Comparison of Sufentanil, Fentanyl and Remifentanil in Combination With Midazolam During Bronchoscopy Under Conscious Sedation: A Randomized Double-blind Prospective Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Dosage of midazolam
研究概览
简要总结
The best opioid for bronchoscopy is still unclear.This randomized double-blind prospective study was conducted on a total of 60 patients who were randomly allocated into 3 groups: Group S received sufentanil 0.1 mcg/kg, Group F received fentanyl 1 mcg/kg and Group R received remifentanil target-controlled infusion with effect-site target concentration of 1ng/ml. Patients in all groups received midazolam to achieve moderate levels of sedation as assessed by the Narcotrend (NT; between B1 and C2). Adverse events, patient tolerance and physician satisfaction were analized.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA grade I-II
排除标准
- •psychological disorders
- •SpO2<90% in ambient air
- •hypersensitivity or allergy to anaesthetic drugs or benzodiazepine
- •severe chronic obstructive pulmonary disease (forced expiratory volume in 1 s ,50% of predicted value, requirement for oxygen therapy)
- •unstable haemodynamic status
- •habitual alcohol consumption
- •asthmatic patients
研究组 & 干预措施
Sufentanil
Group S received sufentanil 0.1 mcg/kg and midazolam to achieve moderate levels of sedation as assessed by the Narcotrend (NT; between B1 and C2).
干预措施: Sufentanil (Drug)
Sufentanil
Group S received sufentanil 0.1 mcg/kg and midazolam to achieve moderate levels of sedation as assessed by the Narcotrend (NT; between B1 and C2).
干预措施: Midazolam (Drug)
Fentanyl
Group F received fentanyl 1 mcg/kg and midazolam to achieve moderate levels of sedation as assessed by the Narcotrend (NT; between B1 and C2).
干预措施: Fentanyl (Drug)
Fentanyl
Group F received fentanyl 1 mcg/kg and midazolam to achieve moderate levels of sedation as assessed by the Narcotrend (NT; between B1 and C2).
干预措施: Midazolam (Drug)
Remifentanil
Group R received remifentanil target-controlled infusion with effect-site target concentration of 1ng/ml and midazolam to achieve moderate levels of sedation as assessed by the Narcotrend (NT; between B1 and C2).
干预措施: Remifentanil (Drug)
Remifentanil
Group R received remifentanil target-controlled infusion with effect-site target concentration of 1ng/ml and midazolam to achieve moderate levels of sedation as assessed by the Narcotrend (NT; between B1 and C2).
干预措施: Midazolam (Drug)
结局指标
主要结局
Dosage of midazolam
时间窗: during the procedure
Dosage of midazolam applied
次要结局
- rate of oxygen desaturation(during the procedure)
- severity of cough(during the procedure)
- patient's global tolerance assessed by operator(30minutes after bronchoscopy)
- patient's subjective tolerance(30minutes after bronchoscopy)
研究者
ShiYue Li
Clinical Professor
Guangzhou Institute of Respiratory Disease