Sedation ComplicationSCOPE-SAFENCT07872657
Safety of Sedation During Interventional Endoscopy
An observational study of Sedation Complication and Sedation During GI Endoscopy, run by Medical University Innsbruck at 1 site in Austria.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sedation Complication, Sedation During GI Endoscopy
- What is being tested?
- Sedation during interventional endoscopy
- How many people
- 500 participants
- Where
- 1 siteAustria
- Study dates
- 12 Aug 2026to Oct 2031
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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).
Who cannot join
- Pregnancy
- Inability to consent
- Respiratory instability before start of intervention (SpO2 <90 %)
- Oxygen treatment via nasal cannula >3 l/min before start of intervention
- Hemodynamic instability before start of intervention (MAP < 65 mmHg and/or vasopressor/catecholamine therapy and/or heart rate <50/min)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Andreas Schmiderer, MD contact
Austria1 site, 1 recruiting
- Recruiting
Medical University of Innsbruck
Innsbruck, Tyrol, 6020
Arno Hofer, MD, +4351250424019, arno.hofer@tirol-kliniken.at
About this study
Official title: Safety of Sedation During Interventional Endoscopy - A Non-interventional Study
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.
- Being tested
- Sedation during interventional endoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sedation during interventional endoscopyDrug
No study-specific intervention is performed and that patients receive standard-of-care sedation.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: periprocedural
Secondary outcomes (9)
Component and severity breakdown of the primary endpoint
- Incidence of each individual SRAE component (hypoxemia, hypotension, bradycardia, intubation, procedure termination, resuscitation/death)
Measured: periprocedural
Duration of the intervention and sedation
- Procedure duration (minutes)
- Sedation duration (minutes)
- Length of stay in endoscopy ward after procedure (minutes)
Measured: periprocedural
resource usage
- Total propofol dose (mg)
- Total midazolam dose (mg)
- Additional sedatives/analgesics (mg)
Measured: 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
Measured: 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
Measured: up to 30 days after the endoscopic intervention
Patient-reported outcome
Sedation satisfaction questionnaire (prior to discharge)
Measured: 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
Measured: periprocedural and 30 days after the endoscopic intervention
Effectiveness outcomes
Rate of Technical success (depending on indication)
Measured: periprocedural
30 day outcome
- 30-day mortality
- 30-day readmission
Measured: up to 30 days after the endoscopic intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start12 Aug 2026
- Primary completionAug 2031 (estimated)
- Study completionOct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Sedation ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benedikt Schaefer, MD, PhD, Principal investigator, Medical University Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07872657
- Sponsor's protocol ID
- 2026-0001-St
- Acronym
- SCOPE-SAFE
- Status last verified
- Jul 2026
- First submitted
- 13 Aug 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD collected throughout the trial.
Publications
Azimaraghi O, Bilal M, Amornyotin S, Arain M, Behrends M, Berzin TM, Buxbaum JL, Choice C, Fassbender P, Sawhney MS, Sundar E, Wongtangman K, Leslie K, Eikermann M. Consensus guidelines for the perioperative management of patients undergoing endoscopic retrograde cholangiopancreatography. Br J Anaesth. 2023 Jun;130(6):763-772. doi: 10.1016/j.bja.2023.03.012. Epub 2023 Apr 14.
PubMed 37062671Smith ZL, Mullady DK, Lang GD, Das KK, Hovis RM, Patel RS, Hollander TG, Elsner J, Ifune C, Kushnir VM. A randomized controlled trial evaluating general endotracheal anesthesia versus monitored anesthesia care and the incidence of sedation-related adverse events during ERCP in high-risk patients. Gastrointest Endosc. 2019 Apr;89(4):855-862. doi: 10.1016/j.gie.2018.09.001. Epub 2018 Sep 11.
PubMed 30217726Rex DK, Deenadayalu VP, Eid E, Imperiale TF, Walker JA, Sandhu K, Clarke AC, Hillman LC, Horiuchi A, Cohen LB, Heuss LT, Peter S, Beglinger C, Sinnott JA, Welton T, Rofail M, Subei I, Sleven R, Jordan P, Goff J, Gerstenberger PD, Munnings H, Tagle M, Sipe BW, Wehrmann T, Di Palma JA, Occhipinti KE, Barbi E, Riphaus A, Amann ST, Tohda G, McClellan T, Thueson C, Morse J, Meah N. Endoscopist-directed administration of propofol: a worldwide safety experience. Gastroenterology. 2009 Oct;137(4):1229-37; quiz 1518-9. doi: 10.1053/j.gastro.2009.06.042. Epub 2009 Jun 21.
PubMed 19549528Wehrmann T, Riphaus A, Eckardt AJ, Klare P, Kopp I, von Delius S, Rosien U, Tonner PH; Collaborators. Aktualisierte S3-Leitlinie "Sedierung in der gastrointestinalen Endoskopie" der Deutschen Gesellschaft fur Gastroenterologie, Verdauungs- und Stoffwechselkrankheiten (DGVS). Z Gastroenterol. 2023 Sep;61(9):1246-1301. doi: 10.1055/a-2124-5333. Epub 2023 Sep 7. No abstract available. German.
PubMed 37678315