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Opioid-Free Versus Opioid-Based Sedation for Endoscopic Procedures
Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Summary
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.
Official title: Evaluation of an Opioid-Free Approach in Sedation Method Selection in Endoscopy Units: A Prospective Randomized Observational Double-Blind Comparison of Dexmedetomidine (Opioid-Free) and Remifentanil-Dexmedetomidine (Opioid-Based) Combination
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2026-06
Completion Date
2028-02
Last Updated
2026-06-16
Healthy Volunteers
No
Interventions
Dexmedetomidine
Dexmedetomidine 200 mcg diluted in 100 mL isotonic saline and administered according to the study protocol.
Remifentanil
Remifentanil 5 mg diluted in 100 mL isotonic saline and administered according to the study protocol.