Patient Controlled Propofol Sedation Versus Nurse-assisted Propofol Sedation in Diagnostic Colonoscopies With a Focus on Patient Satisfaction (PCAPS1)
Patient-Controlled Anesthesia for Endoscopic Procedural Sedation (PCAPS). A Randomized Controlled Trial Evaluating Patient-controlled Propofol Sedation in Diagnostic Colonoscopies
The goal of this clinical trial is to learn if patient administered propofol sedation results in superior patient satisfaction compared to nurse administered propofol sedation in diagnostic colonoscopies.
• 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 nurse administered propofol sedation (where a nurse gives the patient bolus doses of propofol as deemed necessary)
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.
研究概览
研究类型
注册 (估计的)
阶段
- 第四阶段
联系人和位置
学习联系方式
- 姓名：Richard E Marsk, Docent
- 电话号码：+46 8 123 71956
- 邮箱：richard.marsk@ki.se
学习地点
-
-
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Stockholm、瑞典
- Endoscopy Unit, StGörans Hospital
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接触：
- Tamaki Ichiya, MD, PhD student
- 电话号码：+46 8 587 010 00
- 邮箱：tamaki.ichiya@ki.se
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Stockholm、瑞典
- Endoskopicentrum, Danderyds Hospital
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接触：
- Ylva Falkén, MD,PhD
- 电话号码：+46 123 550 00
- 邮箱：ylva.falken@regionstockholm.se
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-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Scheduled for elective diagnostic colonoscopy in propofol sedation
- Able to understand the study information and provide inform consent
- ASA I-II
- Able to understand and use the patient-controlled sedation device
- Able to complete study quistioneeres
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Patient controlled propofol sedation
Patients will self administer propofol by pushing a button (5 mg iv, 8 activations per minute resulting in max dose of 40 mg propofol/minute) as needed
|
Patients will self administer propofol by pushing a button.
When pushed a dose of 5 mg propofol will be given intravenously.
The button can be pushed a maximum of 8 times per minute.
|
|
有源比较器：Nurse assisted propofol sedation
The endoscopy nurse will administer propofol in bolus doses of 10 mg iv as needed
|
The endoscopy nurse will administer bolus dosus of propofol (10 mg iv) as needed during the examination
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Patient satisfaction
大体时间：One hour after the examination and one week after the examination
|
Patient satisfaction measured using Patient satisfaction with sedation index (PSSI), a validated Likert-scale questionnaire with 13 questions.
Each question with 5 ranks (1-5).
Minimum score 13 , maximum score 65.
Higher score indicates higher satisfaction with the sedation.
|
One hour after the examination and one week after the examination
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Adverse events
大体时间：30 days
|
Any adverse events related to sedation within 30 days
|
30 days
|
|
Total propofol dose (mg)
大体时间：0 hours after examination
|
Total given dose during the examination
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0 hours after examination
|
|
Recovery time
大体时间：4 hours after the examination
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Time to patient is ready for discharge.
Patient will be assesed every 15 minutes until ready for discharge, maximum 4 hours
|
4 hours after the examination
|
|
Procedure duration
大体时间：0 hours after examination
|
Time to completion of the procedure (min)
|
0 hours after examination
|
合作者和调查者
调查人员
- 首席研究员：Richard E Marsk, Docent、Karolinska Institutet
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- PCAPS1
- 2025-524859-31-00 (克蒂斯)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
De-identified individual participant data (IPD) underlying the results reported in this study will be made available upon reasonable request. The shared data will include all variables necessary to reproduce the findings presented in the article.
Data will be available beginning immediately following publication and will remain available for 5 years to researchers who provide a methodologically sound proposal.
IPD 共享时间框架
IPD 共享支持信息类型
- 研究方案
- 分析代码
- 企业社会责任
药物和器械信息、研究文件
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研究美国 FDA 监管的设备产品
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