Voice ChangePhase 2NCT05732883
The Use of Dexamethasone in Total Thyroidectomy to Improve Voice Outcome and Hypocalcaemia
A Phase 2 study testing Dexamethasone and Normal saline in people with Voice Change and Hypocalcemia, run by Tseung Kwan O Hospital, Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Voice Change, Hypocalcemia
- What is being tested?
- Dexamethasone and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jul 2024to 30 Sep 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 or above
- Patients undergoing total thyroidectomy for benign pathologies
- MNG
- Toxic nodular goitre
- Graves' disease
Who cannot join
- 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
Show all 9Show fewer
- Pregnancy / Lactating female patients
- Pre-existing renal disease / autoimmune disease on steroids
- Patients who require steroid cover during operation e.g. hydrocortisone perioperatively
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Department of Otorhinolaryngology, Head and Neck Surgery, United Christian Hospital and Tseung Kwan O Hospital
Hong Kong
Zenon Yeung, MbChB, +852-39495442, dr.zenon.yeung@gmail.com
Thomas Hui, BSc, +852-39493549, hsc526@ha.org.hk
About this study
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.
Read the detailed 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
- Conditions
- Voice Change, Hypocalcemia
- Being tested
- Dexamethasone, Normal saline
- Keywords
- Voice dysfunction, Hoarseness of Voice, Vocal cord palsy, Hypocalcemia, Hypoparathyroidism, Thyroidectomy, Dexamethasone, Steroid
- Medical subject headings
- Dysphonia, Hypocalcemia, Hoarseness, Vocal Cord Paralysis, Hypoparathyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Dexamethasone injection
Normal salineDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone group | Experimental | One dose of 8mg in 2ml Dexamethasone will be given Receives: Drug: Dexamethasone |
| Placebo group | Placebo comparator | One dose of 2ml 0.9% Normal saline will be given Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative calcium and parathyroid hormone level on POD1
Serum calcium and parathyroid hormone level will be monitored
Measured: 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
Measured: 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
Measured: Post-op 6 months
Voice Handicap Index (VHI-10)
Subjective voice assessment consisting of 10 questions. Each question 0-4 score
Measured: Post-op 1 week
Voice Handicap Index (VHI-10)
Subjective voice assessment consisting of 10 questions. Each question 0-4 score
Measured: Post-op 3 months
Voice Handicap Index (VHI-10)
Subjective voice assessment consisting of 10 questions. Each question 0-4 score
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: Post-op 6 months
Secondary outcomes (25)
Calcium and Rocaltrol requirement
The required dosage of Calcium Carbonate and Rocaltrol will be documented
Measured: Post-op 1 week
Calcium and Rocaltrol requirement
The required dosage of Calcium Carbonate and Rocaltrol will be documented
Measured: Post-op 3 months
Calcium and Rocaltrol requirement
The required dosage of Calcium Carbonate and Rocaltrol will be documented
Measured: 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
Measured: Post-op 1 week
Stroboscopic Assessment (Vocal Fold Edge)
Score 1-5 (1 - Smooth and straight; 5 - Rough and irregular)
Measured: Post-op 1 week
Stroboscopic Assessment (Vocal Fold Edge)
Score 1-5 (1 - Smooth and straight; 5 - Rough and irregular)
Measured: Post-op 3 months
Stroboscopic Assessment (Vocal Fold Edge)
Score 1-5 (1 - Smooth and straight; 5 - Rough and irregular)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Post-op 6 months
Stroboscopic Assessment (Vertical Level of Approximation)
1 - Equal 2 - Right lower 3 - Left lower 4 - Questionable
Measured: Post-op 1 week
Stroboscopic Assessment (Vertical Level of Approximation)
1 - Equal 2 - Right lower 3 - Left lower 4 - Questionable
Measured: Post-op 3 months
Stroboscopic Assessment (Vertical Level of Approximation)
1 - Equal 2 - Right lower 3 - Left lower 4 - Questionable
Measured: Post-op 6 months
Stroboscopic Assessment (Amplitude)
1 - Normal 2 - Slightly decreased 3 - Moderately decreased 4 - Severely decreased 5 - No visible movement
Measured: Post-op 1 week
Stroboscopic Assessment (Amplitude)
1 - Normal 2 - Slightly decreased 3 - Moderately decreased 4 - Severely decreased 5 - No visible movement
Measured: Post-op 3 months
Stroboscopic Assessment (Amplitude)
1 - Normal 2 - Slightly decreased 3 - Moderately decreased 4 - Severely decreased 5 - No visible movement
Measured: Post-op 6 months
Stroboscopic Assessment (Mucosal wave)
1 - Normal 2 - Slightly decreased 3 - Moderately decreased 4 - Severely decreased 5 - Absent
Measured: Post-op 1 week
Stroboscopic Assessment (Mucosal wave)
1 - Normal 2 - Slightly decreased 3 - Moderately decreased 4 - Severely decreased 5 - Absent
Measured: Post-op 3 months
Stroboscopic Assessment (Mucosal wave)
1 - Normal 2 - Slightly decreased 3 - Moderately decreased 4 - Severely decreased 5 - Absent
Measured: Post-op 6 months
Stroboscopic Assessment (Regularity)
1 - Regular 2 - Sometimes irregular 3 - Most irregular 4 - Always irregular
Measured: Post-op 1 week
Stroboscopic Assessment (Regularity)
1 - Regular 2 - Sometimes irregular 3 - Most irregular 4 - Always irregular
Measured: Post-op 3 months
Stroboscopic Assessment (Regularity)
1 - Regular 2 - Sometimes irregular 3 - Most irregular 4 - Always irregular
Measured: Post-op 6 months
Stroboscopic Assessment (Ventricular folds)
Movement - 1.Normal 2.Slight compress 3.Moderate compress 4.Full compress
Measured: Post-op 1 week
Stroboscopic Assessment (Ventricular folds)
Movement - 1.Normal 2.Slight compress 3.Moderate compress 4.Full compress
Measured: Post-op 3 months
Stroboscopic Assessment (Ventricular folds)
Movement - 1.Normal 2.Slight compress 3.Moderate compress 4.Full compress
