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

NCT07068048 | Enrolling By Invitation

• 1 other identifier: MREC ID NO: 202456-13711
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Nerve Condition

Outcome Measures

Primary Outcomes (1)

• 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

  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

  Three week post surgery

Study Arms (2)

Intra-operative Water for Injection for Irrigation for Post-thyroidectomy

PLACEBO COMPARATOR

For the placebo group, they will received water irrigation over the operative field only which is the current standard of practice at the moment.

Drug: Water for injection

Intra-operative Dexamethasone Irrigation for Reducing Recurrent Laryngeal Nerve Palsy

ACTIVE COMPARATOR

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: Dexametasone

Interventions

Dexametasone DRUG

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.

Intra-operative Dexamethasone Irrigation for Reducing Recurrent Laryngeal Nerve Palsy

Water for injection DRUG

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 Water for Injection for Irrigation for Post-thyroidectomy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Vocal cord paresis before surgery
• No consent
• Allergy towards dexamethasone
• Surgery involved neck dissection
• Retrosternal goitre

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

UMMC

Petaling Jaya, Selangor, 50603, Malaysia

Location

MeSH Terms

Interventions

Water; Injections

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master Student

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 16, 2025
• Study Start: August 30, 2024
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)