Ciprofol vs Propofol for Reducing Hypoxia Incidence in Intravenous Anesthesia During Elective Endoscopic Retrograde Cholangiopancreatography-A Randomized Double Blinded Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- the incidence of hypoxia
研究概览
简要总结
Intravenous anesthesia has been widely used in endoscopic retrograde cholangiopancreatography (ERCP). In the past decade, many practices have been carried out under the propofol-based monitored anesthesia care without endotracheal intubation in patients undergoing ERCP.
Ciprofol is a newly developed intravenous anesthetic with a potency 4-5 times than that of propofol. Ciprofol seems a promising anesthetic agent for intravenous anesthesia but the evidence supported its application in ERCP is still limited.
详细描述
This is a prospective, randomized, double-blind trial comparing the incidence of hypoxia in the propofol versus ciprofol intravenous Anesthesia. A total 136 patients will be recruited and randomly assigned to either the propofol or the ciprofol group. The primary outcome is the proportion of patients experiencing hypoxia. The secondary outcomes include: the incidence of hypotension in perioperative period; the incidence of conversion from intravenous anesthesia to general anesthesia; sedation-related procedure interruption; carbon dioxide( CO2) accumulation during operation; Patients' satisfaction with anesthesia and postoperative recovery / VAS score / incidence of nausea and vomiting; the incidence of intraoperative and postoperative adverse events, such as adverse excretion, severe hypoxemia, severe circulatory dysfunction; length of stay and mortality within 30 days after operation.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing ERCP, ASA I-III
- •normal renal function
- •BMI ≥ 18kg/m 2 and ≤ 30kg/m 2
排除标准
- •Previous serious cerebrovascular accidents and other neurological diseases
- •mental diseases, long-term use of drugs that affect the function of the central nervous system, benzodiazepines or opioids
- •history of anesthetic allergy
- •preoperative hypotension or preoperative SpO2 < 90%, or chronic respiratory failure
- •patients suspected of having difficult airways
- •screening for drug addiction and alcohol abuse within the first 3 months (> = 6standarddrinks/day)
- •patients diagnosed with severe cardiopulmonary disease, or respiratory or respiratory diseases such as sleep apnea syndrome;
- •bradycardia or atrioventricular block.
- •participate in other clinical trials within 4 weeks;
- •cognitive or communication abnormalities determined by the researchers;
- •emergent and critical conditions during the operation;
- •other conditions that the researchers believe are not suitable to participate in the study.
研究组 & 干预措施
Propofol group
patients in Propofol group receive sufentanil+ propofol
干预措施: Propofol (Drug)
Ciprofol group
patients in Ciprofol group receive sufentanil+ ciprofol
干预措施: Ciprofol (Drug)
结局指标
主要结局
the incidence of hypoxia
时间窗: from the induction of anesthesia to the patient leaving the postanesthesia care unit，about an average of 1.5 hours
the definition of hypoxemia: any event of SpO2 (oxygen saturation measured by pulse oximetry) \< 90%
次要结局
- patient satisfaction score(5 minutes)
- the incidence of postoperative adverse bile excretion(30 days after operation)
- the incidence of mortality within 30 days after operation(30 days after operation)
- sedation-related procedure interruption(from the induction of anesthesia to completion of ERCP, about 30 minutes)
- the incidence of severe postoperative hypoxia(30 days after operation)
- the incidence of hypotension(from the induction of anesthesia to the patient leaving the postanesthesia care unit，about an average of 1.5 hours)
- conversion from intravenous anesthesia to general anesthesia(from the induction of anesthesia to completion of ERCP, about 30 minutes)
- the incidence of severe postoperative circulatory disfunction(30 days after operation)
- the incidence of hypercapnia(5 minutes each time（base line, 10 minutes after beginning of surgery, completion of surgery, 10 minutes after awakening）)
- visual analog scale (VAS) scores(30 seconds)
- length of stay(2-7days)