RecruitingNot ApplicableNCT07166614

Dexmedetomidine vs Propofol in High-Risk ERCP Patients

Comparison of Respiratory and Hemodynamic Effects of Dexmedetomidine vs. Propofol in High-Risk Patients Undergoing ERCP: A Prospective Randomized Controlled Study

Sponsor

Sisli Hamidiye Etfal Training and Research Hospital

Enrollment

2 participants

Start Date

Sep 3, 2025

Study Type

INTERVENTIONAL

Conditions

Hypoxemia Bradycardia Respiratory Depression Hypotension Drug-Induced

Summary

ERCP requires deep sedation due to pain and discomfort, but propofol-commonly used with opioids-often causes respiratory and cardiovascular complications, especially in elderly or high-risk patients. Dexmedetomidine offers sedation without respiratory depression but may lower blood pressure and heart rate. Current monitoring often relies only on SpO₂, while capnography and the Integrated Pulmonary Index (IPI) provide earlier detection of respiratory events but are underused in ERCP studies. This study compares dexmedetomidine and propofol in high-risk ERCP patients, focusing on respiratory and hemodynamic effects, propofol consumption, recovery, and discharge times. The hypothesis is that dexmedetomidine will cause fewer adverse respiratory and hemodynamic effects.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two sedation medications — dexmedetomidine and propofol — in high-risk patients undergoing a procedure called ERCP (endoscopic retrograde cholangiopancreatography), which examines the bile ducts and pancreas using a flexible scope. The goal is to find out which sedative is safer and more effective for patients who are sicker or older. **You may be eligible if...** - You are over 18 years old - You are classified as high-risk (ASA physical status III or IV — meaning you have significant medical conditions) - You are scheduled for an ERCP procedure at the study hospital's gastroenterology unit **You may NOT be eligible if...** - You are pregnant - You have a neurological or psychiatric disorder - You have a history of substance abuse - You have a known allergy to the sedative medications being studied - Your resting heart rate is 50 beats per minute or lower - You do not provide consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGdexmedetomidin

Dexmedetomidine is a highly selective α2-adrenergic receptor agonist with sedative, anxiolytic, and analgesic properties. Unlike many other sedatives, it provides sedation without significant respiratory depression, though it may cause bradycardia and hypotension

DRUGPropofol

Propofol is a short-acting intravenous anesthetic agent widely used for induction and maintenance of anesthesia as well as procedural sedation. It provides rapid onset and recovery, but is associated with respiratory depression and hypotension