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NCT Number: NCT05732883

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

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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Key information

Conditions

Voice Change Calcium Metabolism Disorders Cranial Nerve Diseases Dysphonia Endocrine System Diseases Hoarseness Hypocalcemia Hypoparathyroidism Laryngeal Diseases Metabolic Diseases Nervous System Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Otorhinolaryngologic Diseases Paralysis Parathyroid Diseases Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Vagus Nerve Diseases Vocal Cord Paralysis Voice Disorders Water-Electrolyte Imbalance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone

Drug

Dexamethasone injection

normal saline

Drug

Placebo

Primary outcomes

  1. Post-operative calcium and parathyroid hormone level on POD1

    Time frame: Post-op 1 day

    Serum calcium and parathyroid hormone level will be monitored

  2. Post-operative calcium and parathyroid hormone level after 3 months post-op

    Time frame: Post-op 3 months

    Serum calcium and parathyroid hormone level will be monitored

  3. Post-operative calcium and parathyroid hormone level after 6 months post-op

    Time frame: Post-op 6 months

    Serum calcium and parathyroid hormone level will be monitored

  4. Voice Handicap Index (VHI-10)

    Time frame: Post-op 1 week

    Subjective voice assessment consisting of 10 questions. Each question 0-4 score

  5. Voice Handicap Index (VHI-10)

    Time frame: Post-op 3 months

    Subjective voice assessment consisting of 10 questions. Each question 0-4 score

  6. Voice Handicap Index (VHI-10)

    Time frame: Post-op 6 months

    Subjective voice assessment consisting of 10 questions. Each question 0-4 score

  7. Perceptual Evaluation: Cantonese Perceptual Evaluation of Voice (CanPEV)

    Time frame: Post-op 1 week

    Objective voice assessment consisting of 10 questions. Each question 1-10 score. 1 being normal and 10 being the most severe voice dysfunction

  8. Perceptual Evaluation: Cantonese Perceptual Evaluation of Voice (CanPEV)

    Time frame: Post-op 3 months

    Objective voice assessment consisting of 10 questions. Each question 1-10 score. 1 being normal and 10 being the most severe voice dysfunction

  9. Perceptual Evaluation: Cantonese Perceptual Evaluation of Voice (CanPEV)

    Time frame: Post-op 6 months

    Objective voice assessment consisting of 10 questions. Each question 1-10 score. 1 being normal and 10 being the most severe voice dysfunction

  10. Acoustic Evaluation

    Time frame: Post-op 1 week

    Instruct patient to sustain vowel /a/ and to read aloud the Hong Kong passage at a comfortable pitch and loudness level for about 3-5 seconds. Keep a distance of 15cm from the microphone for recording. Highlight the middle 3 seconds for analysis. To assess the fundamental frequency (Hz) and performance (dB)

  11. Acoustic Evaluation

    Time frame: Post-op 3 months

    Instruct patient to sustain vowel /a/ and to read aloud the Hong Kong passage at a comfortable pitch and loudness level for about 3-5 seconds. Keep a distance of 15cm from the microphone for recording. Highlight the middle 3 seconds for analysis. To assess the fundamental frequency (Hz) and performance (dB)

  12. Acoustic Evaluation

    Time frame: Post-op 6 months

    Instruct patient to sustain vowel /a/ and to read aloud the Hong Kong passage at a comfortable pitch and loudness level for about 3-5 seconds. Keep a distance of 15cm from the microphone for recording. Highlight the middle 3 seconds for analysis. To assess the fundamental frequency (Hz) and performance (dB)

  13. Aerodynamic Evaluation (Maximum sustained phonation)

    Time frame: Post-op 1 week

    Instruct patient to sustain vowel /a/ at a comfortable pitch and loudness level for as long as possible after taking a deep breath. Recorded in seconds

  14. Aerodynamic Evaluation (Maximum sustained phonation)

    Time frame: Post-op 3 months

    Instruct patient to sustain vowel /a/ at a comfortable pitch and loudness level for as long as possible after taking a deep breath. Recorded in seconds

  15. Aerodynamic Evaluation (Maximum sustained phonation)

    Time frame: Post-op 6 months

    Instruct patient to sustain vowel /a/ at a comfortable pitch and loudness level for as long as possible after taking a deep breath. Recorded in seconds

Secondary outcomes

  1. Calcium and Rocaltrol requirement

    Time frame: Post-op 1 week

    The required dosage of Calcium Carbonate and Rocaltrol will be documented

  2. Calcium and Rocaltrol requirement

    Time frame: Post-op 3 months

    The required dosage of Calcium Carbonate and Rocaltrol will be documented

  3. Calcium and Rocaltrol requirement

    Time frame: Post-op 6 months

    The required dosage of Calcium Carbonate and Rocaltrol will be documented

  4. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Time frame: Post-op 1 week

