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

Not Applicable

• Conditions: Nerve Condition
• Interventions: Drug: Water for injection; Drug: Dexametasone

• Registration Number: NCT07068048
• Lead Sponsor: University of Malaya

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-30
• Study First Submitted: 2025-06-23
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-13
• Last Update Submitted: 2025-07-13
• Study First Posted: 2025-07-16
• Last Update Posted: 2025-07-16
• Primary Completion: 2026-08-30
• Study Completion: 2026-08-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intra-operative Water for Injection for Irrigation for Post-thyroidectomy	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.
Intra-operative Dexamethasone Irrigation for Reducing Recurrent Laryngeal Nerve Palsy	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

UMMC; 🇲🇾 Petaling Jaya, Selangor, Malaysia