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

Intraoperative Methylene Blue Spray for the Identification and Preservation of Vital Structures in Thyroidectomy: A Randomized Controlled Trial

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07395388

Enrollment

136

Registered

2026-02-09

Start date

2022-01-10

Completion date

2026-01-20

Last updated

2026-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Thyroidectomy, Methylene Blue, Recurrent Laryngeal Nerve Injury, Hypocalcemia, Nerve Preservation

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.

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.

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Intervention model description

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.

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

* benign multinodular goiter scheduled for thyroidectomy.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Incidence of recurrent laryngeal nerve injury	2 hours (at extubation)	Incidence of recurrent laryngeal nerve injury (assessed by indirect laryngoscopy
Postoperative serum calcium levels	At 72 hours	Postoperative serum calcium levels

Countries

Pakistan

Contacts

PRINCIPAL_INVESTIGATORAwais Amjad Malik, MBBS, FCPS

Services Institute of Medical Sciences

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026