Efficacy and Safety Study of Oliceridine Fumarate Versus Remifentanil for Analgesic Therapy in Mechanically Ventilated Subjects in the ICU
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 292
- 主要终点
- Assessment of analgesic effectiveness
研究概览
简要总结
The objective of this clinical trial is to investigate the efficacy and safety of oliceridine fumarate for analgesic treatment in mechanically ventilated subjects in the ICU. This study was conducted to answer the following questions (1) the efficacy of oliceridine fumarate for analgesic treatment in subjects with ICU mechanical ventilation (2) the safety of oliceridine fumarate for analgesic treatment in subjects with ICU mechanical ventilation. This study proposes to conduct a randomized controlled clinical trial in mechanically ventilated patients in the intensive care unit to compare the analgesic efficacy and incidence of adverse effects of two drugs, oliceridine fumarate injection and remifentanil. Subjects had an analgesic goal of CPOT <3 points and a sedation goal of RASS -2 to 0 points. Infusion syringes of remifentanil or oliceridine fumarate were prepared by a nurse according to the weight of the subjects. Subjects were enrolled in the group and were scored for analgesia and sedation related scores. Both groups received routine ICU monitoring and appropriate treatment, which was determined by the clinician.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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 aged ≥18 years and ≤80 years;
- •Admitted to the ICU and undergoing invasive mechanical ventilation with an expected duration of mechanical ventilation of more than 24 hours;
- •Subjects requiring sedation and analgesia;
- •Subjects or their guardians voluntarily participate in the study and sign an informed consent form;
排除标准
- •Pregnant or breastfeeding women;
- •Hypersensitivity to opioids (fentanyl, remifentanil, sufentanil, morphine, etc.);
- •Subjects with bronchial asthma attacks;
- •Subjects with acute intestinal obstruction;
- •Subjects who are unable to undergo RASS and CPOT assessments for various reasons, such as those with a history of psychiatric systemic disorders (schizophrenia, mania, psychosis, history of cognitive dysfunction), grand mal status epilepticus, and craniocerebral injury;
- •Severe hemodynamic instability (subjects who require administration of more than an equivalent dose of 0.5 μg/kg/min norepinephrine to maintain a MAP ≥ 65 mmHg and who, in the opinion of the investigator, are not suitable for enrollment);
- •Use of monooxygenase inhibitors (MAOIs) (see protocol appendix);
- •Chronic pain requiring long-term analgesic medication (duration of illness greater than 3 months);
- •Severe hepatic insufficiency (liver function in Child classification C);
- •Severe renal dysfunction (definition of renal dysfunction: chronic renal insufficiency [glomerular filtration rate (GFR) ≦29ml/(min1.73m3]; or long-term maintenance hemodialysis or peritoneal dialysis subjects);
- •Undergoing any clinical trial within 1 month prior to enrollment and receiving the test product;
- •ECG QT interval at screening: >450 ms for men and >470 ms for women;
- •Subjects with a desired sedation target RASS score within the range of -5 to -3 (including threshold) points;
- •Other conditions deemed unsuitable for enrollment by the investigator.
研究组 & 干预措施
Intervention group：Oliceridine Fumarate
干预措施: Oliceridine Fumarate (Drug)
Control group: Remifentanil
干预措施: Remifentanil (Drug)
结局指标
主要结局
Assessment of analgesic effectiveness
时间窗: Not more than 3 days
Percentage of time to achieve analgesic goal as a percentage of total time on medication during the study drug efficacy period (analgesic goal was CPOT \<3 points, and the start of recording was the time of initiation of medication).
次要结局
未报告次要终点
研究者
Chun Pan
professor
Sichuan Provincial People's Hospital