Ciprofol Versus Propofol for Tracheal Intubation in ICU Patients: a Randomized Controlled Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- cardiovascular collapse within 30minutes from the start of the intubation procedure
研究概览
简要总结
The physiological reserves of critically ill patients are relatively low, and the risk of complications related to tracheal intubation in the ICU is higher than in the operating room. ICU tracheal intubation complications account for approximately 40% -45% of patients, including severe hypotension (10% -43%), severe hypoxemia (9% -25%), and cardiac arrest (2% -3%).Ciprofol is a novel 2,6-disubstituted phenol derivative that targeting γ-aminobutyric acid type A (GABAA)-receptor. There are four indications of ciprofol that have been approved by NMPA in recent two years: sedation and anesthesia in non-tracheal intubation procedure/operation, induction and maintenance of general anesthesia, sedation during intensive care, sedation and maintenance in gynecological outpatient surgery. The aim of this study is to compare the effects of propofol and propofol on the circulatory system during tracheal intubation in ICU patients, in order to provide a safer induction sedation regimen for emergency tracheal intubation in critically ill patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who need to undergo tracheal intubation under sedation after entering the ICU;
- •Age range from 18 to 85 years old;
- •Patients or their families have a full understanding of the purpose and significance of this trial, voluntarily participate in this clinical trial, and sign an informed consent form.
排除标准
- •Patients who are allergic to the study drugs, or patients with contraindications to the study drugs;
- •Patients with difficult airways (MACOCHA ≥ 3 points);
- •Patients who require emergency intubation due to sudden cardiac arrest;
- •Patients who require conscious intubation;
- •Patients who can maintain mean arterial pressure (MAP) above 65mmHg using of one or more vasoactive drugs (equivalent (-)-noradrenaline > 0.3 μg kg min);
- •In a state of imminent death;
- •Pregnant and/or lactating women; Subject judged by the investigator to have any other factors unsuitable for participation in the study
研究组 & 干预措施
Ciprofol Group
干预措施: Ciprofol (Drug)
Propofol Group
干预措施: Propofol (Drug)
结局指标
主要结局
cardiovascular collapse within 30minutes from the start of the intubation procedure
时间窗: 30 minutes from the the intubation procedure
defined as occurrence of at least one of the following events: systolic blood pressure\<65 mm Hg recorded at least once; systolic blood pressure\<90 mm Hg for\>30 minutes; SBP decreased more than 20% from baseline;new requirement for, or increase of vasopressors.
次要结局
- Time from initiation of study drug administration to successful tracheal intubation (within 30 minutes)(Time from initiation of study drug administration to successful tracheal intubation (within 30 minutes))
- Success rate of sedation(30 minutes from the the intubation procedure)
- The incidence of hypoxemia within 30 minutes after tracheal intubation(30 minutes from the the intubation procedure)
- The incidence of bradycardia within 30 minutes after tracheal intubation(30 minutes from the the intubation procedure)
- Length of ICU stay and treatment outcome(From the start of randomization until patients were transferred out of the ICU or discharged)
- 28-day mortality rate(within 28 days)
- Successful intubation on the first attempt(30 minutes from the the intubation procedure)
- The incidence of cardiac arrest within 30 minutes after tracheal intubation(30 minutes from the the intubation procedure)
- new requirement or increase of vasopressors(30 minutes from the the intubation procedure)
- 28 days without mechanical ventilation(From the beginning of patients enrolled to 28 days after enrollment)
- new requirement or increase of antiarrhythmic drugs(30 minutes from the the intubation procedure)