Patient Controlled Propofol Sedation Versus Nurse-assisted Propofol Sedation in Diagnostic Colonoscopies With a Focus on Patient Satisfaction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Self administred propofol, Nurse assisted propofol sedation.
- Who it may be relevant to
- Registry conditions: Colonoscopy (Procedure). Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Patient-Controlled Anesthesia for Endoscopic Procedural Sedation (PCAPS). A Randomized Controlled Trial Evaluating Patient-controlled Propofol Sedation in Diagnostic Colonoscopies
Overview
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.
Interventions
- Drug Self administred propofol
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. - Drug Nurse assisted propofol sedation
The endoscopy nurse will administer bolus dosus of propofol (10 mg iv) as needed during the examination
Primary outcome measures
- Patient satisfaction [Time frame: One hour after the examination and one week after the examination]
Secondary outcome measures (4)
- Total propofol dose (mg) [Time frame: 0 hours after examination]
- Recovery time [Time frame: 4 hours after the examination]
- Procedure duration [Time frame: 0 hours after examination]
- Adverse events [Time frame: 30 days]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
Sweden · 2 centers
- Endoscopy Unit, StGörans Hospital — Stockholm
- Endoskopicentrum, Danderyds Hospital — Stockholm
Identifiers
NCT: NCT07653867 · PCAPS1 · 2025-524859-31-00