ClinicalTrials.gg
CompletedNCT07395388Updated Feb 9, 2026

Intraoperative Methylene Blue Spray for the Identification and Preservation of Vital Structures in Thyroidectomy

An interventional study of Intraoperative topical methylene blue spray and Conventional Dissection in Benign Multinodular Goiter, Thyroidectomy and Recurrent Laryngeal Nerve Injury, sponsored by Services Hospital, Lahore. Completed at 1 site in Pakistan. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-02-09.

Sponsored by Services Hospital, Lahore · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 4 years after the study started (first participant enrolled Jan 2022, registered Feb 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
136
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the detailed description

Thyroidectomy is associated with risks of iatrogenic injury to the RLN and PGs, leading to vocal cord paralysis and hypocalcemia. This study investigates whether topical application of methylene blue spray can enhance intraoperative visualization and preservation of these structures. A total of 136 patients with benign multinodular goiter were randomized into two groups: an experimental group receiving MB spray and a control group receiving conventional dissection. RLN injury was assessed via postoperative laryngoscopy, and serum calcium levels were measured at 72 hours postoperatively.

02

Conditions studied

  • Benign Multinodular Goiter
  • Thyroidectomy
  • Recurrent Laryngeal Nerve Injury
  • Hypoparathyroidism

Keywords

  • Thyroidectomy
  • Methylene Blue
  • Recurrent Laryngeal Nerve Injury
  • Hypocalcemia
  • Nerve Preservation
03

In context

Hypoparathyroidism

128 studies on the registry are indexed under Hypoparathyroidism; 30 are open to participants now.

This study's enrollment of 136 is above the median of 50 across 77 interventional studies indexed under Hypoparathyroidism.

Browse Hypoparathyroidism studies →

Lead sponsor

Services Hospital, Lahore is the lead sponsor of 33 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • benign multinodular goiter scheduled for thyroidectomy.

Exclusion criteria

Exclusion Criteria:

  • Recurrent/ disease
  • Preoperative vocal cord dysfunction
  • Coagulopathy
  • Methylene blue allergy
  • Hepatic/renal impairment
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
136 participants (actual)

Study arms

  • Experimental
    Methylene Blue labelling

    Procedure: Intraoperative topical methylene blue spray

  • Active comparator
    Conventional Dissection

    Procedure: Conventional Dissection

Interventions

  • ProcedureIntraoperative topical methylene blue spray

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

  • ProcedureConventional Dissection

    Conventional visual identification and dissection without dye.

06

What researchers measure

Primary outcomes

  1. Incidence of recurrent laryngeal nerve injury

    Incidence of recurrent laryngeal nerve injury (assessed by indirect laryngoscopy

    Time frame: 2 hours (at extubation)

  2. Postoperative serum calcium levels

    Postoperative serum calcium levels

    Time frame: At 72 hours

07

Study locations

1 site
  • Services Institute of Medical Sciences
    Lahore, Punjab Province 54000, Pakistan
08

References and documents

Publications

  • 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.
  • 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.
  • 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 Jan 23;7:e6376. doi: 10.7717/peerj.6376. eCollection 2019. PubMed 30697498 ↗
  • 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.

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07395388
Lead sponsor
Services Hospital, Lahore
Responsible party
Dr. SamiUllah (Doctor, Services Hospital, Lahore) — Principal investigator
First posted
Feb 9, 2026
Start date
Jan 10, 2022
Primary completion
Dec 31, 2025
Completion
Jan 20, 2026
Last update
Feb 9, 2026

Study contacts

Awais Amjad Malik, MBBS, FCPS
principal investigator · Services Institute of Medical Sciences

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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