Narcotrend Versus Bispectral Index Monitoring During Sufentanil-Midazolam Anesthesia for Bronchoscopy Under Conscious Sedation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Dosage of Midazoam
研究概览
简要总结
This study was aimed to determine whether narcotrend monitoring was better than bispectral index monitoring during sufentanil-midazolam anesthesia for bronchoscopy under conscious sedation. Patients were randomised to receive Narcotrend, Bispectral Index(BIS) monitoring or without monitoring. Midazolam was given by non-anaesthetist physicians to achieve moderate levels of sedation as assessed by the narcotrend index (NI; B and C) or bispectral index (BIS; between 70 and 85) or according to patient's tolerance assessed by physician . The primary end-point was dosage of midazolam. Other end-points included adverse events, patient tolerance and physician satisfaction.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
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
研究组 & 干预措施
Narcotrend
After 0.1µg/kg sufentanil is applied, miidazolam is given by non-anaesthetist physicians to achieve moderate levels of sedation as assessed by the Narcotrend index stage C.
干预措施: Narotrend (Device)
Narcotrend
After 0.1µg/kg sufentanil is applied, miidazolam is given by non-anaesthetist physicians to achieve moderate levels of sedation as assessed by the Narcotrend index stage C.
干预措施: Sufentanil (Drug)
Narcotrend
After 0.1µg/kg sufentanil is applied, miidazolam is given by non-anaesthetist physicians to achieve moderate levels of sedation as assessed by the Narcotrend index stage C.
干预措施: Lidocaine (Drug)
Narcotrend
After 0.1µg/kg sufentanil is applied, miidazolam is given by non-anaesthetist physicians to achieve moderate levels of sedation as assessed by the Narcotrend index stage C.
干预措施: Midazolam (Drug)
BIS
After 0.1µg/kg sufentanil is applied, midazolam is given by non-anaesthetist physicians to achieve moderate levels of sedation as assessed by bispectral index (BIS; between 70 and 85).
干预措施: BIS (Device)
BIS
After 0.1µg/kg sufentanil is applied, midazolam is given by non-anaesthetist physicians to achieve moderate levels of sedation as assessed by bispectral index (BIS; between 70 and 85).
干预措施: Sufentanil (Drug)
BIS
After 0.1µg/kg sufentanil is applied, midazolam is given by non-anaesthetist physicians to achieve moderate levels of sedation as assessed by bispectral index (BIS; between 70 and 85).
干预措施: Lidocaine (Drug)
BIS
After 0.1µg/kg sufentanil is applied, midazolam is given by non-anaesthetist physicians to achieve moderate levels of sedation as assessed by bispectral index (BIS; between 70 and 85).
干预措施: Midazolam (Drug)
No monitoring
After 0.1µg/kg sufentanil is applied, midazolam iss given by non-anaesthetist physicians according to patient's tolerance .
干预措施: Sufentanil (Drug)
No monitoring
After 0.1µg/kg sufentanil is applied, midazolam iss given by non-anaesthetist physicians according to patient's tolerance .
干预措施: Lidocaine (Drug)
No monitoring
After 0.1µg/kg sufentanil is applied, midazolam iss given by non-anaesthetist physicians according to patient's tolerance .
干预措施: Midazolam (Drug)
Lidocaine
Only topical anesthesia was applied.
干预措施: Lidocaine (Drug)
结局指标
主要结局
Dosage of Midazoam
时间窗: during the procedure
dosage of midazolam
次要结局
- patient's subjective tolerance(30minutes after bronchoscopy)
- patient's global tolerance assessed by operator(30minutes after bronchoscopy)
- adverse events rate(every 3 minutes during the procedure and at 5, 15 and 30 minutes thereafter.)
研究者
ShiYue Li
Professor
Guangzhou Institute of Respiratory Disease