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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
100
Dexamethasone injection
Placebo
Department of Otorhinolaryngology, Head and Neck Surgery, United Christian Hospital and Tseung Kwan O Hospital
Hong Kong, Hong Kong
RECRUITINGPost-operative calcium and parathyroid hormone level on POD1
Serum calcium and parathyroid hormone level will be monitored
Time frame: Post-op 1 day
Post-operative calcium and parathyroid hormone level after 3 months post-op
Serum calcium and parathyroid hormone level will be monitored
Time frame: Post-op 3 months
Post-operative calcium and parathyroid hormone level after 6 months post-op
Serum calcium and parathyroid hormone level will be monitored
Time frame: Post-op 6 months
Voice Handicap Index (VHI-10)
Subjective voice assessment consisting of 10 questions. Each question 0-4 score
Time frame: Post-op 1 week
Voice Handicap Index (VHI-10)
Subjective voice assessment consisting of 10 questions. Each question 0-4 score
Time frame: Post-op 3 months
Voice Handicap Index (VHI-10)
Subjective voice assessment consisting of 10 questions. Each question 0-4 score
Time frame: Post-op 6 months
Perceptual Evaluation: Cantonese Perceptual Evaluation of Voice (CanPEV)
Objective voice assessment consisting of 10 questions. Each question 1-10 score. 1 being normal and 10 being the most severe voice dysfunction
Time frame: Post-op 1 week
Perceptual Evaluation: Cantonese Perceptual Evaluation of Voice (CanPEV)
Objective voice assessment consisting of 10 questions. Each question 1-10 score. 1 being normal and 10 being the most severe voice dysfunction
Time frame: Post-op 3 months
Perceptual Evaluation: Cantonese Perceptual Evaluation of Voice (CanPEV)
Objective voice assessment consisting of 10 questions. Each question 1-10 score. 1 being normal and 10 being the most severe voice dysfunction
Time frame: Post-op 6 months
Acoustic Evaluation
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)
Time frame: Post-op 1 week
Acoustic Evaluation
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)
Time frame: Post-op 3 months
Acoustic Evaluation
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)
Time frame: Post-op 6 months
Aerodynamic Evaluation (Maximum sustained phonation)
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
Time frame: Post-op 1 week
Aerodynamic Evaluation (Maximum sustained phonation)
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
Time frame: Post-op 3 months
Aerodynamic Evaluation (Maximum sustained phonation)
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
Time frame: Post-op 6 months
Calcium and Rocaltrol requirement
The required dosage of Calcium Carbonate and Rocaltrol will be documented
Time frame: Post-op 1 week
Calcium and Rocaltrol requirement
The required dosage of Calcium Carbonate and Rocaltrol will be documented
Time frame: Post-op 3 months
Calcium and Rocaltrol requirement
The required dosage of Calcium Carbonate and Rocaltrol will be documented
Time frame: Post-op 6 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Number of participants experiencing side effects from Dexamethasone will be documented
Time frame: Post-op 1 week
Stroboscopic Assessment (Vocal Fold Edge)
Score 1-5 (1 - Smooth and straight; 5 - Rough and irregular)
Time frame: Post-op 1 week
Stroboscopic Assessment (Vocal Fold Edge)
Score 1-5 (1 - Smooth and straight; 5 - Rough and irregular)
Time frame: Post-op 3 months
Stroboscopic Assessment (Vocal Fold Edge)
Score 1-5 (1 - Smooth and straight; 5 - Rough and irregular)
Time frame: Post-op 6 months
Stroboscopic Assessment (Glottic Closure)
Grading 1-7 (1. Complete 2. Anterior chink 3. Irregular 4. Bowing 5.Posterior chink 6. Hourglass 7 Incomplete)
Time frame: Post-op 1 week
Stroboscopic Assessment (Glottic Closure)
Grading 1-7 (1. Complete 2. Anterior chink 3. Irregular 4. Bowing 5.Posterior chink 6. Hourglass 7 Incomplete)
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Time frame: Post-op 3 months
Stroboscopic Assessment (Glottic Closure)
Grading 1-7 (1. Complete 2. Anterior chink 3. Irregular 4. Bowing 5.Posterior chink 6. Hourglass 7 Incomplete)
Time frame: Post-op 6 months
Stroboscopic Assessment (Vertical Level of Approximation)
1 - Equal 2 - Right lower 3 - Left lower 4 - Questionable
Time frame: Post-op 1 week
Stroboscopic Assessment (Vertical Level of Approximation)
1 - Equal 2 - Right lower 3 - Left lower 4 - Questionable
Time frame: Post-op 3 months
Stroboscopic Assessment (Vertical Level of Approximation)
1 - Equal 2 - Right lower 3 - Left lower 4 - Questionable
Time frame: Post-op 6 months
Stroboscopic Assessment (Amplitude)
1 - Normal 2 - Slightly decreased 3 - Moderately decreased 4 - Severely decreased 5 - No visible movement
Time frame: Post-op 1 week
Stroboscopic Assessment (Amplitude)
1 - Normal 2 - Slightly decreased 3 - Moderately decreased 4 - Severely decreased 5 - No visible movement
Time frame: Post-op 3 months
Stroboscopic Assessment (Amplitude)
1 - Normal 2 - Slightly decreased 3 - Moderately decreased 4 - Severely decreased 5 - No visible movement
Time frame: Post-op 6 months
Stroboscopic Assessment (Mucosal wave)
1 - Normal 2 - Slightly decreased 3 - Moderately decreased 4 - Severely decreased 5 - Absent
Time frame: Post-op 1 week
Stroboscopic Assessment (Mucosal wave)
1 - Normal 2 - Slightly decreased 3 - Moderately decreased 4 - Severely decreased 5 - Absent
Time frame: Post-op 3 months
Stroboscopic Assessment (Mucosal wave)
1 - Normal 2 - Slightly decreased 3 - Moderately decreased 4 - Severely decreased 5 - Absent
Time frame: Post-op 6 months
Stroboscopic Assessment (Regularity)
1 - Regular 2 - Sometimes irregular 3 - Most irregular 4 - Always irregular
Time frame: Post-op 1 week
Stroboscopic Assessment (Regularity)
1 - Regular 2 - Sometimes irregular 3 - Most irregular 4 - Always irregular
Time frame: Post-op 3 months
Stroboscopic Assessment (Regularity)
1 - Regular 2 - Sometimes irregular 3 - Most irregular 4 - Always irregular
Time frame: Post-op 6 months
Stroboscopic Assessment (Ventricular folds)
Movement - 1.Normal 2.Slight compress 3.Moderate compress 4.Full compress
Time frame: Post-op 1 week
Stroboscopic Assessment (Ventricular folds)
Movement - 1.Normal 2.Slight compress 3.Moderate compress 4.Full compress
Time frame: Post-op 3 months
Stroboscopic Assessment (Ventricular folds)
Movement - 1.Normal 2.Slight compress 3.Moderate compress 4.Full compress
Time frame: Post-op 6 months