Dexmedetomidine vs Propofol in High-Risk ERCP Patients

NCT07166614 | Recruiting

• 1 other identifier: turk-25
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Respiratory Depression; Hypoxemia; Hypotension Drug-Induced; Bradycardia

Keywords

Dexmedetomidine; propofol; adverse event; ERCP

Outcome Measures

Primary Outcomes (4)

• heart rate

  heart rate

  during the endoscopy (30-60 minute)

• arterial blood pressure

  arterial blood pressure

  during the endoscopy (30-60 minute)

• oxygen saturation

  oxygen saturation

  during the endoscopy (30-60 minute)

• end-tidal CO₂

  end-tidal CO₂

  during the endoscopy (30-60 minute)

Study Arms (2)

group d

EXPERIMENTAL

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

Drug: dexmedetomidin

group p

ACTIVE COMPARATOR

In our ERCP unit, induction was performed according to the standard protocol using fentanyl 1 µg/kg and propofol 1 mg/kg.

Drug: Propofol

Interventions

dexmedetomidin DRUG

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

group d

Propofol DRUG

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

group p

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sisli Hamidiye Etfal Training and Research Hospital: lead

Study Sites (1)

Sisli etfal research and training hospital

Sarıyer, Istanbul, 34371, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency; Hypoxia; Hypotension; Bradycardia

Interventions

Dexmedetomidine; Propofol

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

SEBNEM TURK

CONTACT

+90 532 443 25 44; hacersebnem@yahoo.com.tr

MUSTAFA ALTINAY

CONTACT

05333914422; m_altinay@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: September 10, 2025
• Study Start: September 3, 2025
• Primary Completion: December 30, 2025
• Study Completion: January 15, 2026
• Last Updated: September 10, 2025

Record last verified: 2025-09

Locations

TU (1)