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NCT Number: NCT05113628

Methylene Blue Spray for Identification of Recurrent Laryngeal Nerve and Parathyroid Gland

Thyroidectomy is the procedure by which surgeons treat various thyroid diseases and is considered the commonest endocrinal surgery. Yet, it carries a risk for intraoperative complications. The most distressing complications are recurrent laryngeal nerve and parathyroid injuries. Methylene blue spray is a technique than can be used for easy identification of both recurrent laryngeal nerve and parathyroid glands so we can avoid their injuries.

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Key information

About this study

Thyroid disorders constitute the second most common endocrine disease following diabetes mellitus. Thyroid surgery is one of the most frequently operated Head and Neck surgeries. Post-thyroidectomy complications are not uncommon. Parathyroids and Recurrent Laryngeal Nerve (RLN) are two of the complications of thyroidectomy that cause significant postoperative morbidity Due to the advances in thyroids surgeries, the occurrence of postoperative complications has been decreased, but when occurred, they cause lifelong handicap. The most important complications encountered are injury to the RLN and parathyroids. Meticulous dissection is a key factor in minimizing the occurrence of complications During thyroidectomy, careful dissection can protect the parathyroid glands and RLN. Various methods were used including capsular dissection, attention to protection of the arterial supply to parathyroids, avoiding unnecessary manipulation in the area of RLN Methylene blue spraying is a new technique that allows identification of both parathyroid glands and recurrent laryngeal nerves

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age of 16 years and older.
  • Both sexes.
  • Patients who are candidate for thyroid surgery and euthyroid.

Exclusion criteria

  • - Patients with hyper- or hypo-thyroid status.
  • Patients who were unfit for surgery.
  • Patients with unilateral or bilateral vocal cord palsy on preoperative indirect laryngoscopy
  • Patients with thyroid malignancy by preoperative FNAC.
  • Patients with hypersensitivity to methylene blue were excluded.

Treatment and study plan

methylene blue identification

Diagnostic Test

After ligation of the middle thyroid vein and the upper pole of the thyroid, the thyroid lobe was retracted medially and diluted methylene blue (0.5 ml methylene blue 2% was diluted by 5ml normal saline) was sprayed over the lower thyroid pole and the perilobar area. This area contains structures including recurrent laryngeal nerve, parathyroid glands, and inferior thyroid vessels which were observed After spraying.

The vocal cord mobility was assessed intraoperatively by the anesthesiologist at time of extubation. The serum calcium was measured on the 2nd postoperative day. There was no routine use of postoperative calcium supplementation. Hypocalcemia was defined when the serum calcium level was less than 8 mg/dl.

Primary outcomes

  1. detection of the recurrent larngeal nerve unstained

    Time frame: one minute after dye application

    the methylene blue dye stain the background and the RLN appears unstained

  2. detection of the parathyroig glands

    Time frame: 3 minutes after dye application

    the methylene blue dye stain washed out and the parathyroid gland remained stained after 3 minutes

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

Methylene Blue Spray for Identification of Recurrent Laryngeal Nerve and Parathyroid Glands During Thyroidectomy: A Randomized Controlled Trial

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 9, 2021
Registry last updated
Nov 9, 2021

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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