A Cross-Sectional Study on Euphoria Induced by Remimazolam During Gastrointestinal Endoscopy and Its Related Factors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 305
- 试验地点
- 1
- 主要终点
- Incidence of Euphoria Induced by Remimazolam
研究概览
简要总结
This study aims to investigate the incidence of euphoria induced by remimazolam during gastrointestinal endoscopy and explore its related factors. Gastrointestinal endoscopy, a minimally invasive procedure, often causes discomfort and anxiety for patients. Remimazolam, a short-acting benzodiazepine, is increasingly used for sedation during these procedures due to its rapid onset, short metabolism, and controlled cardiorespiratory effects. This cross-sectional study will evaluate the effect of remimazolam on patient comfort, cooperation, and satisfaction during endoscopy, aiming to optimize sedation protocols and improve clinical outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 65 years, regardless of gender.
- •Patients scheduled for routine painless gastrointestinal endoscopy, including gastroscopy, colonoscopy, or both.
- •ASA physical status classification: I or II.
- •BMI between 18 kg/m² and 28 kg/m².
- •Anticipated procedural duration of no more than 30 minutes.
- •Patients who have provided written informed consent after understanding the study purpose, procedures, and potential risks.
排除标准
- •History of psychiatric disorders such as schizophrenia, bipolar disorder, or personality disorders, or a history of alcohol, stimulant, or other substance abuse.
- •Known allergies or intolerance to any medication used in the study, including remimazolam, sufentanil, or benzodiazepines.
- •Patients requiring complex endoscopic procedures (e.g., ERCP, endoscopic submucosal dissection, endoscopic mucosal resection, or peroral endoscopic myotomy).
- •History of severe hepatic or renal disease.
- •Pregnant or lactating women.
- •Participation in another clinical study within the past three months.
- •Any condition or factor that, in the investigator's judgment, makes the patient unsuitable for participation in the study.
研究组 & 干预措施
Remimazolam Sedation Group
his cohort includes patients undergoing painless gastrointestinal endoscopy (gastroscopy, colonoscopy, or both) who receive sedation with remimazolam. The study aims to evaluate the incidence of euphoria induced by remimazolam and explore related factors. All patients receive sedation according to standard clinical guidelines, including pre-procedural sufentanil and lidocaine gel for oral preparation, followed by remimazolam for induction and maintenance.
Data collected include demographic characteristics, pre- and post-procedure euphoria scores assessed using the ARCI-MBG scale, perioperative safety indicators, and patient satisfaction.
干预措施: Remimazolam for Gastrointestinal Endoscopy Sedation (Drug)
结局指标
主要结局
Incidence of Euphoria Induced by Remimazolam
时间窗: From pre-procedure baseline to 2 hours post-procedure (Euphoria is assessed at two time points: immediately before sedation and two hours after the procedure, upon full recovery.)
he occurrence of euphoria in patients undergoing sedation with remimazolam during gastrointestinal endoscopy procedures (gastroscopy, colonoscopy, or both). Euphoria is assessed using the ARCI-MBG scale. A positive result is defined as an increase in the ARCI-MBG score post-procedure compared to pre-procedure.
次要结局
- factors Associated with Euphoria Induced by Remimazolam(From pre-procedure baseline to 2 hours post-procedure (Factors are collected before the procedure, during sedation, and 2 hours post-procedure, upon full recovery.))
研究者
Zhangjie Yu
Attending Physician
RenJi Hospital