Safety of sedation with non-anesthesiologist-administered propofol during interventional endoscopy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study prospectively collects data on sedation practices, procedure details, and patient outcomes for interventional endoscopic procedures performed at a single center. It focuses on non-anaesthesiologist-administered propofol sedation (NAPS) during technically demanding or longer interventions and in patients with higher comorbidity. The study uses standardized NAPS protocols with trained staff, continuous monitoring, oxygen support, and immediate access to emergency response if needed. Findings may clarify safety and effectiveness of NAPS in a real-world, higher-risk population undergoing ERCP, interventional EUS, or interventional EGD. No intervention beyond routine care is performed, and data are collected observationally to describe current practice and outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients ≥18 years of age at time of consent
2. Ability to understand and willingness to sign and date written informed consent document
3. Patients who undergo an interventional endoscopic procedure at Innsbruck University Hospital (ERCP, interventional EUS, interventional EGD).

Exclusion Criteria:

1. Pregnancy
2. Inability to consent
3. Respiratory instability before start of intervention (SpO2 \<90 %)
4. Oxygen treatment via nasal cannula \>3 l/min before start of intervention
5. Hemodynamic instability before start of intervention (MAP \< 65 mmHg and/or vasopressor/catecholamine therapy and/or heart rate \<50/min)

Where it's running

• Medical University of Innsbruck
  Innsbruck, Tyrol, Austria Recruiting

Study contacts

• Principal investigator: Benedikt Schaefer, MD, PhD — Medical University Innsbruck
• Study coordinator: Arno Hofer, MD
• Email: arno.hofer@tirol-kliniken.at
• Phone: +4351250424019

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.