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

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.

Study Overview

• Status: Completed
• Conditions: Recurrent Laryngeal Nerve Injuries; Parathyroid Gland; Methylene Blue
• Intervention / Treatment: Diagnostic test: methylene blue identification

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

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Zagazig, Egypt, 44511
    • Zagazig University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Zagazig University

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2020
• Primary Completion (Actual): June 10, 2021
• Study Completion (Actual): July 15, 2021

Study Registration Dates

• First Submitted: October 28, 2021
• First Submitted That Met QC Criteria: October 28, 2021
• First Posted (Actual): November 9, 2021

Study Record Updates

• Last Update Posted (Actual): November 9, 2021
• Last Update Submitted That Met QC Criteria: October 28, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Wounds and Injuries; Disease Attributes; Otorhinolaryngologic Diseases; Craniocerebral Trauma; Trauma, Nervous System; Cranial Nerve Diseases; Laryngeal Diseases; Cranial Nerve Injuries; Vagus Nerve Injuries; Recurrence; Laryngeal Nerve Injuries; Recurrent Laryngeal Nerve Injuries; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Methylene Blue
• Other Study ID Numbers: Methylene blue

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No