Comparison of the Coughing Frequency of Remimazolam Total Intravenous Anesthesia Versus Inhalational Anesthesia : a Single-blinded Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Proportion of patients not coughing during postoperative extubation
研究概览
简要总结
This study is a randomized controlled trial. Adult patients undergoing thyroidectomy under general anesthesia at Severance Hospital and Yonsei Cancer Center are included in tis study. For intervention group, patients receive anesthesia with total intravenous remimazolam, while for control group, patients receive anesthesia with inhalation anesthetic.
The primary end point of the study is to determine whether coughing during endotracheal tube extubation is less when anesthesia is maintained with intravenous remimazolam compared to inhalation anesthetics. The secondary end points are cough score (graded into 4 levels), frequency of reoperation due to postoperative bleeding, These include the frequency of hypertension during the extubation process and whether additional painkillers are used in the recovery room.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged 19 years or older undergoing thyroidectomy under general anesthesia at Severance Hospital Cancer Center.
排除标准
- •Patients with American society of anesthesiologists physical status classification IV or higher.
- •Patients who are hypersensitive to remimazolam or inhalational anesthetic.
- •Patients with structural abnormalities in the upper airway or respiratory diseases.
- •Patients with a history of upper respiratory tract infection within the past 2 weeks.
- •Current smoker
- •Patients who have difficulty reading and understanding the informed consent form
研究组 & 干预措施
Intervention
General anesthesia is maintained with intravenous administration of Byfavo.
干预措施: Total intravenous anesthesia with Byfavo (Drug)
Control
干预措施: Inhalation anesthesia with Sevoflurane (Drug)
结局指标
主要结局
Proportion of patients not coughing during postoperative extubation
时间窗: Until discharge (3days on average)
Proportion of patients not coughing during postoperative extubation
次要结局
- Cough score(Until discharge (3days on average))