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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05113628
Enrollment
80
Registered
2021-11-09
Start date
2020-01-15
Completion date
2021-07-15
Last updated
2021-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Methylene Blue, Parathyroid Gland, Recurrent Laryngeal Nerve Injuries

Brief 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.

Detailed 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

Interventions

DIAGNOSTIC_TESTmethylene 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After ligation of the middle thyroid vein and the upper pole of the thyroid, the thyroid lobe was retracted medially and diluted methylene blue (0.5 ml methylene blue 2% was diluted by 5ml normal saline) was sprayed over the lower thyroid pole and the perilobar area.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.

Sponsors

Zagazig University
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
detection of the recurrent larngeal nerve unstainedone minute after dye applicationthe methylene blue dye stain the background and the RLN appears unstained
detection of the parathyroig glands3 minutes after dye applicationthe methylene blue dye stain washed out and the parathyroid gland remained stained after 3 minutes

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026