Sedation for Endoscopic Procedures

Endoscopic Surgical Procedure Clinical Trial

— SEEUPP  

Official title:

Sedation for Endoscopic Procedures - a Follow-up Study of Efficiency and Safety

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05038917
• Other study ID #: SEEUPP 04545/02915
• Status: Recruiting
• Start date: March 30, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2021
• Source: Ostergotland County Council, Sweden
• Contact: Andreas Nilsson, PhD
• Phone: +46(0)704417975
• Email: andreas.nilsson[@]regionostergotland.se
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Endoscopic Surgical Procedure

Locations

Country	Name	City	State
Sweden	University hospital of Linköping	Linköping	Östergötland

Sponsors (1)

Lead Sponsor	Collaborator
Ostergotland County Council, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dimensions of recovery recorded by Quality of Recovery 15 swedish version	Quality of recovery (QoR15 swedish version) Max 150 points Min 0, higher scores are better	Baseline (Day 0)
Primary	Dimensions of recovery recorded by Quality of Recovery 15 swedish version	Quality of recovery (QoR15 swedish version) Max 150 points Min 0, higher scores are better	Day 1
Primary	Dimensions of recovery recorded by Quality of Recovery 15 swedish version	Quality of recovery (QoR15 swedish version) Max 150 points Min 0, higher scores are better	Day 5
Secondary	Health literacy measured by the use of FHL (swedish version)	Health literacy (FHL swedish version), Max 0 Min 5, 0 is good, 5 is bad	Before procedure (Day 0)
Secondary	Aborted or increased difficulty to performed the planned procedure	Procedure failure, numbers of aborted procedures and numbers of difficult performance	From start of procedure to the end of it (Day 0)