NCT07395388

Brief Summary

This randomized controlled trial aims to evaluate the efficacy of intraoperative methylene blue (MB) spray in improving the identification and preservation of the recurrent laryngeal nerve (RLN) and parathyroid glands (PGs) during thyroidectomy. The study compares outcomes between patients receiving topical MB spray and those undergoing conventional visual dissection alone. Primary outcomes include the incidence of RLN injury and postoperative serum calcium levels.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2022

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2026

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

February 1, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 9, 2026

Completed
Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

4 years

First QC Date

February 1, 2026

Last Update Submit

February 1, 2026

Conditions

Benign Multinodular GoiterThyroidectomyRecurrent Laryngeal Nerve InjuryHypoparathyroidism

Keywords

ThyroidectomyMethylene BlueRecurrent Laryngeal Nerve InjuryHypocalcemiaNerve Preservation

Outcome Measures

Primary Outcomes (2)

  • Incidence of recurrent laryngeal nerve injury

    Incidence of recurrent laryngeal nerve injury (assessed by indirect laryngoscopy

    2 hours (at extubation)

  • Postoperative serum calcium levels

    Postoperative serum calcium levels

    At 72 hours

Study Arms (2)

Methylene Blue labelling

EXPERIMENTAL
Procedure: Intraoperative topical methylene blue spray

Conventional Dissection

ACTIVE COMPARATOR
Procedure: Conventional Dissection

Interventions

Intraoperative topical methylene blue sprayPROCEDURE

Intraoperative topical spray of 0.5 mL methylene blue applied to the thyroid lobe and surrounding tissue after mobilization.

Methylene Blue labelling
Conventional DissectionPROCEDURE

Conventional visual identification and dissection without dye.

Conventional Dissection

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • benign multinodular goiter scheduled for thyroidectomy.

You may not qualify if:

  • Recurrent/metastatic disease
  • Preoperative vocal cord dysfunction
  • Coagulopathy
  • Methylene blue allergy
  • Hepatic/renal impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Services Institute of Medical Sciences

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (4)

  • 6. Farghaly AEA, Ahmed MT, Kotb MB, Ibrahim IA. Conventional surgical techniques versus intraoperative methylene blue spraying for safe total thyroidectomy. J Curr Med Res Pract. 2019;4(1):67-71.

    BACKGROUND

  • 7. Sebaey AE, Khalil AM, Elkilany MM, Ali RM. Recurrent laryngeal nerve identification in thyroidectomy by intraoperative staining with methylene blue. Eur J Mol Clin Med. 2021;8(2):644-9.

    BACKGROUND

  • 8. Piromchai P, Juengtrakool T, Laohasiriwong S, Kasemsiri P, Ungarereevittaya P. The sensitivity and specificity of methylene blue spray to identify the parathyroid gland during thyroidectomy. PeerJ. 2019;7:e6376.

    BACKGROUND

  • 1. Eldeen Abdulrahman ZN, Rajab WQ, Jameel Ali Z. Identification of recurrent laryngeal nerve and parathyroid glands intraoperatively by methylene blue spraying technique. Indian J Forensic Med Toxicol. 2020;14(1):1355-60.

    BACKGROUND

MeSH Terms

Conditions

Recurrent Laryngeal Nerve InjuriesHypoparathyroidismHypocalcemia

Condition Hierarchy (Ancestors)

Laryngeal Nerve InjuriesLaryngeal DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesVagus Nerve InjuriesCranial Nerve InjuriesCranial Nerve DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesParathyroid DiseasesEndocrine System DiseasesCalcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesWater-Electrolyte Imbalance

Study Officials

  • Awais Amjad Malik, MBBS, FCPS

    Services Institute of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Experimental Group: Intraoperative topical spray of 0.5 mL methylene blue applied to the thyroid lobe and surrounding tissue after mobilization. Control Group: Conventional visual identification and dissection without dye.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

February 1, 2026

First Posted

February 9, 2026

Study Start

January 10, 2022

Primary Completion

December 31, 2025

Study Completion

January 20, 2026

Last Updated

February 9, 2026

Record last verified: 2026-02

Locations

PA(1)