A Phase 4 interventional study of Self administred propofol and Nurse assisted propofol sedation in Colonoscopy (Procedure), sponsored by Karolinska Institutet. Not yet recruiting at 2 sites in Sweden. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-06-17.
Sponsored by Karolinska Institutet · Phase 4, Interventional, and Health services research
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.
Participants will:
Karolinska Institutet is the lead sponsor of 1,113 studies on the registry; 267 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will self administer propofol by pushing a button (5 mg iv, 8 activations per minute resulting in max dose of 40 mg propofol/minute) as needed
Drug: Self administred propofol
The endoscopy nurse will administer propofol in bolus doses of 10 mg iv as needed
Drug: Nurse assisted propofol sedation
Patients will self administer propofol by pushing a button. When pushed a dose of 5 mg propofol will be given intravenously. The button can be pushed a maximum of 8 times per minute.
The endoscopy nurse will administer bolus dosus of propofol (10 mg iv) as needed during the examination
Patient satisfaction
Patient satisfaction measured using Patient satisfaction with sedation index (PSSI), a validated Likert-scale questionnaire with 13 questions. Each question with 5 ranks (1-5). Minimum score 13 , maximum score 65. Higher score indicates higher satisfaction with the sedation.
Time frame: One hour after the examination and one week after the examination
Total propofol dose (mg)
Total given dose during the examination
Time frame: 0 hours after examination
Recovery time
Time to patient is ready for discharge. Patient will be assesed every 15 minutes until ready for discharge, maximum 4 hours
Time frame: 4 hours after the examination
Procedure duration
Time to completion of the procedure (min)
Time frame: 0 hours after examination
Adverse events
Any adverse events related to sedation within 30 days
Time frame: 30 days
Plan to share: Yes — De-identified individual participant data (IPD) underlying the results reported in this study will be made available upon reasonable request. The shared data will include all variables necessary to reproduce the findings presented in the article. Data will be available beginning immediately following publication and will remain available for 5 years to researchers who provide a methodologically sound proposal.
Supporting information: Study protocol, Csr, Analytic code
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Karolinska Institutet