Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
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
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
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
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