drugset / Trial / NCT07068048

Intra-operative Steroid Irrigation for Reducing Recurrent Laryngeal Nerve Palsy Post-thyroidectomy

NCT07068048 ↗

Enrolling by invitation 100 enrolled University of Malaya
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2024-08-30
Primary completion
2026-08-30
Completion
2026-08-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dexamethasone Small molecule 8 mg Topical

Indications

No indication recorded.