Patient Controlled Propofol Sedation Versus Nurse-assisted Propofol Sedation in Diagnostic Colonoscopies With a Focus on Patient Satisfaction
Starting soon · Phase 4
Conditions studied: Colonoscopy (Procedure)
In brief
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.
Key facts
- Study ID
- NCT07653867
- Run by
- Karolinska Institutet
- People needed
- 135
- Starts
- 2026-11-01
- Expected to finish
- 2028-11-01
- Last updated by the study team
- 2026-06-17
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Endoscopy Unit, StGörans Hospital — Stockholm, Sweden
- Endoskopicentrum, Danderyds Hospital — Stockholm, Sweden
Full record on ClinicalTrials.gov
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