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.
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
ASA >=III
Known hypersensitivity or contraindication to propofol or any excipient in the formulation.
Pregnancy or breastfeeding.
Inability to provide valid informed consent
Parallel
Patient controlled analgesia
DrugPatient controlled propofol sedation. 5 mg propofol iv per push. Max 8 pushes/minute
Standard medical treatment
DrugMidazolam and/or fentanyl given intravenously as needed by endoscopy nurse
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.
Recovery time
Time before the patient can be discharged from the endoscopy unit.
Procedure duration
Time to completion of the procedure (min)
Adverse events
Any adverse events related to sedation within 30 days
Click on the lead sponsor to view all of their trials.
Karolinska Institutet
Lead sponsor
Danderyd Hospital
Collaborator
Capio Sankt Görans Hospital
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
