Comparison of Sedation and General Anesthesia With Laryngeal Mask in Therapeutic Bronchoscopy
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Recovery time
研究概览
简要总结
Therapeutic bronchoscopy is a common procedure to treat respiratory diseases. The procedure includes stent implantation, bronchus dilation, electronic incision, laser therapy, and so on. Most of these procedures are painful and require general anesthesia. Conventionally, the general anesthesia for therapeutic bronchoscopy was performed using laryngeal mask. But in the previous experiences, the investigators found that sedation with dexmedetomidine and remifentanil was as effect as laryngeal mask anesthesia. The present study was performed to compare the two approach for sedation or anesthesia in therapeutic bronchoscopy.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled for flexible therapeutic bronchoscopy
- •Adult patients aged 18 to 65 years
- •American Society of Anesthesiologists (ASA) Physical Status Classification I-II
- •BMI 18.5-25kg/m2
- •Subjects provide informed consent
排除标准
- •Severe airway obstruction
- •Coagulation disorder
- •Repeat bronchoscopy (more than 3 times)
- •Severe liver and renal dysfunction
- •Cardiovascular and cerebrovascular diseases
- •Pregnancy
- •Chronic opioid user
- •Drug abusers or addicts
研究组 & 干预措施
Group DR
Patients sedated with dexmedetomidine and remifentanil.
干预措施: Dexmedetomidine (Drug)
Group DR
Patients sedated with dexmedetomidine and remifentanil.
干预措施: Remifentanil (Drug)
Group LMA
General anesthesia was applied using laryngeal mask.
干预措施: Laryngeal mask (Device)
结局指标
主要结局
Recovery time
时间窗: After termination of the sedation medication, assessed up to 3 hours
Duration of the recovery from sedation
次要结局
- Prevalence of the side effects of respiratory and circulatory system(Across the sedation or anesthesia, assessed up to 3 hours)
- Satisfaction score of the patients and bronchoscopists(Across the procedure, assessed up to 3 hours)
- The numbers of the times of body movement(From the completion of local anesthesia with lidocaine to the completion of bronchoscopy procedure, assessed up to 3 hours)
- Cost of anesthesia or sedation(Across the sedation or anesthesia, assessed up to 3 hours)
- Cough score(From the completion of local anesthesia with lidocaine to the completion of bronchoscopy procedure, assessed up to 3 hours)
研究者
Jia-feng Wang
Clinical Professor
Changhai Hospital