About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Aged 18 or above
Patients undergoing total thyroidectomy for benign pathologies
MNG
Toxic nodular goitre
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Dexamethasone
DrugDexamethasone injection
Normal saline
DrugPlacebo
Treatment groups
Trial outcomes
Primary outcomes
Post-operative calcium and parathyroid hormone level on POD1
Serum calcium and parathyroid hormone level will be monitored
Post-operative calcium and parathyroid hormone level after 3 months post-op
Serum calcium and parathyroid hormone level will be monitored
Post-operative calcium and parathyroid hormone level after 6 months post-op
Serum calcium and parathyroid hormone level will be monitored
Voice Handicap Index (VHI-10)
Subjective voice assessment consisting of 10 questions. Each question 0-4 score
Secondary outcomes
Calcium and Rocaltrol requirement
The required dosage of Calcium Carbonate and Rocaltrol will be documented
Calcium and Rocaltrol requirement
The required dosage of Calcium Carbonate and Rocaltrol will be documented
Calcium and Rocaltrol requirement
The required dosage of Calcium Carbonate and Rocaltrol will be documented
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Number of participants experiencing side effects from Dexamethasone will be documented
Sponsors and contacts
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Tseung Kwan O Hospital, Hong Kong
Lead sponsor
United Christian Hospital
Collaborator
Chinese University of Hong Kong
Collaborator