Patient controlled analgesiaStandard medical treatment
Patient controlled analgesia: Patient controlled propofol sedation. 5 mg propofol iv per push. Max 8 pushes/minute
Standard medical treatment: Midazolam and/or fentanyl given intravenously as needed by endoscopy nurse
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Patient satisfaction — One hour after the procedure and one week after the procedure 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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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