Clinical Study of Remazolam Besylate for Sedation During Endoscopic Hemostatic Treatment of Esophageal and Gastric Variceal Bleeding
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Sedation scores
研究概览
简要总结
Remazolam besylate was used for sedation during endoscopic hemostasis in patients with esophageal and gastric varices rupture and bleeding in liver cirrhosis. The onset time, recovery time and incidence of adverse reactions were observed.
详细描述
Esophagogastric variceal bleeding (EGVB) is one of the most serious and common complications of liver cirrhosis. Endoscopic hemostasis is the most widely used and important method for the prevention and treatment of EGVB. The treatment of varicose veins hemostasis under gastroscope has the problem of long operation time. Patients are prone to nausea, vomiting and excessive secretions due to nervousness and fear, which affect endoscopic insertion and observation, leading to failure of ligation and massive bleeding, and even death. Therefore, appropriate analgesic and sedative drugs are necessary to ensure endoscopic treatment and improve the prognosis. Remimazolam, an ultra-short-acting benzodiazepine drug, is obtained by introducing metabolizable methyl propionate side chain into midazolam. It may have a good effect on sedation during endoscopic hemostasis in cirrhotic patients with ruptured esophageal and gastric varices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 diagnosed with bleeding from ruptured esophageal and gastric varices
- •Endoscopic hemostatic treatment was performed
- •Body Mass Index(BMI)18～28kg/m2
排除标准
- •History or evidence of increased risk of sedation/anesthesia;
- •Pregnant and lactating women;
- •Have participated in other drug trials within 30 days prior to enrollment;
- •those with contraindications to propofol, opioids and their remedies;
- •Unwilling to sign informed consent.
研究组 & 干预措施
Remimazolam besylate
The experimental group was given remazolam besylate for sedation
干预措施: Remimazolam besylate (Drug)
propofol
The control group was sedated with propofol
干预措施: Propofol (Drug)
结局指标
主要结局
Sedation scores
时间窗: From the begin to 48 hours after procedure
sedation scores were performed during administration,Richmond Agitation-Sedation Scale（RASS）1\~-2 was defined as compliance,Otherwise, sedation was considered inadequate
次要结局
- Rate of adverse events(Within 2 hours from the start of administration to the end of administration)
- Vital signs(From the begin to 48 hours after procedure)