An observational study in Sedation Complication and Sedation During GI Endoscopy, sponsored by Medical University Innsbruck. Recruiting at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Medical University Innsbruck · Observational
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.
Medical University Innsbruck is the lead sponsor of 186 studies on the registry; 48 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Consecutive adult patients undergoing therapeutic or advanced interventional endoscopic procedures (interventional endoscopic procedures including endoscopic retrograde cholangiopancreatography (ERCP), interventional endoscopic ultrasound (EUS-guided procedures), and interventional upper gastrointestinal endoscopy (including PEG placement, endoscopic treatment of stenosis, endoscopic mucosal resection [EMR], endoscopic variceal band ligation [EVBL], radiofrequency ablation [RFA], foreign body removal, and other advanced endoscopic interventions). with procedural sedation as part of routine clinical care at a tertiary referral center.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
No study-specific intervention is performed and that patients receive standard-of-care sedation.
Any sedation-related adverse event (SRAE) requiring clinical intervention and/or leading to procedure termination
* Hypoxia (SpO₂ \< 90%) * Treatment/escalation for hypoxia (increase O₂ flow, jaw thrust, bag-valve-mask ventilation, nasal high-flow therapy, intubation) * Hypotension (MAP \< 65 mmHg) * Blood pressure support (fluid administration, vasopressors/catecholamines) * Bradycardia (heart rate \< 50/min) * Treatment of bradycardia (pharmacological) * Sedation-related termination of the procedure * Resuscitation and/or death
Time frame: periprocedural
Component and severity breakdown of the primary endpoint
• Incidence of each individual SRAE component (hypoxemia, hypotension, bradycardia, intubation, procedure termination, resuscitation/death)
Time frame: periprocedural
Duration of the intervention and sedation
* Procedure duration (minutes) * Sedation duration (minutes) * Length of stay in endoscopy ward after procedure (minutes)
Time frame: periprocedural
resource usage
* Total propofol dose (mg) * Total midazolam dose (mg) * Additional sedatives/analgesics (mg)
Time frame: periprocedural
requirement of oxygen therapy
* Oxygen flow via nasal cannula at the start of intervention * High-flow nasal therapy parameters at the start of intervention
Time frame: periprocedural
Incidence of additional interventions/procedures/monitoring
* Incidence of Repeat endoscopy * Incidence of requirement for Surgery * Incidence of requirement for Interventional radiology * Incidence of ICU admission
Time frame: up to 30 days after the endoscopic intervention
Patient-reported outcome
Sedation satisfaction questionnaire (prior to discharge)
Time frame: up to 30 days after the endoscopic intervention
Procedure-related (intervention-related) adverse events
* Incidence of intraprocedural bleeding requiring intervention * Incidence of postprocedural bleeding requiring intervention * Incidence of perforation * Incidence of post-ERCP pancreatitis * Incidence of post-ERCP cholangitis
Time frame: periprocedural and 30 days after the endoscopic intervention
Effectiveness outcomes
Rate of Technical success (depending on indication)
Time frame: periprocedural
30 day outcome
* 30-day mortality * 30-day readmission
Time frame: up to 30 days after the endoscopic intervention
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — All IPD collected throughout the trial.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Beginning 3 months after the publication of results.
Access criteria: De-identified individual participant data will be made available upon reasonable request to the principal investigator compliance with applicable data protection regulations.
Started Aug 2026 (actual). Primary completion is estimated for Aug 2031, 60 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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