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NOT YET RECRUITING
NCT07637279
PHASE4

Patient Controlled Propofol Sedation Versus Standard Sedation in Advanced Therapeutic Colonoscopy With a Focus on Patient Satisfaction

Sponsor: Karolinska Institutet

View on ClinicalTrials.gov

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.

Official title: Patient-Controlled Anesthesia for Endoscopic Procedural Sedation (PCAPS). A Randomized Controlled Trial Evaluating Patient-controlled Propofol Sedation in Therapeutic Colonoscopies

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-11-01

Completion Date

2028-11-01

Last Updated

2026-06-09

Healthy Volunteers

No

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

Locations (2)

Endoscopy Unit, StGörans Hospital

Stockholm, Sweden

Endoskopicentrum, Danderyds Hospital

Stockholm, Sweden