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

Primary Purpose

Voice Change, Hypocalcemia

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Dexamethasone
Normal saline
Sponsored by
Tseung Kwan O Hospital, Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Voice Change focused on measuring Voice dysfunction, Hoarseness of Voice, Vocal cord palsy, Hypocalcemia, Hypoparathyroidism, Thyroidectomy, Dexamethasone, Steroid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Dexamethasone group

    Placebo group

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Post-operative calcium and parathyroid hormone level on POD1
    Serum calcium and parathyroid hormone level will be monitored
    Post-operative calcium and parathyroid hormone level after 3 months post-op
    Serum calcium and parathyroid hormone level will be monitored
    Post-operative calcium and parathyroid hormone level after 6 months post-op
    Serum calcium and parathyroid hormone level will be monitored
    Voice Handicap Index (VHI-10)
    Subjective voice assessment consisting of 10 questions. Each question 0-4 score
    Voice Handicap Index (VHI-10)
    Subjective voice assessment consisting of 10 questions. Each question 0-4 score
    Voice Handicap Index (VHI-10)
    Subjective voice assessment consisting of 10 questions. Each question 0-4 score
    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
    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
    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
    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)
    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)
    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)
    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
    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
    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

    Secondary Outcome Measures

    Calcium and Rocaltrol requirement
    The required dosage of Calcium Carbonate and Rocaltrol will be documented
    Calcium and Rocaltrol requirement
    The required dosage of Calcium Carbonate and Rocaltrol will be documented
    Calcium and Rocaltrol requirement
    The required dosage of Calcium Carbonate and Rocaltrol will be documented
    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
    Stroboscopic Assessment (Vocal Fold Edge)
    Score 1-5 (1 - Smooth and straight; 5 - Rough and irregular)
    Stroboscopic Assessment (Vocal Fold Edge)
    Score 1-5 (1 - Smooth and straight; 5 - Rough and irregular)
    Stroboscopic Assessment (Vocal Fold Edge)
    Score 1-5 (1 - Smooth and straight; 5 - Rough and irregular)
    Stroboscopic Assessment (Glottic Closure)
    Grading 1-7 (1. Complete 2. Anterior chink 3. Irregular 4. Bowing 5.Posterior chink 6. Hourglass 7 Incomplete)
    Stroboscopic Assessment (Glottic Closure)
    Grading 1-7 (1. Complete 2. Anterior chink 3. Irregular 4. Bowing 5.Posterior chink 6. Hourglass 7 Incomplete)
    Stroboscopic Assessment (Glottic Closure)
    Grading 1-7 (1. Complete 2. Anterior chink 3. Irregular 4. Bowing 5.Posterior chink 6. Hourglass 7 Incomplete)
    Stroboscopic Assessment (Vertical Level of Approximation)
    1 - Equal 2 - Right lower 3 - Left lower 4 - Questionable
    Stroboscopic Assessment (Vertical Level of Approximation)
    1 - Equal 2 - Right lower 3 - Left lower 4 - Questionable
    Stroboscopic Assessment (Vertical Level of Approximation)
    1 - Equal 2 - Right lower 3 - Left lower 4 - Questionable
    Stroboscopic Assessment (Amplitude)
    1 - Normal 2 - Slightly decreased 3 - Moderately decreased 4 - Severely decreased 5 - No visible movement
    Stroboscopic Assessment (Amplitude)
    1 - Normal 2 - Slightly decreased 3 - Moderately decreased 4 - Severely decreased 5 - No visible movement
    Stroboscopic Assessment (Amplitude)
    1 - Normal 2 - Slightly decreased 3 - Moderately decreased 4 - Severely decreased 5 - No visible movement
    Stroboscopic Assessment (Mucosal wave)
    1 - Normal 2 - Slightly decreased 3 - Moderately decreased 4 - Severely decreased 5 - Absent
    Stroboscopic Assessment (Mucosal wave)
    1 - Normal 2 - Slightly decreased 3 - Moderately decreased 4 - Severely decreased 5 - Absent
    Stroboscopic Assessment (Mucosal wave)
    1 - Normal 2 - Slightly decreased 3 - Moderately decreased 4 - Severely decreased 5 - Absent
    Stroboscopic Assessment (Regularity)
    1 - Regular 2 - Sometimes irregular 3 - Most irregular 4 - Always irregular
    Stroboscopic Assessment (Regularity)
    1 - Regular 2 - Sometimes irregular 3 - Most irregular 4 - Always irregular
    Stroboscopic Assessment (Regularity)
    1 - Regular 2 - Sometimes irregular 3 - Most irregular 4 - Always irregular
    Stroboscopic Assessment (Ventricular folds)
    Movement - 1.Normal 2.Slight compress 3.Moderate compress 4.Full compress
    Stroboscopic Assessment (Ventricular folds)
    Movement - 1.Normal 2.Slight compress 3.Moderate compress 4.Full compress
    Stroboscopic Assessment (Ventricular folds)
    Movement - 1.Normal 2.Slight compress 3.Moderate compress 4.Full compress

