Comparison of Analgesic and Sedative Effects of Esmketamine and Remifentanil Combined With Propofol Respectively in Septic Shock Patients With Invasive Mechanical Ventilation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- Norepinephrine dosage in two groups
研究概览
简要总结
Septic shock patients with invasive mechanical ventilation who were randomly enrolled in ICU were divided into esketamine group (test group) and remifentanil group (control group) according to the ratio of 1:1. The dose of vasopressor, the time of mechanical ventilation, the incidence of intestinal dysfunction and the dose of propofol were compared between the two groups. Through statistical analysis, it was determined whether esketamine combined with propofol could improve the prognosis of septic shock patients with invasive mechanical ventilation and reduce the adverse reactions of analgesic and sedative drugs compared with remifentanil combined with propofol.
详细描述
The purpose of this study is to determine whether esketamine combined with propofol can improve the prognosis and reduce the adverse effects of analgesic and sedative drugs in septic shock patients undergoing invasive mechanical ventilation compared with remifentanil combined with propofol.
Study methods: septic shock patients with invasive mechanical ventilation in ICU were randomly divided into esketamine group (test group) and remifentanil group (control group) according to the ratio of 1:1. 120 patients are expected to be enrolled. The dose of vasopressor, the time of mechanical ventilation, the incidence of intestinal dysfunction and the dose of propofol were compared between the two groups. Through statistical analysis, it was determined whether esketamine combined with propofol could improve the prognosis of septic shock patients with invasive mechanical ventilation and reduce the adverse reactions of analgesic and sedative drugs compared with remifentanil combined with propofol.
From January 1, 2023 to January 1, 2024, the clinical study of the patients (60 cases) enrolled in the first phase was completed as expected in the study protocol. Stage objective: to count the relevant detection indicators of the two groups of patients, analyze and compare whether there is a difference between the primary endpoint and the secondary observation endpoint, and write a research paper and a mid-term summary.
From January 1, 2024 to January 1, 2025, the clinical study of patients (60 cases) enrolled in the second phase was completed according to the research protocol. Stage objective: to count the relevant detection indicators of the two groups of patients, analyze and compare whether there is a difference between the primary endpoint and the secondary observation endpoint, and write a research paper and a conclusion report.
Publication form of research results: 1-2 academic papers published in domestic or international journals.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (aged 18-75 years)
- •Septic shock patients with invasive mechanical ventilation
- •Use norepinephrine (the only vasoactive drug) to maintain the target map ≥ 65 mmHg
- •BMI 18.5-23.9kg/m2
排除标准
- •Pregnant or lactating women;
- •Patients allergic to planned drugs;
- •Hypertension patients with poor control;
- •Patients with mental illness, chronic pain, seizures, elevated intracranial pressure, severe ischemic heart disease, and bronchial asthma;
- •Patients included in other trial items;
- •Other reasons that the researcher considers unsuitable to participate in this study.
研究组 & 干预措施
Analgesia and sedation with esmketamine combined with propofol
干预措施: Esketamine (Drug)
Analgesia and sedation with esmketamine combined with propofol
干预措施: propofol (Drug)
Remifentanil combined with propofol for analgesia and sedation
干预措施: Remifentanil (Drug)
Remifentanil combined with propofol for analgesia and sedation
干预措施: propofol (Drug)
结局指标
主要结局
Norepinephrine dosage in two groups
时间窗: 2 years
mg/kg
次要结局
- The incidence of intestinal dysfunction(2 years)
- Time of mechanical ventilation(During hospitalization, an average of 4 days)
研究者
Yuting Li
Principal Investigator
The First Hospital of Jilin University