Sedation for Endoscopic Procedures

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05038917

Acronym

SEEUPP

Enrollment

500

Registered

2021-09-09

Start date

2020-03-30

Completion date

2022-12-31

Last updated

2021-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endoscopic Surgical Procedure

Keywords

Quality of recovery, Health Literacy, Moderate sedation, Deep sedation, Anesthesia

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Dimensions of recovery recorded by Quality of Recovery 15 swedish version	Baseline (Day 0)	Quality of recovery (QoR15 swedish version) Max 150 points Min 0, higher scores are better

Secondary

Measure	Time frame	Description
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

Countries

Sweden

Contacts

Primary ContactAndreas Nilsson, PhD

andreas.nilsson@regionostergotland.se+46(0)704417975

Backup ContactSara Lyckner, PhD-stud

sara.lyckner@regionsormland.se

Outcome results