NCT07068048

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Malaya · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nerve Condition

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-08-30
• Primary completion: 2026-08-30
• Completion: 2026-08-30
• First posted: 2025-07-16
• Last updated: 2025-07-16

Locations

1 site across 1 country: Malaysia