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OpenTrials
Enrolling by Invitation

NCT Number: NCT07068048

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

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.

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Key information

Conditions

Nerve Condition

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UMMC

Petaling Jaya, Selangor, 50603, Malaysia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 16, 2025
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.