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RECRUITING
NCT07872657

Safety of Sedation During Interventional Endoscopy

Sponsor: Medical University Innsbruck

View on ClinicalTrials.gov

Summary

Sedation is routinely used during interventional endoscopic procedures to improve patient comfort and optimize procedural conditions. Non-anaesthesiologist-administered propofol sedation (NAPS) has been demonstrated to be safe and effective for many endoscopic procedures, including complex interventions such as endoscopic retrograde cholangiopancreatography (ERCP). However, evidence supporting its use during technically demanding or prolonged procedures and in patients with severe comorbidities (ASA class ≥ III) remains limited. At our institution, interventional endoscopic procedures have been routinely performed for many years using standardized NAPS protocols, including in higher-risk patients, with comprehensive staff training, continuous patient monitoring, supplemental oxygen administration, and immediate access to an emergency response team. This non-interventional observational study will prospectively collect data on sedation practices, procedural characteristics, and sedation-related outcomes during routine interventional endoscopy without altering standard clinical care. The primary objective is to evaluate the safety of NAPS across a broad spectrum of interventional endoscopic procedures and patient risk profiles, thereby providing real-world evidence to inform future clinical practice and guideline recommendations.

Official title: Safety of Sedation During Interventional Endoscopy - A Non-interventional Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

500

Start Date

2026-08-12

Completion Date

2031-10

Last Updated

2026-10-13

Healthy Volunteers

No

Interventions

DRUG

Sedation during interventional endoscopy

No study-specific intervention is performed and that patients receive standard-of-care sedation.

Locations (1)

Medical University of Innsbruck

Innsbruck, Tyrol, Austria