Safety of Sedation During Interventional Endoscopy

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMedical University Innsbruck

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients ≥18 years of age at time of consent

Ability to understand and willingness to sign and date written informed consent document

Patients who undergo an interventional endoscopic procedure at Innsbruck University Hospital (ERCP, interventional EUS, interventional EGD).

Disqualifiers

Pregnancy

Inability to consent

Respiratory instability before start of intervention (SpO2 <90 %)

Oxygen treatment via nasal cannula >3 l/min before start of intervention

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Sedation during interventional endoscopy

    Drug

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

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

Duration of the intervention and sedation

* Procedure duration (minutes) * Sedation duration (minutes) * Length of stay in endoscopy ward after procedure (minutes)

Time frame
periprocedural
3

resource usage

* Total propofol dose (mg) * Total midazolam dose (mg) * Additional sedatives/analgesics (mg)

Time frame
periprocedural
4

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

Other outcomes

Sponsors and contacts

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