Remimazolam for Colonoscopy in IBD Patients
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Patient satisfaction
研究概览
简要总结
The goal of this clinical trial is to compare two sedation regimens-remimazolam and midazolam-for colonoscopy in adult patients with inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis.
The main questions it aims to answer are:
- Does remimazolam provide patient satisfaction that is non-inferior to midazolam during colonoscopy?
- Does remimazolam allow faster recovery and discharge readiness compared to midazolam?
Researchers will compare sedation with remimazolam plus fentanyl to sedation with midazolam plus fentanyl to see if remimazolam improves patient experience and procedural efficiency.
Participants will:
- Receive either remimazolam or midazolam, each combined with fentanyl, during their scheduled colonoscopy
- Complete a short questionnaire to rate their satisfaction after the procedure
- Be assessed for recovery using a standardized discharge score at 10 and 20 minutes after the procedure
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
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm 2 (Remimazolam + Fentanyl)
ARM 2: Participants receive intravenous remimazolam plus fentanyl for procedural sedation during colonoscopy
干预措施: Intravenous remimazolam (5 mg initially, with optional 2.5 mg boluses) plus fentanyl (100 mcg) for procedural sedation. (Drug)
Arm 1 (Midazolam + Fentanyl)
Arm Description: ARM 1: Participants receive intravenous midazolam plus fentanyl for procedural sedation during colonoscopy.
干预措施: Intravenous midazolam (3 mg initially, with optional 3 mg boluses) plus fentanyl (100 mcg) for procedural sedation. (Drug)
结局指标
主要结局
Patient satisfaction
时间窗: Immediately post-procedure
Proportion of patients reporting at least "satisfied" with sedation (Likert scale 1-4, 3 or 4 points)
次要结局
- Discharge readiness 10'(10 minutes post-procedure)
- Patient high satisfaction(Immediately post-procedure)
- Maximum net benefit(10 minutes post-procedure)
- Incidence of treatment-emergent adverse events(Throughout the observation period (i.e., until discharge))
- Dischatge readiness 20'(20 minutes post-procedure)