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

Recurrent Laryngeal Nerve Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05113628
• Other study ID #: Methylene blue
• Status: Completed
• Phase: N/A
• Start date: January 15, 2020
• Est. completion date: July 15, 2021

Study information

• Verified date: October 2021
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 15, 2021
• Est. primary completion date: June 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Methylene Blue
• Parathyroid Gland
• Recurrent Laryngeal Nerve Injuries

Intervention

Diagnostic Test:
• methylene blue identification
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.

Locations

Country	Name	City	State
Egypt	Zagazig university hospitals	Zagazig

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	detection of the recurrent larngeal nerve unstained	the methylene blue dye stain the background and the RLN appears unstained	one minute after dye application
Primary	detection of the parathyroig glands	the methylene blue dye stain washed out and the parathyroid gland remained stained after 3 minutes	3 minutes after dye application