Actively Recruiting

Phase 2
Age: 18Years +
All Genders
Healthy Volunteers
ID05732883

The Use of Dexamethasone in Total Thyroidectomy to Improve Voice Outcome and Hypocalcaemia

Led by Tseung Kwan O Hospital, Hong Kong · Updated on 2024-07-09

100

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

Sponsors

T

Tseung Kwan O Hospital, Hong Kong

Lead Sponsor

U

United Christian Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of Dexamethasone on voice outcomes and hypocalcaemia in patients undergoing total thyroidectomy for benign thyroid conditions such as multinodular goitre, toxic nodular goitre, and Graves' disease. This randomized, double-blind, placebo-controlled trial aims to improve understanding of post-operative voice dysfunction and calcium level changes, which commonly affect patients after thyroid surgery. The study also explores the mechanisms of voice dysfunction using objective assessments. Participants will receive one dose of 8mg Dexamethasone injection or a placebo of 2ml normal saline during the peri-operative period. To reduce variability, surgical and anesthesia techniques are standardized across multiple hospital departments. Voice and vocal cord function will be assessed pre- and post-operatively using video stroboscopy and standardized voice assessments conducted by speech therapists. Calcium and parathyroid hormone levels will be monitored to evaluate hypocalcaemia. Throughout the study, participants will undergo voice assessments and blood tests at several time points: 1 week, 3 months, and 6 months after surgery. Researchers will measure voice handicap scores, perceptual and acoustic evaluations, aerodynamic voice function, and stroboscopic vocal cord characteristics. They will also track calcium and medication requirements and monitor for possible side effects such as wound infection. The total participation period extends up to 6 months post-operation, with careful safety monitoring during this time.

CONDITIONS

Brief Title

The Use of Dexamethasone in Total Thyroidectomy to Improve Voice Outcome and Hypocalcaemia

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 or above
  • Patients undergoing total thyroidectomy for benign thyroid conditions
  • Multinodular goitre (MNG)
  • Toxic nodular goitre
  • Graves' disease
Not Eligible

You will not qualify if you...

  • Unable to communicate effectively
  • Contraindication for steroids (diabetes mellitus, hepatitis carrier, tuberculosis, peptic ulcer disease)
  • Contraindication for analgesics including Panadol, Celebrex, Tramadol, or Levobupivacaine
  • Malignant thyroid disease
  • Previous thyroid or neck surgery
  • Pre-existing hoarseness of voice or vocal cord palsy
  • Pregnancy or lactating female patients
  • Pre-existing renal disease or autoimmune disease on steroids
  • Requires steroid cover during operation (e.g., hydrocortisone perioperatively)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - One day (day of surgery)

Participants receive a single dose of either 8mg Dexamethasone or placebo injection during their total thyroidectomy surgery.

1 visit (in-person surgery day)

Surgery and Immediate Post-operative Care

Duration - Up to 1 week post-surgery

Participants undergo total thyroidectomy with standardized surgical and anaesthetic protocols, including assessment of voice and vocal cord mobility.

Visits on post-operative day 1 and post-operative week 1

Post-operative Follow-up

Duration - 6 months post-surgery

Participants are followed up to assess voice outcomes and hypocalcaemia through objective and subjective measures, including voice assessments and calcium monitoring.

Visits at 1 week, 3 months, and 6 months post-operatively

Trial Site Locations

Total: 1 location

1

Department of Otorhinolaryngology, Head and Neck Surgery, United Christian Hospital and Tseung Kwan O Hospital

Hong Kong, Hong Kong

Actively Recruiting

Loading map...

Research Team

C

Cherrie Ng

T

Thomas Hui, BSc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

Similar Trials

Effectiveness of Intraoperative Neuromonitoring to Identify ...

Laryngeal Nerve Injuries

Actively Recruiting

1 location

A Ten-Year Cohort Study of Clinical and Surgical Predictors ...

Thyroid Nodule

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here