Nerve Condition
Conditions
Brief 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. 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
DRUGDexametasone
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.
For the placebo group, they will received water irrigation over the operative field only which is the current standard of practice at the moment.
Sponsors
University of Malaya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
Countries
Malaysia
Outcome results
None listed