Sedation for Endoscopic Procedures

• Conditions: Endoscopic Surgical Procedure

• Registration Number: NCT05038917
• Lead Sponsor: Ostergotland County Council, Sweden

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.

Study Timeline

• Study Start: 2020-03-30
• Study First Submitted: 2021-05-26
• Status Verified: 2021-09
• Study First Submitted QC: 2021-09-08
• Last Update Submitted: 2021-09-08
• Study First Posted: 2021-09-09
• Last Update Posted: 2021-09-09
• Primary Completion: 2022-06-30
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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
• dementia
• communication problems.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dimensions of recovery recorded by Quality of Recovery 15 swedish version	Day 5	Quality of recovery (QoR15 swedish version) Max 150 points Min 0, higher scores are better

Secondary Outcome Measures

Name	Time	Method
Health literacy measured by the use of FHL (swedish version)	Before procedure (Day 0)	Health literacy (FHL swedish version), Max 0 Min 5, 0 is good, 5 is bad
Aborted or increased difficulty to performed the planned procedure	From start of procedure to the end of it (Day 0)	Procedure failure, numbers of aborted procedures and numbers of difficult performance

Trial Locations

Locations (1)

University hospital of Linköping; 🇸🇪 Linköping, Östergötland, Sweden