drugset / Trial / NCT07637279
Patient Controlled Propofol Sedation Versus Standard Sedation in Advanced Therapeutic Colonoscopy With a Focus on Patient Satisfaction
Phase 4
Not yet recruiting
40 enrolled
Karolinska Institutet
Capio Sankt Görans Hospital · collabDanderyd Hospital · collab
RandomizedParallel-groupOpen-labelHealth-services research
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.
Timeline
- Start
- 2026-11-01
- Primary completion
- 2028-06-15
- Completion
- 2028-11-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Fentanyl | Other / unclassified | 0.25 mg | Intravenous |
| Comparator | Fentanyl | Other / unclassified | 0.5 mg | Intravenous |
| Comparator | Midazolam | Small molecule | 1 mg | Intravenous |
| Comparator | Midazolam | Small molecule | 2 mg | Intravenous |
| Subject | Propofol | Small molecule | 5 mg | Intravenous |