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

NCT05732883 | Recruiting Phase 2 DMC

• 1 other identifier: KC/KE-22-0022/FR-4
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Voice Change; Hypocalcemia

Keywords

Voice dysfunction; Hoarseness of Voice; Vocal cord palsy; Hypocalcemia; Hypoparathyroidism; Thyroidectomy; Dexamethasone; Steroid

Outcome Measures

Primary Outcomes (15)

• Post-operative calcium and parathyroid hormone level on POD1

  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

  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

  Serum calcium and parathyroid hormone level will be monitored

  Post-op 6 months

• Voice Handicap Index (VHI-10)

  Subjective voice assessment consisting of 10 questions. Each question 0-4 score

  Post-op 1 week

• Voice Handicap Index (VHI-10)

  Subjective voice assessment consisting of 10 questions. Each question 0-4 score

  Post-op 3 months

• Voice Handicap Index (VHI-10)

  Subjective voice assessment consisting of 10 questions. Each question 0-4 score

  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

  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

  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

  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)

  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)

  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)

  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

  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

  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

  Post-op 6 months

Secondary Outcomes (25)

• Calcium and Rocaltrol requirement

  Post-op 1 week

• Calcium and Rocaltrol requirement

  Post-op 3 months

• Calcium and Rocaltrol requirement

  Post-op 6 months

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  Post-op 1 week

• Stroboscopic Assessment (Vocal Fold Edge)

  Post-op 1 week

Study Arms (2)

Dexamethasone group

EXPERIMENTAL

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

Drug: Dexamethasone

Placebo group

PLACEBO COMPARATOR

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

Drug: Normal saline

Interventions

Dexamethasone DRUG

Dexamethasone injection

Dexamethasone group

Normal saline DRUG

Placebo

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 or above
• Patients undergoing total thyroidectomy for benign pathologies
• MNG
• Toxic nodular goitre
• Graves' disease

You may not qualify if:

• 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

Sponsors & Collaborators

• Tseung Kwan O Hospital, Hong Kong: lead
• United Christian Hospital: collaborator
• Chinese University of Hong Kong: collaborator

Study Sites (1)

Department of Otorhinolaryngology, Head and Neck Surgery, United Christian Hospital and Tseung Kwan O Hospital

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Dysphonia; Hypocalcemia; Hoarseness; Vocal Cord Paralysis; Hypoparathyroidism

Interventions

Dexamethasone; Saline Solution

Condition Hierarchy (Ancestors)

Voice Disorders; Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Water-Electrolyte Imbalance; Respiration Disorders; Signs and Symptoms, Respiratory; Vagus Nerve Diseases; Cranial Nerve Diseases; Paralysis; Parathyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Jason YK Chan, MBBS

  Department of Otorhinolaryngology, Head and Neck Surgery, The Chinese University of Hong Kong

  STUDY DIRECTOR

• Zenon YEUNG, MbChB

  Department of Otorhinolaryngology, Head and Neck Surgery, The Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cherrie Ng

CONTACT

+85235051409; cherrieng@ent.cuhk.edu.hk

Thomas Hui, BSc

CONTACT

+85239493549; hsc526@ha.org.hk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double-blind, randomized, placebo-controlled trial
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Consultant, Department of Otorhinolaryngology, Head and Neck Surgery

Model Details: Multi-specialty, double-blind, randomized, placebo-controlled trial

Study Record Dates

• First Submitted: December 27, 2022
• First Posted: February 17, 2023
• Study Start: July 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: July 9, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)