Benign Multinodular GoiterNCT07395388
Intraoperative Methylene Blue Spray for the Identification and Preservation of Vital Structures in Thyroidectomy
A study testing Intraoperative topical methylene blue spray and Conventional Dissection in people with Benign Multinodular Goiter and Thyroidectomy, run by Services Hospital, Lahore at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Benign Multinodular Goiter, Thyroidectomy, Recurrent Laryngeal Nerve Injury
- What is being tested?
- Intraoperative topical methylene blue spray and Conventional Dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Jan 2022to 20 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- benign multinodular goiter scheduled for thyroidectomy.
Who cannot join
- Recurrent/metastatic disease
- Preoperative vocal cord dysfunction
- Coagulopathy
- Methylene blue allergy
- Hepatic/renal impairment
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Services Institute of Medical Sciences
Lahore, Punjab Province, 54000
About this study
Official title: Intraoperative Methylene Blue Spray for the Identification and Preservation of Vital Structures in Thyroidectomy: A Randomized Controlled Trial
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.
- Conditions
- Benign Multinodular Goiter, Thyroidectomy, Recurrent Laryngeal Nerve Injury, Hypoparathyroidism
- Being tested
- Intraoperative topical methylene blue spray, Conventional Dissection
- Keywords
- Thyroidectomy, Methylene Blue, Recurrent Laryngeal Nerve Injury, Hypocalcemia, Nerve Preservation
- Medical subject headings
- Recurrent Laryngeal Nerve Injuries, Hypoparathyroidism, Hypocalcemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative topical methylene blue sprayProcedure or surgery
Intraoperative topical spray of 0.5 mL methylene blue applied to the thyroid lobe and surrounding tissue after mobilization.
Conventional DissectionProcedure or surgery
Conventional visual identification and dissection without dye.
| Study group | Role | What they receive |
|---|---|---|
| Methylene Blue labelling | Experimental | Not described Receives: Procedure: Intraoperative topical methylene blue spray |
| Conventional Dissection | Active comparator | Not described Receives: Procedure: Conventional Dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of recurrent laryngeal nerve injury
Incidence of recurrent laryngeal nerve injury (assessed by indirect laryngoscopy
Measured: 2 hours (at extubation)
Postoperative serum calcium levels
Postoperative serum calcium levels
Measured: At 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start10 Jan 2022
- Primary completion31 Dec 2025
- Study completion20 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Benign Multinodular GoiterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Services Hospital, Lahore
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. SamiUllah, Services Hospital, Lahore
- Investigators
- Awais Amjad Malik, MBBS, FCPS, Principal investigator, Services Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07395388
- Sponsor's protocol ID
- RCT22SIMS
- Status last verified
- Feb 2026
- First submitted
- 1 Feb 2026
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 306974981. 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Methylene Blue Spray for the Identification and Preservation of Vital Structures in Thyroidectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07395388
- Acronym / sponsor ID
- RCT22SIMS
- Conditions
- Benign Multinodular Goiter, Thyroidectomy, Recurrent Laryngeal Nerve Injury, Hypoparathyroidism
- Keywords
- Thyroidectomy, Methylene Blue, Recurrent Laryngeal Nerve Injury, Hypocalcemia, Nerve Preservation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Services Hospital, LahoreOther government
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 20 Jan 2026 (actual)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Methylene Blue labelling | Experimental | Procedure: Intraoperative topical methylene blue spray |
| Conventional Dissection | Active comparator | Procedure: Conventional Dissection |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- benign multinodular goiter scheduled for thyroidectomy.
Key exclusion criteria (5 listed)
- Recurrent/metastatic disease
- Preoperative vocal cord dysfunction
- Coagulopathy
- Methylene blue allergy
- Hepatic/renal impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraoperative topical methylene blue sprayIntraoperative topical spray of 0.5 mL methylene blue applied to the thyroid lobe and surrounding tissue after mobilization. | Procedure or surgery | Methylene Blue labelling |
| Conventional DissectionConventional visual identification and dissection without dye. | Procedure or surgery | Conventional Dissection |
Primary outcome
Incidence of recurrent laryngeal nerve injury
Time frame: 2 hours (at extubation)
Incidence of recurrent laryngeal nerve injury (assessed by indirect laryngoscopy
Postoperative serum calcium levels
Time frame: At 72 hours
Postoperative serum calcium levels
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Background6. 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.
- Background7. 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: PubMed 30697498Piromchai 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.
- Background1. 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 dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Awais Amjad Malik, MBBS, FCPS principal investigator
Services Institute of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoperative topical methylene blue spray and Conventional Dissection in people with Benign Multinodular Goiter and Thyroidectomy, run by Services Hospital, Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of recurrent laryngeal nerve injury (time frame: 2 hours (at extubation)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07395388, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026; AzTrials last refreshed its copy on 7 Nov 2026.