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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHitit University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients requiring general anesthesia

Patients requiring mechanical ventilation

Patients unsuitable for arterial catheterization due to coagulopathy or local infection

Pregnant women

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hemodynamic Monitoring

    Device

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

  • Standard Monitoring

    Procedure/Surgery

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

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: Arm 1 Arm Title: Standard Monitoring GroupActive comparator 1 intervention
Group B: Arm 2 Arm Title: Advanced Hemodynamic Monitoring GroupExperimental treatment 1 intervention

Trial outcomes

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

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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