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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• patients over 18 years of age

• ASA physical status III-IV

• scheduled for ERCP in the Gastroenterology Endoscopy Unit of our hospital

Locations
Other Locations
Turkey
Sisli etfal research and training hospital
RECRUITING
Sarıyer
Contact Information
Primary
SEBNEM TURK
hacersebnem@yahoo.com.tr
+90 532 443 25 44
Backup
MUSTAFA ALTINAY
m_altinay@yahoo.com
05333914422
Time Frame
Start Date: 2025-09-03
Estimated Completion Date: 2026-01-15
Participants
Target number of participants: 2
Treatments
Experimental: group d
A loading dose of dexmedetomidine at 1 μg/kg was administered over 10 minutes prior to the procedure. During the procedure, an infusion at 0.5 μg/kg/h was maintained, which was discontinued at the end of the procedure
Active_comparator: group p
In our ERCP unit, induction was performed according to the standard protocol using fentanyl 1 µg/kg and propofol 1 mg/kg.
Sponsors
Leads: Sisli Hamidiye Etfal Training and Research Hospital

This content was sourced from clinicaltrials.gov