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

July 6, 2024 updated by: YEUNG WING CHI ZENON, Tseung Kwan O Hospital, Hong Kong
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Department of Otorhinolaryngology, Head and Neck Surgery, United Christian Hospital and Tseung Kwan O Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dexamethasone group
One dose of 8mg in 2ml Dexamethasone will be given
Drug: Dexamethasone
Dexamethasone injection
Placebo Comparator: Placebo group
One dose of 2ml 0.9% Normal saline will be given
Drug: Normal saline
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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-op 1 day
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-op 3 months
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
Post-op 6 months
Voice Handicap Index (VHI-10)
Time Frame: Post-op 1 week
Subjective voice assessment consisting of 10 questions. Each question 0-4 score
Post-op 1 week
Voice Handicap Index (VHI-10)
Time Frame: Post-op 3 months
Subjective voice assessment consisting of 10 questions. Each question 0-4 score
Post-op 3 months
Voice Handicap Index (VHI-10)
Time Frame: Post-op 6 months
Subjective voice assessment consisting of 10 questions. Each question 0-4 score
Post-op 6 months
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
Post-op 1 week
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
Post-op 3 months
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
Post-op 6 months
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)
Post-op 1 week
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)
Post-op 3 months
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)
Post-op 6 months
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
Post-op 1 week
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
Post-op 3 months
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
Post-op 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Calcium and Rocaltrol requirement
Time Frame: Post-op 1 week
The required dosage of Calcium Carbonate and Rocaltrol will be documented
Post-op 1 week
Calcium and Rocaltrol requirement
Time Frame: Post-op 3 months
The required dosage of Calcium Carbonate and Rocaltrol will be documented
Post-op 3 months
Calcium and Rocaltrol requirement
Time Frame: Post-op 6 months
The required dosage of Calcium Carbonate and Rocaltrol will be documented
Post-op 6 months
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
Post-op 1 week
Stroboscopic Assessment (Vocal Fold Edge)
Time Frame: Post-op 1 week
Score 1-5 (1 - Smooth and straight; 5 - Rough and irregular)
Post-op 1 week
Stroboscopic Assessment (Vocal Fold Edge)
Time Frame: Post-op 3 months
Score 1-5 (1 - Smooth and straight; 5 - Rough and irregular)
Post-op 3 months
Stroboscopic Assessment (Vocal Fold Edge)
Time Frame: Post-op 6 months
Score 1-5 (1 - Smooth and straight; 5 - Rough and irregular)
Post-op 6 months
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)
Post-op 1 week
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)
Post-op 3 months
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)
Post-op 6 months
Stroboscopic Assessment (Vertical Level of Approximation)
Time Frame: Post-op 1 week
1 - Equal 2 - Right lower 3 - Left lower 4 - Questionable
Post-op 1 week
Stroboscopic Assessment (Vertical Level of Approximation)
Time Frame: Post-op 3 months
1 - Equal 2 - Right lower 3 - Left lower 4 - Questionable
Post-op 3 months
Stroboscopic Assessment (Vertical Level of Approximation)
Time Frame: Post-op 6 months
1 - Equal 2 - Right lower 3 - Left lower 4 - Questionable
Post-op 6 months
Stroboscopic Assessment (Amplitude)
Time Frame: Post-op 1 week
1 - Normal 2 - Slightly decreased 3 - Moderately decreased 4 - Severely decreased 5 - No visible movement
Post-op 1 week
Stroboscopic Assessment (Amplitude)
Time Frame: Post-op 3 months
1 - Normal 2 - Slightly decreased 3 - Moderately decreased 4 - Severely decreased 5 - No visible movement
Post-op 3 months
Stroboscopic Assessment (Amplitude)
Time Frame: Post-op 6 months
1 - Normal 2 - Slightly decreased 3 - Moderately decreased 4 - Severely decreased 5 - No visible movement
Post-op 6 months
Stroboscopic Assessment (Mucosal wave)
Time Frame: Post-op 1 week
1 - Normal 2 - Slightly decreased 3 - Moderately decreased 4 - Severely decreased 5 - Absent
Post-op 1 week
Stroboscopic Assessment (Mucosal wave)
Time Frame: Post-op 3 months
1 - Normal 2 - Slightly decreased 3 - Moderately decreased 4 - Severely decreased 5 - Absent
Post-op 3 months
Stroboscopic Assessment (Mucosal wave)
Time Frame: Post-op 6 months
1 - Normal 2 - Slightly decreased 3 - Moderately decreased 4 - Severely decreased 5 - Absent
Post-op 6 months
Stroboscopic Assessment (Regularity)
Time Frame: Post-op 1 week
1 - Regular 2 - Sometimes irregular 3 - Most irregular 4 - Always irregular
Post-op 1 week
Stroboscopic Assessment (Regularity)
Time Frame: Post-op 3 months
1 - Regular 2 - Sometimes irregular 3 - Most irregular 4 - Always irregular
Post-op 3 months
Stroboscopic Assessment (Regularity)
Time Frame: Post-op 6 months
1 - Regular 2 - Sometimes irregular 3 - Most irregular 4 - Always irregular
Post-op 6 months
Stroboscopic Assessment (Ventricular folds)
Time Frame: Post-op 1 week
Movement - 1.Normal 2.Slight compress 3.Moderate compress 4.Full compress
Post-op 1 week
Stroboscopic Assessment (Ventricular folds)
Time Frame: Post-op 3 months
Movement - 1.Normal 2.Slight compress 3.Moderate compress 4.Full compress
Post-op 3 months
Stroboscopic Assessment (Ventricular folds)
Time Frame: Post-op 6 months
Movement - 1.Normal 2.Slight compress 3.Moderate compress 4.Full compress
Post-op 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tseung Kwan O Hospital, Hong Kong

Collaborators

Chinese University of Hong Kong
United Christian Hospital

Investigators

  • Study Director: Jason YK Chan, MBBS, Department of Otorhinolaryngology, Head and Neck Surgery, The Chinese University of Hong Kong
  • Principal Investigator: Zenon YEUNG, MbChB, Department of Otorhinolaryngology, Head and Neck Surgery, The Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

December 27, 2022

First Submitted That Met QC Criteria

February 8, 2023

First Posted (Actual)

February 17, 2023

Study Record Updates

Last Update Posted (Actual)

July 9, 2024

Last Update Submitted That Met QC Criteria

July 6, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KC/KE-22-0022/FR-4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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