The Application of Balanced Propofol Sedation in Fiberoptic Bronchoscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 424
- 试验地点
- 1
- 主要终点
- Patient satisfaction
研究概览
简要总结
The purpose of this study is to investigate the feasibility of using balanced propofol sedation for bronchoscopy. And screen out the optimal balanced propofol sedation compatibility plan.
详细描述
Balanced propofol sedation (BPS) is a technique proposed and developed by gastroenterologists. In recent years, multiple studies have confirmed that the use of BPS in gastrointestinal endoscopy can not only ensure patient comfort, but also reduce the incidence of respiratory and circulatory suppression. Moreover, the postoperative recovery time is short. Even for non-anesthesiologists applying BPS in gastrointestinal endoscopy , it has high safety.
Compared with gastrointestinal endoscopy, bronchoscopy occupies the respiratory tract and most patients have respiratory system diseases. Therefore, it is more necessary for strict respiratory management and control of patient sedation depth. Traditional midazolam combined with opioid drugs or propofol monosedation cannot effectively meet clinical needs. The excellent sedative and analgesic effects of BPS, as well as its maintenance of respiratory and circulatory functions, make it theoretically very suitable for application in bronchoscopy. However, there is currently a lack of evidence to support the application of BPS in bronchoscopy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists classes I-IV ;
- •Patients undergo painless bronchoscopy, including bronchoscopic biopsy (bronchoscopic lesion biopsy, bronchial mucosal biopsy, bronchoscopic transmural lung biopsy, bronchoscopic needle aspiration biopsy) ,bronchoalveolar lavage and bronchoscopic treatment;
- •Normal communication skills and able to cooperate in completing this study;
- •Patients who voluntarily accept this experimental study and sign the "Trial Informed Consent Form".
排除标准
- •Patients with contraindications or allergies to anesthesia;
- •Individuals with a history of alcoholism or drug abuse;
- •Patients with contraindications for puncture of the cricoid membrane;
- •Patients with mental or neurological disorders, taking anti anxiety/depression drugs, or primary diseases with laboratory evidence indicating possible changes in hormone levels;
- •Patients with difficulty in language communication, poor understanding ability, and inability to cooperate in completing experimental studies;
- •Patients who require laryngeal mask or tracheal intubation for assisted ventilation during the examination process;
- •Patients undergoing rigid bronchoscopy treatment;
- •Patients who refuse to receive sedation or have not signed the "Trial Informed Consent Form".
研究组 & 干预措施
S-M group
Midazolam combines with sufentanil to titrate to moderate sedation for bronchoscopy.
干预措施: Midazolam and sufentanil (Drug)
S-M-P group
Midazolam and sufentanil combine with low-dose propofol to titrate to deep sedation for bronchoscopy.
干预措施: Midazolam, sufentanil and propofol (Drug)
S-R group
Remazolam combines with sufentanil to titrate to moderate sedation for bronchoscopy.
干预措施: Remazolam and sufentanil. (Drug)
S-R-P group
Remazolam and sufentanil combine with low-dose propofol to titrate to deep sedation for bronchoscopy.
干预措施: Remazolam, sufentanil and propofol (Drug)
结局指标
主要结局
Patient satisfaction
时间窗: During bronchoscopy.
The investigator needs to use VAS scores to evaluate satisfaction about sedation feeling when they accepted bronchoscopy. The score from 0 (extremely dissatisfied) to 10 (extremely satisfied).
Patient's recovery time
时间窗: The end of bronchoscopy (up to 2 hours).
The investigator needs to record the wake-up time of patients after the end of bronchoscopy.
Patient's departure time
时间窗: The end of bronchoscopy (up to 2 hours).
The investigator needs to record the patient's departure time after the end of bronchoscopy.
Clinical satisfaction
时间窗: During bronchoscopy.
The investigator needs to use VAS scores to evaluate satisfaction about doctors and nurses when they carry out the operation. The score from 0 (extremely dissatisfied) to 10 (extremely satisfied).
次要结局
- Drug dosage(Before bronchoscopy and during bronchoscopy.)
- Additional frequency of 2% lidocaine during bronchoscopy(During bronchoscopy.)
- Additional dosage of 2% lidocaine during bronchoscopy(During bronchoscopy.)
- Additional frequency of propofol during bronchoscopy(During bronchoscopy.)
- Induction time(Before bronchoscopy.)
- Additional dosage of propofol during bronchoscopy(During bronchoscopy.)
- Patient response score during bronchoscopy(During bronchoscopy.)
- Adverse reactions during bronchoscopy(During bronchoscopy)
- Adverse reactions after fully awake(The end of bronchoscopy (up to 2 hours).)
- Patient's anxiety/depression state(Day before bronchoscopy. 1, 3, 7, and 14 days after bronchoscopy.)
研究者
jixiangyu
Principal Investigator
The Affiliated Hospital of Qingdao University