Opioid-Free Versus Opioid-Based Sedation for Endoscopic Procedures

Overview

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.

Safe and comfortable sedation is essential for endoscopic procedures performed outside the operating room. Various sedation strategies have been developed to improve patient safety, procedural conditions, and recovery profiles. Opioids are commonly used as part of sedation regimens; however, opioid administration may be associated with adverse symptoms such as nausea, vomiting, dizziness, drowsiness, difficulty concentrating, fatigue, pruritus, dry mouth, and headache. This prospective randomized double-blind study will compare dexmedetomidine alone (opioid-free approach) with a combination of dexmedetomidine and remifentanil (opioid-based approach) for sedation during gastroscopy, colonoscopy, and endoscopic retrograde cholangiopancreatography (ERCP). Eighty ASA physical status I-III patients aged 18-80 years will be enrolled at a single center. Participants will be randomly assigned to one of two study groups using a computer-generated randomization sequence. Study medications will be prepared by an independent anesthesiologist to maintain blinding. In both groups, dexmedetomidine infusion will be administered. The comparison group will additionally receive remifentanil infusion according to the study protocol. The primary objective is to determine whether the opioid-free approach reduces the incidence of opioid-related adverse symptoms. Secondary objectives include evaluation of postoperative quality of recovery using the QoR-15 questionnaire and assessment of patient, surgeon, and recovery nurse satisfaction. Additional outcomes include hemodynamic parameters, sedation scores, pain scores, rescue analgesic requirements, discharge time, post-anesthesia care unit requirements, and procedure- or anesthesia-related complications.