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Safety of Sedation During Interventional Endoscopy

Study acronym: SCOPE-SAFE
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
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.
Trial Details
NCT Number NCT07872657
Lead Sponsor Medical University Innsbruck
Conditions
(from sponsor)
Sedation Complication, Sedation During GI Endoscopy
Enrollment 500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov