Patient Controlled Propofol Sedation Versus Standard Sedation in Advanced Therapeutic Colonoscopy… (NCT07637279) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Patient Controlled Propofol Sedation Versus Standard Sedation in Advanced Therapeutic Colonoscopy With a Focus on Patient Satisfaction
Sweden40 participantsStarted 2026-11-01
Plain-language summary
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.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 questioneeres
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Patient satisfaction
Timeframe: One hour after the procedure and one week after the procedure