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

Comparison of Advanced Hemodynamic Monitoring With Standard Monitoring During Propofol Sedation for Endoscopic Retrograde Cholangiopancreatography Procedures: A Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Hemodynamic Instability
• Intervention / Treatment: Procedure: Standard Monitoring; Device: Hemodynamic Monitoring

Detailed Description

ERCP is a widely used interventional procedure for the visualization and treatment of biliary and pancreatic duct disorders. Compared with surgery, it is less invasive and provides an effective therapeutic alternative. Although its diagnostic use has declined with the increasing availability of less invasive imaging modalities, ERCP is still frequently performed for therapeutic purposes such as relieving biliary or pancreatic obstruction, placing stents, and obtaining tissue samples. The need for ERCP is particularly increasing in elderly patients due to biliary stones and malignant obstruction. In this population, sepsis, hemodynamic fragility, and accompanying comorbidities make anesthesia and sedation management more challenging during the procedure.

The primary goal of perioperative hemodynamic management is to maintain adequate organ perfusion and oxygen delivery. Although blood pressure is routinely monitored in clinical practice, parameters such as cardiac output, stroke volume, systemic vascular resistance, and afterload may provide a more comprehensive understanding of the mechanisms underlying hemodynamic status. A normal mean arterial pressure alone does not necessarily indicate adequate cardiac output or tissue perfusion. Therefore, some hemodynamic disturbances may remain undetected in patients assessed with standard monitoring alone.

Advanced hemodynamic monitoring methods allow continuous assessment of parameters such as cardiac output, stroke volume, systemic vascular resistance, arterial elastance, and cardiac power output through arterial waveform analysis. The MostCare system, using PRAM technology, can obtain these data from the invasive arterial pressure waveform without requiring external calibration. By providing a more detailed evaluation of the causes of hemodynamic instability, it may facilitate more targeted and timely interventions.

The aim of this study is to evaluate whether advanced hemodynamic monitoring with MostCare provides an advantage over standard monitoring alone in the detection and management of hemodynamic events requiring intervention in patients undergoing ERCP under propofol sedation. In addition, the study seeks to clarify the potential clinical contribution of advanced monitoring in interventional procedures performed under sedation.

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sibel Onen Ozdemir, MD; Phone Number: +905442892194; Email: sibelonen89@gmail.com

Study Locations

• Turkey (Türkiye)
  • Çorum, Turkey (Türkiye)
    • Recruiting
    • Hitit University
    • Contact: Ozgur Yagan, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Study Population

The study population consists of adult patients with ASA physical status III or higher who are scheduled for elective ERCP and managed under propofol sedation while maintaining spontaneous respiration in a single-center tertiary care university hospital setting.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 1 Arm Title: Standard Monitoring Group; 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; Standard intra-procedural monitoring including non-invasive blood pressure, ECG, pulse oximetry, and BIS during ERCP under propofol sedation
Experimental: Arm 2 Arm Title: Advanced Hemodynamic Monitoring Group; 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; Advanced hemodynamic monitoring performed using the MostCare system via radial arterial cannulation during ERCP under propofol sedation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hitit University
• Investigators: Study Chair: Ozgur Yagan, Professor, Hitit University

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2026
• Primary Completion (Actual): April 25, 2026
• Study Completion (Estimated): July 15, 2026

Study Registration Dates

• First Submitted: April 13, 2026
• First Submitted That Met QC Criteria: April 13, 2026
• First Posted (Actual): April 20, 2026

Study Record Updates

• Last Update Posted (Actual): June 24, 2026
• Last Update Submitted That Met QC Criteria: June 19, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: ERCP; Sedation; Propofol; Non-operating room anesthesia; Advenced hemodynamic Monitorization
• Additional Relevant MeSH Terms: Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Cardiovascular; Monitoring, Physiologic; Hemodynamic Monitoring
• Other Study ID Numbers: 2026-04

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No