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CompletedNCT05113628Updated Nov 9, 2021

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

An interventional study of methylene blue identification in Methylene Blue, Recurrent Laryngeal Nerve Injuries and Parathyroid Gland, sponsored by Zagazig University. Completed at 1 site in Egypt. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2021-11-09.

Sponsored by Zagazig University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year 9 months after the study started (first participant enrolled Jan 2020, registered Oct 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
16 Years and older
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Methylene Blue
  • Recurrent Laryngeal Nerve Injuries
  • Parathyroid Gland

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03

In context

Recurrence

4,279 studies on the registry are indexed under Recurrence; 988 are open to participants now.

This study's enrollment of 80 is above the median of 50 across 3,374 interventional studies indexed under Recurrence.

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Lead sponsor

Zagazig University is the lead sponsor of 447 studies on the registry; 75 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (actual)

Study arms

  • No intervention
    anatomical identification

    thyroidectomy was done with identification of both RLN and parathyroid gland done on anatomical basis

  • Sham comparator
    methylene blue identification

    thyroidectomy was done with identification of both RLN and parathyroid gland done using methylene blue spray (0.5 ml methylene blue 2% was diluted by 5ml normal saline) was sprayed over the lower thyroid pole and the perilobar area

    Diagnostic Test: methylene blue identification

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.

06

What researchers measure

Primary outcomes

  1. detection of the recurrent larngeal nerve unstained

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

    Time frame: one minute after dye application

  2. detection of the parathyroig glands

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

    Time frame: 3 minutes after dye application

07

Study locations

1 site
  • Zagazig university hospitals
    Zagazig, 44511, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 9, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05113628
Lead sponsor
Zagazig University
Responsible party
Yasser Ali Orban (Dr, Zagazig University) — Principal investigator
First posted
Nov 9, 2021
Start date
Jan 15, 2020
Primary completion
Jun 10, 2021
Completion
Jul 15, 2021
Last update
Nov 9, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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