Antitussive Effect of Single-dose Dexmedetomidine With Low-dose Remifentanil Infusion During Emergence in Adults After Thyroidectomy: Comparison With High-dose Remifentanil Infusion Alone
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Incidence of coughing during emergence from general anesthesia
研究概览
简要总结
After thyroid surgery, the incidence and severity of coughing is important because it may cause serious complications, such as bleeding in the surgical field, laryngospasm, and cardiovascular disturbance. Several studies have shown that the single-dose of dexmedetomidine is effective for reducing cough and agitation during emergence from general anesthesia.
To test the hypothesis that single-dose of dexmedetomidine combined with a low-dose remifentanil infusion during emergence from general anaesthesia could reduce coughing as good as high-dose remifentanil infusion, we will evaluate the efficacy on cough suppression and reduction of side effect of remifentanil using non-inferiority trial.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Thyroid disease undergoing thyroidectomy
- •age 20-65
- •Amerian society of anesthesgiologist class 1 or 2
排除标准
- •chronic cough
- •difficult intubation
- •liver disease
- •uncontrolled hypertension
研究组 & 干预措施
Dexmedetomidine
we administrate the single-dose dexmedetomidine (0.5mcg/kg) with low-dose remifentanil infusion(TCI 1 ng/ml).
干预措施: Dexmedetomidine + Remifentanil-low dose (Drug)
Remifentanil
we administrate the high-dose remifentanil infusion(TCI 2 ng/ml) alone.
干预措施: Remifentanil-high dose (Drug)
结局指标
主要结局
Incidence of coughing during emergence from general anesthesia
时间窗: from 5min before extubation to 5min after extubation
次要结局
- side effect of remifentanil(up to 1 day after surgery)
研究者
Jeong Soo Lee
Clinical Assistant Professor
Yonsei University