Opioid-Free Versus Opioid-Based Sedation for Endoscopic Procedures

Starting soon · Not applicable

Conditions studied: Sedation, Endoscopy, Colonoscopy, Endoscopic Retrograde Cholangiopancreatography (ERCP)

In brief

This study will compare two different sedation approaches used during gastroscopy, colonoscopy, and endoscopic retrograde cholangiopancreatography (ERCP). One group will receive dexmedetomidine alone (opioid-free sedation), while the other group will receive dexmedetomidine combined with remifentanil (opioid-based sedation). The purpose of the study is to determine whether an opioid-free sedation approach can reduce opioid-related adverse symptoms, such as nausea, vomiting, dizziness, drowsiness, dry mouth, headache, and fatigue. The study will also evaluate quality of recovery, patient and healthcare staff satisfaction, hemodynamic effects, complications, and time to discharge after the procedure.

Key facts

Study ID

NCT07649746

Run by

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

People needed

80

Starts

2026-06-01

Expected to finish

2028-02-01

Last updated by the study team

2026-06-16

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 to 85 years
• ASA physical status I-III
• Scheduled for ERCP, gastroscopy, or colonoscopy

You may not qualify if…

• Refusal to participate in the study
• Inability to communicate
• Alcohol or substance abuse
• Neuropsychiatric disease
• Severe respiratory failure
• Severe heart failure
• Pregnancy
• Body mass index (BMI) >30 kg/m²
• Hearing impairment
• History of allergy to study medications
• Requirement for orotracheal intubation or general anesthesia
• Procedures lasting less than 20 minutes

Full record on ClinicalTrials.gov

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