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

Sponsor

Zagazig University (Other)

Overall Status

Completed

CT.gov ID

NCT05113628

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Methylene Blue Recurrent Laryngeal Nerve Injuries Parathyroid Gland	Diagnostic Test: methylene blue identification	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jan 15, 2020

Actual Primary Completion Date :

Jun 10, 2021

Actual Study Completion Date :

Jul 15, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

detection of the recurrent larngeal nerve unstained [one minute after dye application]
the methylene blue dye stain the background and the RLN appears unstained
detection of the parathyroig glands [3 minutes after dye application]
the methylene blue dye stain washed out and the parathyroid gland remained stained after 3 minutes

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zagazig university hospitals	Zagazig		Egypt	44511

Sponsors and Collaborators

Zagazig University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yasser Ali Orban, Dr, Zagazig University

ClinicalTrials.gov Identifier:

NCT05113628

Other Study ID Numbers:

Methylene blue

First Posted:

Nov 9, 2021

Last Update Posted:

Nov 9, 2021

Last Verified:

Oct 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Recurrent Laryngeal Nerve Injuries

Laryngeal Nerve Injuries

Recurrence

Methylene Blue

Study Results

No Results Posted as of Nov 9, 2021