[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643045":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":26,"responsibleParty":40,"collaborators":26,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":26,"eligibilityCriteria":50,"healthyVolunteers":46,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":26,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":66,"overallStatus":68,"whyStopped":26,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":26},{"fullName":5,"class":6},"Bakirkoy Dr. Sadi Konuk Research and Training Hospital","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Dexmedetomidine (Opioid-Free)","EXPERIMENTAL","Participants will receive dexmedetomidine infusion for procedural sedation. Dexmedetomidine infusion will be initiated at 0.7 mcg\u002Fkg\u002Fh. Five minutes later, a placebo infusion (100 mL isotonic saline) will be started. Sedation will be induced with propofol 1.5 mg\u002Fkg IV bolus and maintained according to the study protocol.",[13],"Drug: Dexmedetomidine",{"label":15,"type":16,"description":17,"interventionNames":18},"Remifentanil + Dexmedetomidine","ACTIVE_COMPARATOR","Participants will receive dexmedetomidine infusion at 0.7 mcg\u002Fkg\u002Fh. Five minutes later, remifentanil infusion will be initiated at 0.01-0.03 mcg\u002Fkg\u002Fmin. Sedation will be induced with propofol 1.5 mg\u002Fkg IV bolus and maintained according to the study protocol.",[13,19],"Drug: Remifentanil",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Dexmedetomidine","Dexmedetomidine 200 mcg diluted in 100 mL isotonic saline and administered according to the study protocol.",[9,15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Remifentanil","Remifentanil 5 mg diluted in 100 mL isotonic saline and administered according to the study protocol.",[15],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Tuğba Yücel Yenice, MD","CONTACT","+90 212 414 71 71","tugbayucel09@gmail.com",{"name":38,"role":34,"phone":35,"phoneExt":26,"email":39},"Sevim Bahar Bedirhan, MD","sbbedirhan@gmail.com",{"type":41,"investigatorFullName":42,"investigatorTitle":43,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Nalan Saygi Emir","Associate Professor","100643045","opioid-free-versus-opioid-based-sedation-for-endoscopic-procedures-100643045",false,"NCT07649746","Opioid-Free Versus Opioid-Based Sedation for Endoscopic Procedures","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","Inclusion Criteria:\n\n* Age 18 to 85 years\n* ASA physical status I-III\n* Scheduled for ERCP, gastroscopy, or colonoscopy\n\nExclusion Criteria:\n\n* Refusal to participate in the study\n* Inability to communicate\n* Alcohol or substance abuse\n* Neuropsychiatric disease\n* Severe respiratory failure\n* Severe heart failure\n* Pregnancy\n* Body mass index (BMI) \\>30 kg\u002Fm²\n* Hearing impairment\n* History of allergy to study medications\n* Requirement for orotracheal intubation or general anesthesia\n* Procedures lasting less than 20 minutes","ALL","18 Years","85 Years",{"count":55,"type":56},80,"ESTIMATED","INTERVENTIONAL",[59],"NA","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).\n\nThe 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.",[62,63,64,65],"Sedation","Endoscopy","Colonoscopy","Endoscopic Retrograde Cholangiopancreatography (ERCP)",[23,67,28,62,63],"Opioid-Free Sedation","NOT_YET_RECRUITING","2026-06-10",{"date":71,"type":72},"2026-06-16","ACTUAL",{"date":74,"type":56},"2026-06",{"date":76,"type":56},"2028-02",{"name":5,"class":6}]