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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2026-09-30

Brief Summary

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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.

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Detailed Description

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This is a multi-specialty, double-blind, randomized, placebo-controlled trial involving the Departments of Surgery in United Christian Hospital, Tseung Kwan O Hospital and Department of Ear, Nose and Throat, United Christian Hospital and Tseung Kwan O Hospital, Kowloon East Cluster. The primary objective is to investigate the effect of Dexamethasone in post-operative voice outcome and hypocalcaemia in total thyroidectomy patients. The secondary outcome aims to investigate the mechanism of voice dysfunction in thyroidectomy patients using objective assessment tools.

To streamline the practice among various departments and to minimize any potential confounders, the peri-operative anaesthetic and post-operative analgesic protocols are standardized. The surgical techniques are also standardized using capsular dissection with positive identification and preservation of the recurrent laryngeal nerve.

Patient's voice and vocal cord mobility will be assessed pre-operatively and post-operatively. Objective assessment of the vocal cord will be carried out using video stroboscopy to document the mobility, waveform and vibration, symmetry and any arytenoid abnormality. Subjective and objective assessment of the voice outcome will be conducted by speech therapists using standardized voice assessment protocol. The trend of hypocalcaemia (Calcium level and parathyroid hormone level) will be monitored and correlated with the use of Dexamethasone. Possible side effect (e.g. wound infection) from the use of Dexamethasone will be analysed

Conditions

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Voice Change Hypocalcemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Multi-specialty, double-blind, randomized, placebo-controlled trial

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Double-blind, randomized, placebo-controlled trial

Study Groups

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Dexamethasone group

One dose of 8mg in 2ml Dexamethasone will be given

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

Dexamethasone injection

Placebo group

One dose of 2ml 0.9% Normal saline will be given

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

Placebo

Interventions

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Dexamethasone

Dexamethasone injection

Intervention Type DRUG

Normal saline

Placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes