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

Hypocalcemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05732883
• Other study ID #: KC/KE-22-0022/FR-4
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: January 1, 2024
• Est. completion date: March 2025

Study information

• Verified date: November 2023
• Source: Tseung Kwan O Hospital, Hong Kong
• Contact: Cherrie Ng
• Phone: +85235051409
• Email: cherrieng[@]ent.cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypocalcemia

Intervention

Drug:
• Dexamethasone
Dexamethasone injection
• Normal saline
Placebo

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Tseung Kwan O Hospital, Hong Kong	Chinese University of Hong Kong, United Christian Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative calcium and parathyroid hormone level on POD1	Serum calcium and parathyroid hormone level will be monitored	Post-op 1 day
Primary	Post-operative calcium and parathyroid hormone level after 3 months post-op	Serum calcium and parathyroid hormone level will be monitored	Post-op 3 months
Primary	Post-operative calcium and parathyroid hormone level after 6 months post-op	Serum calcium and parathyroid hormone level will be monitored	Post-op 6 months
Primary	Voice Handicap Index (VHI-10)	Subjective voice assessment consisting of 10 questions. Each question 0-4 score	Post-op 1 week
Primary	Voice Handicap Index (VHI-10)	Subjective voice assessment consisting of 10 questions. Each question 0-4 score	Post-op 3 months
Primary	Voice Handicap Index (VHI-10)	Subjective voice assessment consisting of 10 questions. Each question 0-4 score	Post-op 6 months
Primary	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	Post-op 1 week
Primary	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	Post-op 3 months
Primary	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	Post-op 6 months
Primary	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)	Post-op 1 week
Primary	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)	Post-op 3 months
Primary	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)	Post-op 6 months
Primary	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	Post-op 1 week
Primary	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	Post-op 3 months
Primary	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	Post-op 6 months
Secondary	Calcium and Rocaltrol requirement	The required dosage of Calcium Carbonate and Rocaltrol will be documented	Post-op 1 week
Secondary	Calcium and Rocaltrol requirement	The required dosage of Calcium Carbonate and Rocaltrol will be documented	Post-op 3 months
Secondary	Calcium and Rocaltrol requirement	The required dosage of Calcium Carbonate and Rocaltrol will be documented	Post-op 6 months
Secondary	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	Post-op 1 week
Secondary	Stroboscopic Assessment (Vocal Fold Edge)	Score 1-5 (1 - Smooth and straight; 5 - Rough and irregular)	Post-op 1 week
Secondary	Stroboscopic Assessment (Vocal Fold Edge)	Score 1-5 (1 - Smooth and straight; 5 - Rough and irregular)	Post-op 3 months
Secondary	Stroboscopic Assessment (Vocal Fold Edge)	Score 1-5 (1 - Smooth and straight; 5 - Rough and irregular)	Post-op 6 months
Secondary	Stroboscopic Assessment (Glottic Closure)	Grading 1-7 (1. Complete 2. Anterior chink 3. Irregular 4. Bowing 5.Posterior chink 6. Hourglass 7 Incomplete)	Post-op 1 week
Secondary	Stroboscopic Assessment (Glottic Closure)	Grading 1-7 (1. Complete 2. Anterior chink 3. Irregular 4. Bowing 5.Posterior chink 6. Hourglass 7 Incomplete)	Post-op 3 months
Secondary	Stroboscopic Assessment (Glottic Closure)	Grading 1-7 (1. Complete 2. Anterior chink 3. Irregular 4. Bowing 5.Posterior chink 6. Hourglass 7 Incomplete)	Post-op 6 months
Secondary	Stroboscopic Assessment (Vertical Level of Approximation)	1 - Equal 2 - Right lower 3 - Left lower 4 - Questionable	Post-op 1 week
Secondary	Stroboscopic Assessment (Vertical Level of Approximation)	1 - Equal 2 - Right lower 3 - Left lower 4 - Questionable	Post-op 3 months
Secondary	Stroboscopic Assessment (Vertical Level of Approximation)	1 - Equal 2 - Right lower 3 - Left lower 4 - Questionable	Post-op 6 months
Secondary	Stroboscopic Assessment (Amplitude)	1 - Normal 2 - Slightly decreased 3 - Moderately decreased 4 - Severely decreased 5 - No visible movement	Post-op 1 week
Secondary	Stroboscopic Assessment (Amplitude)	1 - Normal 2 - Slightly decreased 3 - Moderately decreased 4 - Severely decreased 5 - No visible movement	Post-op 3 months
Secondary	Stroboscopic Assessment (Amplitude)	1 - Normal 2 - Slightly decreased 3 - Moderately decreased 4 - Severely decreased 5 - No visible movement	Post-op 6 months
Secondary	Stroboscopic Assessment (Mucosal wave)	1 - Normal 2 - Slightly decreased 3 - Moderately decreased 4 - Severely decreased 5 - Absent	Post-op 1 week
Secondary	Stroboscopic Assessment (Mucosal wave)	1 - Normal 2 - Slightly decreased 3 - Moderately decreased 4 - Severely decreased 5 - Absent	Post-op 3 months
Secondary	Stroboscopic Assessment (Mucosal wave)	1 - Normal 2 - Slightly decreased 3 - Moderately decreased 4 - Severely decreased 5 - Absent	Post-op 6 months
Secondary	Stroboscopic Assessment (Regularity)	1 - Regular 2 - Sometimes irregular 3 - Most irregular 4 - Always irregular	Post-op 1 week
Secondary	Stroboscopic Assessment (Regularity)	1 - Regular 2 - Sometimes irregular 3 - Most irregular 4 - Always irregular	Post-op 3 months
Secondary	Stroboscopic Assessment (Regularity)	1 - Regular 2 - Sometimes irregular 3 - Most irregular 4 - Always irregular	Post-op 6 months
Secondary	Stroboscopic Assessment (Ventricular folds)	Movement - 1.Normal 2.Slight compress 3.Moderate compress 4.Full compress	Post-op 1 week
Secondary	Stroboscopic Assessment (Ventricular folds)	Movement - 1.Normal 2.Slight compress 3.Moderate compress 4.Full compress	Post-op 3 months
Secondary	Stroboscopic Assessment (Ventricular folds)	Movement - 1.Normal 2.Slight compress 3.Moderate compress 4.Full compress	Post-op 6 months