Trials / Completed
CompletedNCT07395388
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
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 136 (actual)
- Sponsor
- Services Hospital, Lahore · Other Government
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Intraoperative topical methylene blue spray | Intraoperative topical spray of 0.5 mL methylene blue applied to the thyroid lobe and surrounding tissue after mobilization. |
| PROCEDURE | Conventional Dissection | Conventional visual identification and dissection without dye. |
Timeline
- Start date
- 2022-01-10
- Primary completion
- 2025-12-31
- Completion
- 2026-01-20
- First posted
- 2026-02-09
- Last updated
- 2026-02-09
Locations
1 site across 1 country: Pakistan
Source: ClinicalTrials.gov record NCT07395388. Inclusion in this directory is not an endorsement.