Intra-operative Steroid Irrigation for Reducing Recurrent Laryngeal Nerve Palsy Post-thyroidectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dexametasone, Water for injection.
- Who it may be relevant to
- Registry conditions: Nerve Condition. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Malaysia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Drug Dexametasone
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. - Drug Water for injection
For the placebo group, they will received water irrigation over the operative field only which is the current standard of practice at the moment.
Primary outcome measures
- 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]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Vocal cord paresis before surgery
- No consent
- Allergy towards dexamethasone
- Surgery involved neck dissection
- Retrosternal goitre
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Malaysia · 1 center
- UMMC — Petaling Jaya
Identifiers
NCT: NCT07068048 · MREC ID NO: 202456-13711