Patient Satisfaction and Safety With Propofol Based Sedation With or Without Fentanyl for Gastrointestinal Endoscopy :a Prospective ,Randomized ,and Cohort Study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 500
- 主要终点
- Satisfaction assessed by the rate of vomit and diazzy after the procedure
研究概览
简要总结
Patient satisfaction and safety with propofol based sedation with or without fentanyl for gastrointestinal endoscopy
详细描述
This study divide patients into two groups, one will be given propofol midazolam and fentanyl; another group was given propofol with midazolam without fentanyl; to observe two groups of patients blood pressure, body movement, and propofol dosage , and the difference in operator satisfaction, and how many people need to give fentanyl again; and two groups of patients after the operation of the reaction, if there are dizziness, nausea, and other adverse reactions; finally, the differences of these two schemes in different populations were analyzed, and the rationalization and individualized medication will be put forward.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged 18 or older
- •Patients scheduled for an outpatient gastrointestinal endoscopy by the principal investigator.
排除标准
- •Patients with a history of colorectal surgery
- •Patients with ASA class 4 or 5,
- •Patients with pre-existing hypoxaemia (SpO2<90%),
- •Patients with hypotension (SBP<90mmHg)
- •Patients with bradycardia (HR<50 bpm)
- •patients with severe chronic renal failure (creatinine clearance<30 ml/min)
- •patients with uncontrolled hypertension (systolic blood pressure>170 mm Hg, diastolic blood pressure>100 mm Hg)
- •patients with pregnancy or lactation
- •Patients hemodynamically unstable
- •Patients unable to give informed consent
- •Patients with a history of drug allergies;
研究组 & 干预措施
Control group
Participants are given standard regimen: 50-200mg propofol and 1 mg midazolam
干预措施: 50-200mg propofol (Drug)
Control group
Participants are given standard regimen: 50-200mg propofol and 1 mg midazolam
干预措施: 1 mg midazolam (Drug)
Fentanyl group
Participants are given intervention regimen: 50ug fentanyl, plus 50-200mg propofol and 1 mg midazolam.
干预措施: 50-200mg propofol (Drug)
Fentanyl group
Participants are given intervention regimen: 50ug fentanyl, plus 50-200mg propofol and 1 mg midazolam.
干预措施: 50ug fentanyl (Drug)
Fentanyl group
Participants are given intervention regimen: 50ug fentanyl, plus 50-200mg propofol and 1 mg midazolam.
干预措施: 1 mg midazolam (Drug)
结局指标
主要结局
Satisfaction assessed by the rate of vomit and diazzy after the procedure
时间窗: half a year
Rates of vomit and diazzy of patients after the procedure between the two groups
次要结局
- Safety assessed by the rate of hypoxia during the procedure(half a year)
- Safety assessed by the rate of hypotention during the procedure(half a year)
- Safety assessed by the rate of hyoxemia during the procedure(half a year)
- Safety assessed by the rate of breadycardia during the procedure(half a year)
- Safety assessed by the rate of required airway management during the procedure(half a year)
- Safety assessed by the rate of involuntary movement during the procedure(half a year)
研究者
Yanqing Li
Principal Investigator
Shandong University