drugset / Trial / NCT07166614

Dexmedetomidine vs Propofol in High-Risk ERCP Patients

NCT07166614 ↗

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2025-09-03
Primary completion
2026-02-28
Completion
2026-04-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexmedetomidine Other / unclassified 0.5 ug/kg —
Comparator Propofol Small molecule 1 mg/kg Intravenous