Intra-operative Steroid Irrigation for Reducing Recurrent Laryngeal Nerve Palsy Post-thyroidectomy
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Post thyroidectomy vocal cord assessment will be performed by otolaryngologist within 3 weeks after surgery by using indirect larygoscopy, to look for any vocal cord palsy
研究概览
简要总结
The main aim of this study is to elucidate whether the topical irrigation of steroid during thyroid surgery can reduce the rate of recurrent laryngeal nerve palsy as majority of nerve dysfunction was due to neuropraxia to axonotmesis.
Intra-operatively, all participants recruited must have the recurrent laryngeal nerve identify and confirm with Intraoperative Nerve Monitoring (IONM) device.
After removal of thyroid gland, 8mg of dexamethasone will be diluted in 100cc of irrigation water and irrigate the operative field for 1 minute for the intervention group.
However for the placebo group, they will received water irrigation over the operative field only which is the current standard of practice at the moment.
Both the otolaryngologist and patient are blinded throughout the whole study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The target population are patients who scheduled for thyroidectomy (include both total or hemithyroidectomy) under UMMC
- •Age between 18 years old till 80 years old
排除标准
- •Vocal cord paresis before surgery
- •No consent
- •Allergy towards dexamethasone
- •Surgery involved neck dissection
- •Retrosternal goitre
研究组 & 干预措施
Intra-operative Water for Injection for Irrigation for Post-thyroidectomy
For the placebo group, they will received water irrigation over the operative field only which is the current standard of practice at the moment.
干预措施: Water for injection (Drug)
Intra-operative Dexamethasone Irrigation for Reducing Recurrent Laryngeal Nerve Palsy
Intra-operatively, all participants recruited must have the recurrent laryngeal nerve identify and confirm with Intraoperative Nerve Monitoring (IONM) device.
After removal of thyroid gland, 8mg of dexamethasone will be diluted in 100cc of irrigation water and irrigate the operative field for 1 minute for the intervention group.
干预措施: Dexametasone (Drug)
结局指标
主要结局
Post thyroidectomy vocal cord assessment will be performed by otolaryngologist within 3 weeks after surgery by using indirect larygoscopy, to look for any vocal cord palsy
时间窗: Three week post surgery
if both the vocal cord mobile equally with no phonation gap, indicated no vocal cord palsy if any of the vocal cord paralysed with phonation gap, indicated vocal cord palsy
次要结局
未报告次要终点
研究者
Chua Jenna
Master Student
University of Malaya