    Full Information

    First Posted
    December 27, 2022
    Last Updated
    April 13, 2023
    Sponsor
    Tseung Kwan O Hospital, Hong Kong
    Collaborators
    United Christian Hospital, Chinese University of Hong Kong
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05732883
    Brief Title
    The Use of Dexamethasone in Total Thyroidectomy to Improve Voice Outcome and Hypocalcaemia
    Official Title
    The Use of Dexamethasone in Total Thyroidectomy to Improve Voice Outcome and Hypocalcaemia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 2023 (Anticipated)
    Primary Completion Date
    March 2025 (Anticipated)
    Study Completion Date
    March 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Tseung Kwan O Hospital, Hong Kong
    Collaborators
    United Christian Hospital, Chinese University of Hong Kong

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Voice Change, Hypocalcemia
    Keywords
    Voice dysfunction, Hoarseness of Voice, Vocal cord palsy, Hypocalcemia, Hypoparathyroidism, Thyroidectomy, Dexamethasone, Steroid

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Model Description
    Multi-specialty, double-blind, randomized, placebo-controlled trial
    Masking
    ParticipantCare ProviderInvestigator
    Masking Description
    Double-blind, randomized, placebo-controlled trial
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Dexamethasone group
    Arm Type
    Experimental
    Arm Description
    One dose of 8mg in 2ml Dexamethasone will be given
    Arm Title
    Placebo group
    Arm Type
    Placebo Comparator
    Arm Description
    One dose of 2ml 0.9% Normal saline will be given
    Intervention Type
    Drug
    Intervention Name(s)
    Dexamethasone
    Intervention Description
    Dexamethasone injection
    Intervention Type
    Drug
    Intervention Name(s)
    Normal saline
    Intervention Description
    Placebo
    Primary Outcome Measure Information:
    Title
    Post-operative calcium and parathyroid hormone level on POD1
    Description
    Serum calcium and parathyroid hormone level will be monitored
    Time Frame
    Post-op 1 day
    Title
    Post-operative calcium and parathyroid hormone level after 3 months post-op
    Description
    Serum calcium and parathyroid hormone level will be monitored
    Time Frame
    Post-op 3 months
    Title
    Post-operative calcium and parathyroid hormone level after 6 months post-op
    Description
    Serum calcium and parathyroid hormone level will be monitored
    Time Frame
    Post-op 6 months
    Title
    Voice Handicap Index (VHI-10)
    Description
    Subjective voice assessment consisting of 10 questions. Each question 0-4 score
    Time Frame
    Post-op 1 week
    Title
    Voice Handicap Index (VHI-10)
    Description
    Subjective voice assessment consisting of 10 questions. Each question 0-4 score
    Time Frame
    Post-op 3 months
    Title
    Voice Handicap Index (VHI-10)
    Description
    Subjective voice assessment consisting of 10 questions. Each question 0-4 score
    Time Frame
    Post-op 6 months
    Title
    Perceptual Evaluation: Cantonese Perceptual Evaluation of Voice (CanPEV)
    Description
    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
    Title
    Perceptual Evaluation: Cantonese Perceptual Evaluation of Voice (CanPEV)
    Description
    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
    Title
    Perceptual Evaluation: Cantonese Perceptual Evaluation of Voice (CanPEV)
    Description
    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
    Title
    Acoustic Evaluation
    Description
    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
    Title
    Acoustic Evaluation
    Description
    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
    Title
    Acoustic Evaluation
    Description
    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
    Title
    Aerodynamic Evaluation (Maximum sustained phonation)
    Description
    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
    Title
    Aerodynamic Evaluation (Maximum sustained phonation)
    Description
    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
    Title
    Aerodynamic Evaluation (Maximum sustained phonation)
    Description
    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
    Secondary Outcome Measure Information:
    Title
    Calcium and Rocaltrol requirement
    Description
    The required dosage of Calcium Carbonate and Rocaltrol will be documented
    Time Frame
    Post-op 1 week
    Title
    Calcium and Rocaltrol requirement
    Description
    The required dosage of Calcium Carbonate and Rocaltrol will be documented
    Time Frame
    Post-op 3 months
    Title
    Calcium and Rocaltrol requirement
    Description
    The required dosage of Calcium Carbonate and Rocaltrol will be documented
    Time Frame
    Post-op 6 months
