2025-524859-31-00招募中4 期
Patient-Controlled Anesthesia for endoscopic Procedural Sedation – PCAPS study
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 175
- 试验地点
- 2
- 主要终点
- Patient satisfaction measured using a validated questionnaire
研究概览
简要总结
The primary objective is to evaluate whether patient-controlled propofol sedation results in higher patient satisfaction compared with established sedation methods.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Scheduled for elective diagnostic colonoscopy in propofolsedation (study 1) or elective therapeutic colonoscopy (study 2)
- •Age 18 years or older
- •Able to understand the study information and provide written informed consent.
- •American Society of Anesthesiologists (ASA) physical status classification I–II.
- •Able to understand and use the patient-controlled sedation device and complete study questionnaires.
排除标准
- •ASA physical status classification III or higher.
- •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.
结局指标
主要结局
Patient satisfaction measured using a validated questionnaire
Patient satisfaction measured using a validated questionnaire
次要结局
- Total dose of propofol delivered (mg)
- Procedure time
- Recovery time
- Adverse events
- Procedure completion rate
研究者
Richard Marsk
Scientific
Karolinska Institutet
研究点 (2)
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