Advanced vs Standard Hemodynamic Monitoring During Propofol Sedation for ERCP: A Prospective Study

NCT07538115 | Recruiting

• 1 other identifier: 2026-04
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate whether there is a difference in hemodynamic events requiring intervention between patients monitored with advanced hemodynamic monitoring using the MostCare system and those monitored with standard monitoring alone during propofol sedation for ERCP procedures.

Conditions

Hemodynamic Instability

Keywords

Advenced hemodynamic Monitorization; ERCP; Sedation; Propofol; Non-operating room anesthesia

Outcome Measures

Primary Outcomes (1)

• Number of hemodynamic events requiring clinical intervention during ERCP under propofol sedation

  Hemodynamic events requiring intervention, including hypotension (MAP \<65 mmHg), bradycardia (HR \<50 bpm), hypoxemia (SpO₂ \<92%), or sedation-depth abnormalities requiring treatment adjustment, will be recorded and compared between groups

  From the start of sedation until the end of the ERCP procedure

Study Arms (2)

Arm 1 Arm Title: Standard Monitoring Group

ACTIVE COMPARATOR

Patients allocated to the standard monitoring group will receive routine monitoring during ERCP sedation, including non-invasive blood pressure, electrocardiography, peripheral oxygen saturation, and bispectral index monitoring. Sedation will be provided with midazolam and propofol according to the study protocol.

Procedure: Standard Monitoring

Arm 2 Arm Title: Advanced Hemodynamic Monitoring Group

EXPERIMENTAL

Patients allocated to the advanced hemodynamic monitoring group will receive standard monitoring plus advanced hemodynamic monitoring using arterial waveform analysis during ERCP sedation. Advanced hemodynamic parameters such as cardiac output, cardiac index, stroke volume, stroke volume index, systemic vascular resistance, and cardiac cycle efficiency will be recorded and used for hemodynamic assessment.

Device: Hemodynamic Monitoring

Interventions

Standard Monitoring PROCEDURE

Standard intra-procedural monitoring including non-invasive blood pressure, ECG, pulse oximetry, and BIS during ERCP under propofol sedation

Arm 1 Arm Title: Standard Monitoring Group

Hemodynamic Monitoring DEVICE

Advanced hemodynamic monitoring performed using the MostCare system via radial arterial cannulation during ERCP under propofol sedation.

Arm 2 Arm Title: Advanced Hemodynamic Monitoring Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years and older
• Patients with an ASA physical status score of III or higher scheduled for ERCP
• Patients maintaining spontaneous respiration
• Patients who have provided written informed consent

You may not qualify if:

• Patients requiring general anesthesia
• Patients requiring mechanical ventilation
• Patients unsuitable for arterial catheterization due to coagulopathy or local infection
• Pregnant women
• Patients who do not sign the informed consent form

Sponsors & Collaborators

• Hitit University: lead

Study Sites (1)

Hitit university

Çorum, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Hemodynamic Monitoring

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Monitoring, Physiologic

Study Officials

• Ozgur Yagan, Professor

  Hitit University

  STUDY CHAIR

Central Study Contacts

Sibel Onen Ozdemir, MD

CONTACT

+905442892194; sibelonen89@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the monitoring interventions, the attending anesthesiologist cannot be blinded to group allocation. Outcome assessors may be blinded during data extraction and statistical analysis when feasible.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: April 20, 2026
• Study Start: March 27, 2026
• Primary Completion: April 25, 2026
• Study Completion: July 15, 2026
• Last Updated: June 24, 2026

Record last verified: 2026-06

Locations

TU (1)