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

NCT ID: NCT05113628

Last Updated: 2021-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-15

Study Completion Date

2021-07-15

Brief Summary

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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

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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

Conditions

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Methylene Blue Recurrent Laryngeal Nerve Injuries Parathyroid Gland

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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anatomical identification

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type SHAM_COMPARATOR

methylene blue identification

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zagazig University

OTHER_GOV

Sponsor Role lead

Responsible Party

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Yasser Ali Orban

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zagazig university hospitals

Zagazig, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Methylene blue

Identifier Type: -

Identifier Source: org_study_id