NCT07637279尚未招募4 期
Patient-Controlled Anesthesia for Endoscopic Procedural Sedation (PCAPS). A Randomized Controlled Trial Evaluating Patient-controlled Propofol Sedation in Therapeutic Colonoscopies
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 2
研究概览
简要总结
The goal of this clinical trial is to learn if patient administered propofol sedation results in superior patient satisfaction compared to standard conscious sedation in advanced therapeutic endoscopy.
• Does self administration of the sedative propofol increase patient satisfaction? Researchers will compare patient administered propofol sedation (where the patient administers propofol by pushing a button) with standard conscious sedation
Participants will:
- Be randomized to either sedation route.
- Answer a preendoscopy questioneere and a postendoscopy questioneere 1 hour after the examination as well as one week after the examination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •Scheduled for elective diagnostic colonoscopy in propofol sedation
- •Able to understand the study information and provide inform consent
- •Able to understand and use the patient-controlled sedation device
- •Able to complete study questioneeres
排除标准
- •ASA >=III
- •Known hypersensitivity or contraindication to propofol or any excipient in the formulation.
- •Pregnancy or breastfeeding.
- •Inability to provide valid informed consent
- •Cognitive impairment, severe psychiatric illness, or other condition limiting reliable participation or questionnaire completion.
- •Inability to understand study procedures or insufficient language proficiency without available validated study support.
- •History of serious adverse reaction or complication related to sedation or anesthesia.
研究者
Richard Marsk
Associate professor
Karolinska Institutet
研究点 (2)
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