    Number of participants experiencing side effects from Dexamethasone will be documented

  5. Stroboscopic Assessment (Vocal Fold Edge)

    Time frame: Post-op 1 week

    Score 1-5 (1 - Smooth and straight; 5 - Rough and irregular)

  6. Stroboscopic Assessment (Vocal Fold Edge)

    Time frame: Post-op 3 months

    Score 1-5 (1 - Smooth and straight; 5 - Rough and irregular)

  7. Stroboscopic Assessment (Vocal Fold Edge)

    Time frame: Post-op 6 months

    Score 1-5 (1 - Smooth and straight; 5 - Rough and irregular)

  8. Stroboscopic Assessment (Glottic Closure)

    Time frame: Post-op 1 week

    Grading 1-7 (1. Complete 2. Anterior chink 3. Irregular 4. Bowing 5.Posterior chink 6. Hourglass 7 Incomplete)

  9. Stroboscopic Assessment (Glottic Closure)

    Time frame: Post-op 3 months

    Grading 1-7 (1. Complete 2. Anterior chink 3. Irregular 4. Bowing 5.Posterior chink 6. Hourglass 7 Incomplete)

  10. Stroboscopic Assessment (Glottic Closure)

    Time frame: Post-op 6 months

    Grading 1-7 (1. Complete 2. Anterior chink 3. Irregular 4. Bowing 5.Posterior chink 6. Hourglass 7 Incomplete)

  11. Stroboscopic Assessment (Vertical Level of Approximation)

    Time frame: Post-op 1 week

    1 - Equal 2 - Right lower 3 - Left lower 4 - Questionable

  12. Stroboscopic Assessment (Vertical Level of Approximation)

    Time frame: Post-op 3 months

    1 - Equal 2 - Right lower 3 - Left lower 4 - Questionable

  13. Stroboscopic Assessment (Vertical Level of Approximation)

    Time frame: Post-op 6 months

    1 - Equal 2 - Right lower 3 - Left lower 4 - Questionable

  14. Stroboscopic Assessment (Amplitude)

    Time frame: Post-op 1 week

    1 - Normal 2 - Slightly decreased 3 - Moderately decreased 4 - Severely decreased 5 - No visible movement

  15. Stroboscopic Assessment (Amplitude)

    Time frame: Post-op 3 months

    1 - Normal 2 - Slightly decreased 3 - Moderately decreased 4 - Severely decreased 5 - No visible movement

  16. Stroboscopic Assessment (Amplitude)

    Time frame: Post-op 6 months

    1 - Normal 2 - Slightly decreased 3 - Moderately decreased 4 - Severely decreased 5 - No visible movement

  17. Stroboscopic Assessment (Mucosal wave)

    Time frame: Post-op 1 week

    1 - Normal 2 - Slightly decreased 3 - Moderately decreased 4 - Severely decreased 5 - Absent

  18. Stroboscopic Assessment (Mucosal wave)

    Time frame: Post-op 3 months

    1 - Normal 2 - Slightly decreased 3 - Moderately decreased 4 - Severely decreased 5 - Absent

  19. Stroboscopic Assessment (Mucosal wave)

    Time frame: Post-op 6 months

    1 - Normal 2 - Slightly decreased 3 - Moderately decreased 4 - Severely decreased 5 - Absent

  20. Stroboscopic Assessment (Regularity)

    Time frame: Post-op 1 week

    1 - Regular 2 - Sometimes irregular 3 - Most irregular 4 - Always irregular

  21. Stroboscopic Assessment (Regularity)

    Time frame: Post-op 3 months

    1 - Regular 2 - Sometimes irregular 3 - Most irregular 4 - Always irregular

  22. Stroboscopic Assessment (Regularity)

    Time frame: Post-op 6 months

    1 - Regular 2 - Sometimes irregular 3 - Most irregular 4 - Always irregular

  23. Stroboscopic Assessment (Ventricular folds)

    Time frame: Post-op 1 week

    Movement - 1.Normal 2.Slight compress 3.Moderate compress 4.Full compress

  24. Stroboscopic Assessment (Ventricular folds)

    Time frame: Post-op 3 months

    Movement - 1.Normal 2.Slight compress 3.Moderate compress 4.Full compress

  25. Stroboscopic Assessment (Ventricular folds)

    Time frame: Post-op 6 months

    Movement - 1.Normal 2.Slight compress 3.Moderate compress 4.Full compress

Study contacts

Contact information is provided by the study sponsor or research team.

Cherrie Ng

CONTACT

[email protected]

+85235051409

Thomas Hui, BSc

CONTACT

[email protected]

+85239493549

Sponsors and collaborators

Lead sponsor

Tseung Kwan O Hospital, Hong Kong

Other

Collaborators

  • Chinese University of Hong Kong
  • United Christian Hospital

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 17, 2023
Registry last updated
Jul 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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