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

StatusUnknown
PhasePhase 2
Started

Record status This record was last updated July 9, 2024 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.

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Record History

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  1. Minor Changed Registry marked status Unknown (sponsor has not verified the record since Jul 2024); last known: Recruiting
  2. Notable Trial status: Not Yet Recruiting to Recruitingv5 Show 4 more changesShow less
    • Primary completion date: Mar 2025 to Jun 30, 2026
    • Start date changed from estimate of Jan 1, 2024 to Jul 1, 2024
    • Study sites: 0 to 1
    • Study completion date: Mar 2025 to Sep 30, 2026
  3. Notable Start date: Jun 2023 to Jan 1, 2024v4
  4. Notable Start date: Feb 2023 to Jun 2023v3
  5. Minor Collaborators: 6 to 2v2
  6. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05732883
Lead Sponsor Tseung Kwan O Hospital, Hong Kong
Collaborators: United Christian Hospital, Chinese University of Hong Kong
Conditions
(from sponsor)
Voice Change, Hypocalcemia
Related terms Dysphonia, Hoarseness, Hypocalcemia, Hypoparathyroidism, Vocal Cord Paralysis
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov