Nerve ConditionNCT07068048
Intra-operative Steroid Irrigation for Reducing Recurrent Laryngeal Nerve Palsy Post-thyroidectomy
A study testing Dexametasone and Water for injection in people with Nerve Condition, run by University of Malaya at 1 site in Malaysia.
Trial summary
The main aim of this study is to elucidate whether the topical irrigation of steroid during thyroid surgery can reduce the rate of recurrent laryngeal nerve palsy as majority of nerve dysfunction was due to neuropraxia to axonotmesis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Nerve Condition
- What is being tested?
- Dexametasone and Water for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteMalaysia
- Study dates
- 30 Aug 2024to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The target population are patients who scheduled for thyroidectomy (include both total or hemithyroidectomy) under UMMC
- Age between 18 years old till 80 years old
Who cannot join
- Vocal cord paresis before surgery
- No consent
- Allergy towards dexamethasone
- Surgery involved neck dissection
- Retrosternal goitre
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The main aim of this study is to elucidate whether the topical irrigation of steroid during thyroid surgery can reduce the rate of recurrent laryngeal nerve palsy as majority of nerve dysfunction was due to neuropraxia to axonotmesis.
Intra-operatively, all participants recruited must have the recurrent laryngeal nerve identify and confirm with Intraoperative Nerve Monitoring (IONM) device.
Read more
After removal of thyroid gland, 8mg of dexamethasone will be diluted in 100cc of irrigation water and irrigate the operative field for 1 minute for the intervention group.
However for the placebo group, they will received water irrigation over the operative field only which is the current standard of practice at the moment.
Both the otolaryngologist and patient are blinded throughout the whole study.
- Conditions
- Nerve Condition
- Being tested
- Dexametasone, Water for injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexametasoneDrug
Intra-operatively, all participants recruited must have the recurrent laryngeal nerve identify and confirm with Intraoperative Nerve Monitoring (IONM) device.
After removal of thyroid gland, 8mg of dexamethasone will be diluted in 100cc of irrigation water and irrigate the operative field for 1 minute for the intervention group.
Water for injectionDrug
For the placebo group, they will received water irrigation over the operative field only which is the current standard of practice at the moment.
| Study group | Role | What they receive |
|---|---|---|
| Intra-operative Water for Injection for Irrigation for Post-thyroidectomy | Placebo comparator | For the placebo group, they will received water irrigation over the operative field only which is the current standard of practice at the moment. Receives: Drug: Water for injection |
| Intra-operative Dexamethasone Irrigation for Reducing Recurrent Laryngeal Nerve Palsy | Active comparator | Intra-operatively, all participants recruited must have the recurrent laryngeal nerve identify and confirm with Intraoperative Nerve Monitoring (IONM) device.
After removal of thyroid gland, 8mg of dexamethasone will be diluted in 100cc of irrigation water and irrigate the operative field for 1 minute for the intervention group. Receives: Drug: Dexametasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post thyroidectomy vocal cord assessment will be performed by otolaryngologist within 3 weeks after surgery by using indirect larygoscopy, to look for any vocal cord palsy
if both the vocal cord mobile equally with no phonation gap, indicated no vocal cord palsy if any of the vocal cord paralysed with phonation gap, indicated vocal cord palsy
Measured: Three week post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start30 Aug 2024
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nerve ConditionStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chua Jenna, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07068048
- Sponsor's protocol ID
- MREC ID NO: 202456-13711
- Status last verified
- Jul 2025
- First submitted
- 23 Jun 2025
- Last updated
- 16 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-operative Steroid Irrigation for Reducing Recurrent Laryngeal Nerve Palsy Post-thyroidectomy
- ClinicalTrials.gov ID
- NCT07068048
- Acronym / sponsor ID
- MREC ID NO: 202456-13711
- Conditions
- Nerve Condition
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 30 Aug 2024 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 16 Jul 2025 (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.
The main aim of this study is to elucidate whether the topical irrigation of steroid during thyroid surgery can reduce the rate of recurrent laryngeal nerve palsy as majority of nerve dysfunction was due to neuropraxia to axonotmesis.
Intra-operatively, all participants recruited must have the recurrent laryngeal nerve identify and confirm with Intraoperative Nerve Monitoring (IONM) device.
After removal of thyroid gland, 8mg of dexamethasone will be diluted in 100cc of irrigation water and irrigate the operative field for 1 minute for the intervention group.
However for the placebo group, they will received water irrigation over the operative field only which is the current standard of practice at the moment.
Both the otolaryngologist and patient are blinded throughout the whole study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intra-operative Water for Injection for Irrigation for Post-thyroidectomy | Placebo comparator | Drug: Water for injectionFor the placebo group, they will received water irrigation over the operative field only which is the current standard of practice at the moment. |
| Intra-operative Dexamethasone Irrigation for Reducing Recurrent Laryngeal Nerve Palsy | Active comparator | Drug: DexametasoneIntra-operatively, all participants recruited must have the recurrent laryngeal nerve identify and confirm with Intraoperative Nerve Monitoring (IONM) device. After removal of thyroid gland, 8mg of dexamethasone will be diluted in 100cc of irrigation water and irrigate the operative field for 1 minute for the intervention group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The target population are patients who scheduled for thyroidectomy (include both total or hemithyroidectomy) under UMMC
- Age between 18 years old till 80 years old
Key exclusion criteria (5 listed)
- Vocal cord paresis before surgery
- No consent
- Allergy towards dexamethasone
- Surgery involved neck dissection
- Retrosternal goitre
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 |
|---|---|---|
| DexametasoneIntra-operatively, all participants recruited must have the recurrent laryngeal nerve identify and confirm with Intraoperative Nerve Monitoring (IONM) device. After removal of thyroid gland, 8mg of dexamethasone will be diluted in 100cc of irrigation water and irrigate the operative field for 1 minute for the intervention group. | Drug | Intra-operative Dexamethasone Irrigation for Reducing Recurrent Laryngeal Nerve Palsy |
| Water for injectionFor the placebo group, they will received water irrigation over the operative field only which is the current standard of practice at the moment. | Drug | Intra-operative Water for Injection for Irrigation for Post-thyroidectomy |
Primary outcome
Post thyroidectomy vocal cord assessment will be performed by otolaryngologist within 3 weeks after surgery by using indirect larygoscopy, to look for any vocal cord palsy
Time frame: Three week post surgery
if both the vocal cord mobile equally with no phonation gap, indicated no vocal cord palsy if any of the vocal cord paralysed with phonation gap, indicated vocal cord palsy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexametasone and Water for injection in people with Nerve Condition, run by University of Malaya at 1 site in Malaysia.
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 2 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: enrolling by invitation, as of the sponsor's last update on 16 Jul 2025. 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 Malaysia. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
Post thyroidectomy vocal cord assessment will be performed by otolaryngologist within 3 weeks after surgery by using indirect larygoscopy, to look for any vocal cord palsy (time frame: Three week post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jul 2025.