NCT06731088Enrolling By Invitation4 期
Effect of Remazolam Besylate Combined With Remifentanil Analgesic Sedation on the Prognosis of Patients With Sepsis
First Affiliated Hospital of Ningbo University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年1月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The number of days without delirium or coma during the 14-day intervention period.
研究概览
简要总结
In this study, midazolam was used as a control to investigate the effect of remazolam besylate combined with remifentanil on analgesia and sedation in patients with mechanical ventilation of sepsis on the prognosis of patients, and to provide evidence for the safe application of remazolam besylate in patients with sepsis.
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
- •Mechanical ventilation patients with sepsis who are expected to stay in ICU for ≥48h;
- •The condition was allowed to remain in shallow sedation (RASS-2 ~0);
- •Obtain informed consent from patients or family members
排除标准
- •pregnancy or breastfeeding;
- •General anesthesia surgery within 48 hours;
- •Severe, pre-existing parenchymatous liver disease with clinically significant portal hypertension, Child-Pugh grade C cirrhosis or acute liver failure;
- •Patients with acute and chronic renal insufficiency requiring dialysis treatment;
- •Severe craniocerebral injury, brain tumor, increased intracranial pressure, cerebrovascular accident, coma, epileptic status, etc. 6 Medical Ethics Committee of the First Affiliated Hospital of Ningbo University;
- •Patients with a history of alcohol or drug abuse;
- •Any condition that prevents the correct assessment of cognitive function, such as speech and sensory disorders or mental disorders (language difficulties or organic mental dysfunction);
- •Failure to obtain informed consent or authorization;
- •Participate in other exploratory clinical trials within 6 months prior to screening;
- •Known or suspected allergy to the study drug.
研究组 & 干预措施
Midazolam
Active Comparator
干预措施: Midazolam (Drug)
Remazolam benzenesulfonate
Active Comparator
干预措施: Remazolam besylate (Drug)
结局指标
主要结局
The number of days without delirium or coma during the 14-day intervention period.
时间窗: From enrollment to the end of treatment at 14 days
次要结局
未报告次要终点
研究者
研究点 (1)
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