Patient Controlled Propofol Sedation Versus Nurse-assisted Propofol Sedation in Diagnostic Colono… (NCT07653867) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Patient Controlled Propofol Sedation Versus Nurse-assisted Propofol Sedation in Diagnostic Colonoscopies With a Focus on Patient Satisfaction
Sweden135 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 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.
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 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.
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.
1This trial is comparing two ways of giving propofol sedation during a colonoscopy — one where I control my own dose versus one where a nurse manages it — how does my doctor feel about the safety profile of patient-controlled propofol specifically, given that I would be dosing myself?
2Since this trial is in Phase 4, which usually means the drug itself has already been established as safe, does that mean the main unknowns here are about the delivery method and patient experience rather than the propofol itself, and how does that affect the risk level for me?
3The trial hasn't started recruiting yet — does my doctor know when it's expected to open, and would waiting for it delay any colonoscopy I might need now?
4The primary outcome being measured is patient satisfaction rather than a clinical health result — does my doctor think that's relevant to my specific situation, or would a standard sedation approach already meet my needs just as well?
5If I were to enroll, would my doctor or their team be involved in my care during the procedure, or would I be seen by a separate study team, and how would that affect the continuity of my treatment?
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 examination and one week after the examination