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

NCT05113628 | Completed

• 1 other identifier: Methylene blue
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Methylene Blue; Recurrent Laryngeal Nerve Injuries; Parathyroid Gland

Outcome Measures

Primary Outcomes (2)

• detection of the recurrent larngeal nerve unstained

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

  one minute after dye application

• 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

Study Arms (2)

anatomical identification

NO INTERVENTION

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

methylene blue identification

SHAM COMPARATOR

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

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After ligation of the middle thyroid vein and the upper pole of the thyroid, the thyroid lobe was retracted medially and diluted methylene blue (0.5 ml methylene blue 2% was diluted by 5ml normal saline) was sprayed over the lower thyroid pole and the perilobar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

methylene blue identification

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig university hospitals

Zagazig, 44511, Egypt

Location

MeSH Terms

Conditions

Recurrent Laryngeal Nerve Injuries

Condition Hierarchy (Ancestors)

Laryngeal Nerve Injuries; Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Vagus Nerve Injuries; Cranial Nerve Injuries; Cranial Nerve Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: October 28, 2021
• First Posted: November 9, 2021
• Study Start: January 15, 2020
• Primary Completion: June 10, 2021
• Study Completion: July 15, 2021
• Last Updated: November 9, 2021

Record last verified: 2021-10

Locations

EG (1)