NCT07604480已完成不适用
Remimazolam-Propofol Combination Sedation for Gastrointestinal Endoscopy: A Prospective Observational Study
University of Medicine and Pharmacy "Victor Babes" Timisoara1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2024年11月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 1
研究概览
简要总结
This prospective observational study evaluated the safety and efficacy of a remimazolam-propofol combination sedation protocol in adult patients undergoing elective gastrointestinal endoscopy at a tertiary care centre in Romania. The primary outcome was procedural completion. Secondary outcomes included time to sedation onset, recovery time, discharge readiness, total sedative doses administered, and incidence of adverse events including cardiovascular and respiratory complications.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years Elective upper or lower gastrointestinal endoscopy (gastroscopy or colonoscopy) ASA physical status I-IV Written informed consent obtained prior to enrolment
排除标准
- •Age <18 years ASA physical status V Emergency endoscopic procedures Known allergy or hypersensitivity to remimazolam, propofol, fentanyl, or any component of their formulations Severe hepatic impairment Pregnancy or breastfeeding History of difficult airway or anticipated airway management difficulties Refusal of informed consent Participation in another clinical trial at the time of enrolment
研究者
Sonia-Elena Popovici
MD, PhD candidate
University of Medicine and Pharmacy "Victor Babes" Timisoara
研究点 (1)
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