Sedation for Endoscopic Procedures - a Follow-up Study of Efficiency and Safety
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Endoscopic Surgical Procedure
- Sponsor
- Ostergotland County Council, Sweden
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Dimensions of recovery recorded by Quality of Recovery 15 swedish version
- Last Updated
- 4 years ago
Overview
Brief Summary
Endoscopic procedures for biliary strictures, stenting or drainage (ERCP) and ultrasonic imaging or biopsies (EUS) are performed under sedation or anesthesia. The main purpose of the study is to evaluate aspects of procedure treatability and patients´ quality of recovery.
Detailed Description
The main aim of this study is to evaluate the effects on treatability and procedure failur; also aspects of post-procedure quality of recovery from patients cognitive function and from the choice of sedation/anesthesia for ERCP and EUS-procedures. Before endoscopic procedures, patients do not always read the written information sent to them. That´s a problem since patients tend to be insufficient prepared for the procedures. Therefore, evaluation of patients' health literacy was performed. Patients are sedated (patient-controlled sedation or by nurse anesthetists) or in general anesthesia. No randomisation.
Investigators
Andreas Nilsson
Senior nurse anesthetist, Researcher, Principal Investigator
Ostergotland County Council, Sweden
Eligibility Criteria
Inclusion Criteria
- •Adult patients (≥18 years)
- •Patients cheduled for ERCP or/and EUS
- •Patients who have given their informed and written concent to participate
Exclusion Criteria
- •Patients with
- •confusion
- •communication problems.
Outcomes
Primary Outcomes
Dimensions of recovery recorded by Quality of Recovery 15 swedish version
Time Frame: Day 5
Quality of recovery (QoR15 swedish version) Max 150 points Min 0, higher scores are better
Secondary Outcomes
- Health literacy measured by the use of FHL (swedish version)(Before procedure (Day 0))
- Aborted or increased difficulty to performed the planned procedure(From start of procedure to the end of it (Day 0))