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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methylene Blue labelling | Experimental |
| |
| Conventional Dissection | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraoperative topical methylene blue spray | Procedure | Intraoperative topical spray of 0.5 mL methylene blue applied to the thyroid lobe and surrounding tissue after mobilization. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Awais Amjad Malik, MBBS, FCPS | Services Institute of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Services Institute of Medical Sciences | Lahore | Punjab Province | 54000 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. | ||
| 30697498 | Background | 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. | |
| 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. |
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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.
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| Conventional Dissection | Procedure | Conventional visual identification and dissection without dye. |
|
| ID | Term |
|---|---|
| D061226 | Recurrent Laryngeal Nerve Injuries |
| D007011 | Hypoparathyroidism |
| D006996 | Hypocalcemia |
| ID | Term |
|---|---|
| D061224 | Laryngeal Nerve Injuries |
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D061223 | Vagus Nerve Injuries |
| D020209 | Cranial Nerve Injuries |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
| D002128 | Calcium Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D014883 | Water-Electrolyte Imbalance |
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