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ClinicalTrials.gov ID

NCT07653867

Lead Sponsor

Karolinska InstitutetOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 4

Enrollment

135Estimated

Last Update Posted

Jun 17, 2026Actual

Start Date

Nov 1, 2026Estimated

Primary Completion Date

Jun 15, 2028Estimated

Completion Date

Nov 1, 2028Estimated

Official Title

Patient-Controlled Anesthesia for Endoscopic Procedural Sedation (PCAPS). A Randomized Controlled Trial Evaluating Patient-controlled Propofol Sedation in Diagnostic Colonoscopies

Brief 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.

• Colonoscopy (Procedure)

• Self administred propofol
• Nurse assisted propofol sedation

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Primary Purpose

Health Services Research

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Karolinska InstitutetOTHER

ylva.falken@regionstockholm.se+46 123 550 00