The Use of Dexamethasone in Total Thyroidectomy to Improve Voice Outcome and Hypocalcaemia
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Voice Change, Hypocalcemia
In brief
Thyroidectomy is a standard procedure for benign and malignant pathologies of the thyroid gland. Each year, some 100 total thyroidectomies are performed in Kowloon East Cluster, Hospital Authority, Hong Kong. Total thyroidectomy is associated with voice dysfunction and temporary hypocalcaemia in up to 80% and 50%, respectively. Previous study from our institute showed a 3% rate of permanent vocal cord palsy and 16% of permanent hypoparathyroidism requiring calcium and/or vitamin D supplements. The use of dexamethasone has been studied in the past in total thyroidectomy patients and has been shown to be safe and effective in improving post-operative nausea and vomiting. No complications or drug related side effects were associated with a single dose of steroid. Recent studies have also shown that Dexamethasone is effective in improving voice outcome and hypocalcaemia in thyroidectomy patients. The investigators aim to study the effect of Dexamethasone in post-operative voice outcome and hypocalcaemia. Objective assessment of the vocal cords during phonation will be performed pre-operative and post-operatively. Serum Calcium level will be monitored.
Key facts
- Study ID
- NCT05732883
- Run by
- Tseung Kwan O Hospital, Hong Kong
- People needed
- 100
- Starts
- 2024-07-01
- Expected to finish
- 2026-09-30
- Last updated by the study team
- 2024-07-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Aged 18 or above
- Patients undergoing total thyroidectomy for benign pathologies
- MNG
- Toxic nodular goitre
- Graves' disease
You may not qualify if…
- Non-communicable patients
- Patients contraindicated for steroid (DM, Hepatitis carrier, Tuberculosis, peptic ulcer disease)
- Patients contraindicated for analgesics including Panadol, Celebrex, Tramadol or Levobupivacaine
- Malignant thyroid disease
- Patients with previous thyroid surgery, or neck surgery
- Pre-existing hoarseness of voice of any cause or pre-existing vocal cord palsy
- Pregnancy / Lactating female patients
- Pre-existing renal disease / autoimmune disease on steroids
- Patients who require steroid cover during operation e.g. hydrocortisone perioperatively
Where it is running
- Department of Otorhinolaryngology, Head and Neck Surgery, United Christian Hospital and Tseung Kwan O Hospital — Hong Kong, Hong Kong (enrolling)
Full record on ClinicalTrials.gov
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