The Use of Dexamethasone in Total Thyroidectomy to Improve Voice Outcome and Hypocalcaemia
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Post-operative calcium and parathyroid hormone level after 6 months post-op
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Double-blind, randomized, placebo-controlled trial
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18 or above
- •Patients undergoing total thyroidectomy for benign pathologies
- •Toxic nodular goitre
- •Graves' disease
排除标准
- •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
研究组 & 干预措施
Dexamethasone group
One dose of 8mg in 2ml Dexamethasone will be given
干预措施: Dexamethasone (Drug)
Placebo group
One dose of 2ml 0.9% Normal saline will be given
干预措施: Normal saline (Drug)
结局指标
主要结局
Post-operative calcium and parathyroid hormone level after 6 months post-op
时间窗: Post-op 6 months
Serum calcium and parathyroid hormone level will be monitored
Perceptual Evaluation: Cantonese Perceptual Evaluation of Voice (CanPEV)
时间窗: 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-operative calcium and parathyroid hormone level on POD1
时间窗: 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
时间窗: Post-op 3 months
Serum calcium and parathyroid hormone level will be monitored
Voice Handicap Index (VHI-10)
时间窗: Post-op 6 months
Subjective voice assessment consisting of 10 questions. Each question 0-4 score
Acoustic Evaluation
时间窗: 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)
时间窗: 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
次要结局
- Stroboscopic Assessment (Ventricular folds)(Post-op 6 months)
- Stroboscopic Assessment (Glottic Closure)(Post-op 6 months)
- Stroboscopic Assessment (Regularity)(Post-op 6 months)
- Stroboscopic Assessment (Mucosal wave)(Post-op 6 months)
- Stroboscopic Assessment (Vocal Fold Edge)(Post-op 6 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 (Vertical Level of Approximation)(Post-op 6 months)
- Stroboscopic Assessment (Amplitude)(Post-op 6 months)
研究者
YEUNG WING CHI ZENON
Associate Consultant, Department of Otorhinolaryngology, Head and Neck Surgery
Tseung Kwan O Hospital, Hong Kong