Patient Controlled Propofol Sedation Versus Standard Sedation in Advanced Therapeutic Colonoscopy 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: Patient controlled analgesia, Standard medical treatment.
- Who it may be relevant to
- Registry conditions: Colo-rectal Polyps. 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 Therapeutic Colonoscopies
Overview
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.
Interventions
- Drug Patient controlled analgesia
Patient controlled propofol sedation. 5 mg propofol iv per push. Max 8 pushes/minute - Drug Standard medical treatment
Midazolam and/or fentanyl given intravenously as needed by endoscopy nurse
Primary outcome measures
- Patient satisfaction [Time frame: One hour after the procedure and one week after the procedure]
Secondary outcome measures (3)
- Recovery time [Time frame: <4 hours post examination]
- Procedure duration [Time frame: Postprocedure]
- 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 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.
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: NCT07637279 · PCAPS2 · 2025-524859-31-00