  2. Postoperative serum calcium levels

    Time frame: At 72 hours

    Postoperative serum calcium levels

Sponsors and collaborators

Lead sponsor

Services Hospital, Lahore

Other Gov

Registry information

Official study title

Intraoperative Methylene Blue Spray for the Identification and Preservation of Vital Structures in Thyroidectomy: A Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Feb 9, 2026
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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