Optimal Procedural Sequence in Same-day Bidirectional Endoscopy With Moderate Sedation and Carbon Dioxide Insufflation: A Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 121
- 主要终点
- Sedative Doses of Midazolam
研究概览
简要总结
The Same-day bidirectional endoscopy (BDE) is commonly used in clinical practice. However, the optimal sequence of performing a same-day BDE has not been well-established.The primary aims of this study are to compare the sedative doses and patient discomfort between the study groups who received a colonoscopy followed by and EGD (colonoscopy-EGD), or an EGD followed by a colonoscopy (EGD-colonoscopy) during a same-day BDE. The secondary aim is to assess colonoscopy performance, including the cecal intubation time and adenoma detection rate between the two endoscopic sequences.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients, aged 20 to 75 years, who are scheduled for same-day bidirectional endoscopy examination for any indication are invited to participate in the study.
排除标准
- •previous gastrectomy or colectomy
- •inadequate bowel preparation,
- •obstructive lesions of the colon
- •severe colitis, gastrointestinal bleeding
- •allergy to fentanyl or midazolam
- •American Society of Anesthesiology (ASA) classification of physical status grade 3 or higher,
- •mental retardation
- •regular use of narcotics
- •refusal to provide a written informed consent.
研究组 & 干预措施
EGD-colonoscopy group
In this group, patients receiving an EGD followed by a colonoscopy during a same-day bidirectional endoscopy. Patients receive moderate conscious sedation with fentanyl and midazolam for the procedures. Gastric polypectomy will be provided when gastric polyps are found during an EGD study. Colon polypectomy will be provided when colon polyps are found during a colonoscopy study. Patients' heart rate, respiratory rate, blood pressure, and oxygen saturation will be recorded every 60 seconds during the endoscopic examinations. Patients' tolerability to EGD and colonoscopy examinations will be scaled by patients and endoscopists after the completion of the examinations. Aldrete scores are recorded15 minutes and 25 minutes after entering the recovery room. The recovery time will also be recorded.
干预措施: EGD and colonoscopy (Procedure)
Colonoscopy-EGD group
In this study group, patients receive a colonoscopy followed by an EGD during a same-day bidirectional endoscopy. Patients receive moderate conscious sedation with fentanyl and midazolam for the procedures. Colon polypectomy will be provided when colon polyps are found during a colonoscopy study. Gastric polypectomy will be provided when gastric polyps are found during an EGD study. Patients' heart rate, respiratory rate, blood pressure, and oxygen saturation will be recorded every 60 seconds during the endoscopic examinations. Patients' tolerability to colonoscopy and EGD examinations will be scaled by patients and endoscopists after the completion of the examinations. Aldrete scores are recorded15 minutes and 25 minutes after entering the recovery room. The recovery time will also be recorded.
干预措施: EGD and colonoscopy (Procedure)
结局指标
主要结局
Sedative Doses of Midazolam
时间窗: On the day of bidirectional endoscopy procedures
During bidirectional endoscopy, the total doses of midazolam were recorded and compared between the two study groups.
Sedative Doses of Fentanyl
时间窗: On the day of endoscopic procedures.
During bidirectional endoscopy, the total doses of fentanyl were recorded and compared between the two study groups.
次要结局
- Overall Duration of BDE Examinations(On the day of bidirectional endoscopy)
研究者
Chi-Liang Cheng
M.D.
Evergreen General Hospital, Taiwan