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Clinical Trials in Sweden / NCT07637279
Starting soon Phase 4

Patient Controlled Propofol Sedation Versus Standard Sedation in Advanced Therapeutic Colonoscopy With a Focus on Patient Satisfaction

NCT07637279 · tracked via the Priya Life Science Sweden tracker
Phase
Phase 4
Started
2026-11-01
Last updated
2026-06-09

Condition(s) studied

Colo-rectal Polyps

Investigational drug(s) / intervention(s)

Patient controlled analgesiaStandard medical treatment

Patient controlled analgesia: Patient controlled propofol sedation. 5 mg propofol iv per push. Max 8 pushes/minute

Standard medical treatment: Midazolam and/or fentanyl given intravenously as needed by endoscopy nurse

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Endoscopy Unit, StGörans Hospital Stockholm Sweden
Endoskopicentrum, Danderyds Hospital Stockholm Sweden

More Karolinska Institutet trials in Sweden

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07637279 on ClinicalTrials.gov ↗ ← All trials in Sweden