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

Inclusion Criteria3

patients over 18 years of age
ASA physical status III-IV
scheduled for ERCP in the Gastroenterology Endoscopy Unit of our hospital

Exclusion Criteria5

pregnant women;
patients with neuropsychiatric disease,
substance abuse, or known allergy to the sedatives used;
patients with baseline heart rate ≤50 bpm;
those who did not provide consent.

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