← Back to all trials
Not Yet Recruiting
NCT07637279
Patient Controlled Propofol Sedation Versus Standard Sedation in Advanced Therapeutic Colonoscopy With a Focus on Patient Satisfaction
Conditions: Colo-rectal Polyps
Sex: All
Ages: 18 Years – 90 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 40
Sponsor: Karolinska Institutet
Location: Endoscopy Unit, StGörans Hospital Stockholm
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 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.
Source: ClinicalTrials.gov (NCT07637279). StuddyBuddy aggregates publicly available trial information.