Measured: Post-op 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start1 Jul 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Voice ChangeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multi-specialty, double-blind, randomized, placebo-controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tseung Kwan O Hospital, Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- United Christian Hospital, Chinese University of Hong Kong
- Responsible party
- Principal investigator, YEUNG WING CHI ZENON, Tseung Kwan O Hospital, Hong Kong
- Investigators
- Jason YK Chan, MBBS, Study director, Department of Otorhinolaryngology, Head and Neck Surgery, The Chinese University of Hong KongZenon YEUNG, MbChB, Principal investigator, Department of Otorhinolaryngology, Head and Neck Surgery, The Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05732883
- Sponsor's protocol ID
- KC/KE-22-0022/FR-4
- Status last verified
- Jul 2024
- First submitted
- 27 Dec 2022
- Last updated
- 9 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Dexamethasone in Total Thyroidectomy to Improve Voice Outcome and Hypocalcaemia
- ClinicalTrials.gov ID
- NCT05732883
- Acronym / sponsor ID
- KC/KE-22-0022/FR-4
- Conditions
- Voice Change, Hypocalcemia
- Keywords
- Voice dysfunction, Hoarseness of Voice, Vocal cord palsy, Hypocalcemia, Hypoparathyroidism, Thyroidectomy, Dexamethasone, Steroid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tseung Kwan O Hospital, Hong KongUniversity, hospital or other
- Collaborators
- United Christian Hospital, Chinese University of Hong Kong
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 17 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Multi-specialty, double-blind, randomized, placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone group | Experimental | Drug: DexamethasoneOne dose of 8mg in 2ml Dexamethasone will be given |
| Placebo group | Placebo comparator | Drug: Normal salineOne dose of 2ml 0.9% Normal saline will be given |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18 or above
- Patients undergoing total thyroidectomy for benign pathologies
- MNG
- Toxic nodular goitre
- Graves' disease
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexamethasoneDexamethasone injection | Drug | Dexamethasone group |
| Normal salinePlacebo | Drug | Placebo group |
Primary outcome
Post-operative calcium and parathyroid hormone level on POD1
Time frame: Post-op 1 day
Serum calcium and parathyroid hormone level will be monitored
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
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
Voice Handicap Index (VHI-10)
Time frame: Post-op 1 week
Subjective voice assessment consisting of 10 questions. Each question 0-4 score
Voice Handicap Index (VHI-10)
Time frame: Post-op 3 months
Subjective voice assessment consisting of 10 questions. Each question 0-4 score
Voice Handicap Index (VHI-10)
Time frame: Post-op 6 months
Subjective voice assessment consisting of 10 questions. Each question 0-4 score
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
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
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
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)
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)
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)
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
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
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
25 secondary outcomes
Calcium and Rocaltrol requirement
Time frame: Post-op 1 week
Calcium and Rocaltrol requirement
Time frame: Post-op 3 months
Calcium and Rocaltrol requirement
Time frame: Post-op 6 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: Post-op 1 week
Stroboscopic Assessment (Vocal Fold Edge)
Time frame: Post-op 1 week
Stroboscopic Assessment (Vocal Fold Edge)
Time frame: Post-op 3 months
Stroboscopic Assessment (Vocal Fold Edge)
Time frame: Post-op 6 months
Stroboscopic Assessment (Glottic Closure)
Time frame: Post-op 1 week
Stroboscopic Assessment (Glottic Closure)
Time frame: Post-op 3 months
Stroboscopic Assessment (Glottic Closure)
Time frame: Post-op 6 months
Stroboscopic Assessment (Vertical Level of Approximation)
Time frame: Post-op 1 week
Stroboscopic Assessment (Vertical Level of Approximation)
Time frame: Post-op 3 months
Stroboscopic Assessment (Vertical Level of Approximation)
Time frame: Post-op 6 months
Stroboscopic Assessment (Amplitude)
Time frame: Post-op 1 week
Stroboscopic Assessment (Amplitude)
Time frame: Post-op 3 months
Stroboscopic Assessment (Amplitude)
Time frame: Post-op 6 months
Stroboscopic Assessment (Mucosal wave)
Time frame: Post-op 1 week
Stroboscopic Assessment (Mucosal wave)
Time frame: Post-op 3 months
Stroboscopic Assessment (Mucosal wave)
Time frame: Post-op 6 months
Stroboscopic Assessment (Regularity)
Time frame: Post-op 1 week
Stroboscopic Assessment (Regularity)
Time frame: Post-op 3 months
Stroboscopic Assessment (Regularity)
Time frame: Post-op 6 months
Stroboscopic Assessment (Ventricular folds)
Time frame: Post-op 1 week
Stroboscopic Assessment (Ventricular folds)
Time frame: Post-op 3 months
Stroboscopic Assessment (Ventricular folds)
Time frame: Post-op 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason YK Chan, MBBS study director
Department of Otorhinolaryngology, Head and Neck Surgery, The Chinese University of Hong Kong
Zenon YEUNG, MbChB principal investigator
Department of Otorhinolaryngology, Head and Neck Surgery, The Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dexamethasone and Normal saline in people with Voice Change and Hypocalcemia, run by Tseung Kwan O Hospital, Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cherrie Ng (+85235051409, cherrieng@ent.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative calcium and parathyroid hormone level on POD1 (time frame: Post-op 1 day). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2024.