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

NCT05732883 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-07-09

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Dexamethasone

Dexamethasone injection

DRUG

Normal saline

Placebo

Sponsors & Collaborators

  • United Christian Hospital

    collaborator OTHER

  • Chinese University of Hong Kong

    collaborator OTHER

  • Tseung Kwan O Hospital, Hong Kong

    lead OTHER

Principal Investigators

  • Jason YK Chan, MBBS · Department of Otorhinolaryngology, Head and Neck Surgery, The Chinese University of Hong Kong

  • Zenon YEUNG, MbChB · Department of Otorhinolaryngology, Head and Neck Surgery, The Chinese University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2026-06-30
Completion
2026-09-30

Countries

  • Hong Kong

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05732883 on ClinicalTrials.gov