    Title
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
    Description
    Number of participants experiencing side effects from Dexamethasone will be documented
    Time Frame
    Post-op 1 week
    Title
    Stroboscopic Assessment (Vocal Fold Edge)
    Description
    Score 1-5 (1 - Smooth and straight; 5 - Rough and irregular)
    Time Frame
    Post-op 1 week
    Title
    Stroboscopic Assessment (Vocal Fold Edge)
    Description
    Score 1-5 (1 - Smooth and straight; 5 - Rough and irregular)
    Time Frame
    Post-op 3 months
    Title
    Stroboscopic Assessment (Vocal Fold Edge)
    Description
    Score 1-5 (1 - Smooth and straight; 5 - Rough and irregular)
    Time Frame
    Post-op 6 months
    Title
    Stroboscopic Assessment (Glottic Closure)
    Description
    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
    Title
    Stroboscopic Assessment (Glottic Closure)
    Description
    Grading 1-7 (1. Complete 2. Anterior chink 3. Irregular 4. Bowing 5.Posterior chink 6. Hourglass 7 Incomplete)
    Time Frame
    Post-op 3 months
    Title
    Stroboscopic Assessment (Glottic Closure)
    Description
    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
    Title
    Stroboscopic Assessment (Vertical Level of Approximation)
    Description
    1 - Equal 2 - Right lower 3 - Left lower 4 - Questionable
    Time Frame
    Post-op 1 week
    Title
    Stroboscopic Assessment (Vertical Level of Approximation)
    Description
    1 - Equal 2 - Right lower 3 - Left lower 4 - Questionable
    Time Frame
    Post-op 3 months
    Title
    Stroboscopic Assessment (Vertical Level of Approximation)
    Description
    1 - Equal 2 - Right lower 3 - Left lower 4 - Questionable
    Time Frame
    Post-op 6 months
    Title
    Stroboscopic Assessment (Amplitude)
    Description
    1 - Normal 2 - Slightly decreased 3 - Moderately decreased 4 - Severely decreased 5 - No visible movement
    Time Frame
    Post-op 1 week
    Title
    Stroboscopic Assessment (Amplitude)
    Description
    1 - Normal 2 - Slightly decreased 3 - Moderately decreased 4 - Severely decreased 5 - No visible movement
    Time Frame
    Post-op 3 months
    Title
    Stroboscopic Assessment (Amplitude)
    Description
    1 - Normal 2 - Slightly decreased 3 - Moderately decreased 4 - Severely decreased 5 - No visible movement
    Time Frame
    Post-op 6 months
    Title
    Stroboscopic Assessment (Mucosal wave)
    Description
    1 - Normal 2 - Slightly decreased 3 - Moderately decreased 4 - Severely decreased 5 - Absent
    Time Frame
    Post-op 1 week
    Title
    Stroboscopic Assessment (Mucosal wave)
    Description
    1 - Normal 2 - Slightly decreased 3 - Moderately decreased 4 - Severely decreased 5 - Absent
    Time Frame
    Post-op 3 months
    Title
    Stroboscopic Assessment (Mucosal wave)
    Description
    1 - Normal 2 - Slightly decreased 3 - Moderately decreased 4 - Severely decreased 5 - Absent
    Time Frame
    Post-op 6 months
    Title
    Stroboscopic Assessment (Regularity)
    Description
    1 - Regular 2 - Sometimes irregular 3 - Most irregular 4 - Always irregular
    Time Frame
    Post-op 1 week
    Title
    Stroboscopic Assessment (Regularity)
    Description
    1 - Regular 2 - Sometimes irregular 3 - Most irregular 4 - Always irregular
    Time Frame
    Post-op 3 months
    Title
    Stroboscopic Assessment (Regularity)
    Description
    1 - Regular 2 - Sometimes irregular 3 - Most irregular 4 - Always irregular
    Time Frame
    Post-op 6 months
    Title
    Stroboscopic Assessment (Ventricular folds)
    Description
    Movement - 1.Normal 2.Slight compress 3.Moderate compress 4.Full compress
    Time Frame
    Post-op 1 week
    Title
    Stroboscopic Assessment (Ventricular folds)
    Description
    Movement - 1.Normal 2.Slight compress 3.Moderate compress 4.Full compress
    Time Frame
    Post-op 3 months
    Title
    Stroboscopic Assessment (Ventricular folds)
    Description
    Movement - 1.Normal 2.Slight compress 3.Moderate compress 4.Full compress
    Time Frame
    Post-op 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Cherrie Ng
    Phone
    +85235051409
    Email
    cherrieng@ent.cuhk.edu.hk
    First Name & Middle Initial & Last Name or Official Title & Degree
    Thomas Hui, BSc
    Phone
    +85239493549
    Email
    hsc526@ha.org.hk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jason YK Chan, MBBS
    Organizational Affiliation
    Department of Otorhinolaryngology, Head and Neck Surgery, The Chinese University of Hong Kong
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Zenon YEUNG, MbChB
    Organizational Affiliation
    Department of Otorhinolaryngology, Head and Neck Surgery, The Chinese University of Hong Kong
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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