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Enrolling by invitationNCT07068048Updated Jul 16, 2025

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

An interventional study of Dexametasone and Water for injection in Nerve Condition, sponsored by University of Malaya. Enrolling by invitation at 1 site in Malaysia. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-07-16.

Sponsored by University of Malaya · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Aug 2024, registered Jun 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Nerve Condition
03

In context

Lead sponsor

University of Malaya is the lead sponsor of 280 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Vocal cord paresis before surgery
  • No consent
  • Allergy towards dexamethasone
  • Surgery involved neck dissection
  • Retrosternal goitre
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Placebo comparator
    Intra-operative Water for Injection for Irrigation for Post-thyroidectomy

    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

  • Active comparator
    Intra-operative Dexamethasone Irrigation for Reducing Recurrent Laryngeal Nerve Palsy

    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

  • DrugDexametasone

    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.

  • DrugWater 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.

06

What researchers measure

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

    Time frame: Three week post surgery

07

Study locations

1 site
  • UMMC
    Petaling Jaya, Selangor 50603, Malaysia
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Jul 4, 2024
  • Informed consent form · Nov 1, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07068048
Lead sponsor
University of Malaya
Responsible party
Chua Jenna (Master Student, University of Malaya) — Principal investigator
First posted
Jul 16, 2025
Start date
Aug 30, 2024
Primary completion
Aug 30, 2026 (estimated)
Completion
Aug 30, 2026 (estimated)
Last update
Jul 16, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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