NCT05732883 The Use of Dexamethasone in Total Thyroidectomy to Improve Voice Outcome and Hypocalcaemia
| NCT ID | NCT05732883 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Tseung Kwan O Hospital, Hong Kong |
| Condition | Voice Change |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-07-01 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2024-07-01 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: * Aged 18 or above * Patients undergoing total thyroidectomy for benign pathologies * MNG * Toxic nodular goitre * Graves' disease Exclusion Criteria: * 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
Contact & Investigator
Jason YK Chan, MBBS
STUDY DIRECTOR
Department of Otorhinolaryngology, Head and Neck Surgery, The Chinese University of Hong Kong
Frequently Asked Questions
Who can join the NCT05732883 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Voice Change. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05732883 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05732883 currently recruiting?
Yes, NCT05732883 is actively recruiting participants. Contact the research team at cherrieng@ent.cuhk.edu.hk for enrollment information.
Where is the NCT05732883 trial being conducted?
This trial is being conducted at Hong Kong, Hong Kong.
Who is sponsoring the NCT05732883 clinical trial?
NCT05732883 is sponsored by Tseung Kwan O Hospital, Hong Kong. The principal investigator is Jason YK Chan, MBBS at Department of Otorhinolaryngology, Head and Neck Surgery, The Chinese University of Hong Kong. The trial plans to enroll 100 participants.