[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Filiz Kaya\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":51},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":34,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":5},"100655553","opioid-free-anesthesia-in-fess-a-prospective-eras-study-100655553",false,"NCT07812389","Opioid-Free Anesthesia in FESS: A Prospective ERAS Study","Opioid-Free Anesthesia in Functional Endoscopic Sinus Surgery: Effects on Perioperative Outcomes - A Prospective Observational ERAS Study","OFA-FESS","Inclusion Criteria:\n\n* Patients aged between 18 and 65 years.\n* American Society of Anesthesiologists (ASA) physical status I or II.\n* Patients scheduled for elective Functional Endoscopic Sinus Surgery (FESS) due to chronic sinusitis.\n* Patients whose perioperative care is managed strictly according to institutional Enhanced Recovery After Surgery (ERAS) principles.\n* Both female and male patients are eligible for inclusion.\n\nExclusion Criteria:\n\n* Known cardiac conduction abnormalities or arrhythmias.\n* History of chronic opioid use or opioid dependency.\n* Current use of beta-blockers or antiarrhythmic medications.\n* Severe hepatic or renal impairment.\n* Obesity defined as a Body Mass Index (BMI) greater than 35 kg\u002Fm².\n* Current use of GLP-1 receptor agonists.\n* Documented coagulopathy or bleeding disorders.\n* History of prior revision Functional Endoscopic Sinus Surgery (FESS) procedures.\n* History of delayed gastric emptying or high risk of pulmonary aspiration.","ALL","18 Years","65 Years",{"count":21,"type":22},104,"ESTIMATED","OBSERVATIONAL","1. Information for Patients and Families What is this study about? When patients undergo functional endoscopic sinus surgery (FESS), strong pain relievers called opioids are traditionally used during anesthesia. While effective, opioids can sometimes cause unwanted side effects such as nausea, vomiting, dizziness, or prolonged recovery times. This study investigates an \"Opioid-Free Anesthesia\" (OFA) approach combined with Enhanced Recovery After Surgery (ERAS) protocols. ERAS is a modern, science-based care pathway designed to help patients recover faster and more comfortably after surgery.\n\n   Why is this study important? The goal of this study is to see if skipping opioids during sinus surgery-and using alternative pain-management techniques instead-leads to better perioperative outcomes. We want to find out if patients experience less pain, fewer side effects (like nausea), and a quicker, safer return to their daily routines.\n\n   What will happen if you participate? If you fit the criteria and agree to join, your surgical journey will follow the standard ERAS protocol, but your anesthesia will be managed without conventional opioid medications. Researchers will closely monitor your comfort, pain levels, and recovery speed before, during, and after your sinus surgery.\n2. Technical Summary for Health Care Providers Official Study Title: Opioid-Free Anesthesia in Functional Endoscopic Sinus Surgery: Effects on Perioperative Outcomes - A Prospective Observational ERAS Study Study Rationale and Objective: Traditional opioid-based anesthesia is often associated with opioid-induced side effects (OIAEs) such as postoperative nausea and vomiting (PONV), respiratory depression, and delayed discharge. This prospective observational study aims to evaluate the clinical impact of Opioid-Free Anesthesia (OFA) embedded within an Enhanced Recovery After Surgery (ERAS) pathway for patients undergoing elective Functional Endoscopic Sinus Surgery (FESS). The primary focus is to assess whether an OFA-ERAS strategy optimizes perioperative outcomes, stabilizes intraoperative hemodynamics, and minimizes recovery times compared to historical opioid-based standards.\n\nStudy Design: Prospective, Observational Study. Estimated Enrollment: 104 patients. Setting: Perioperative tracking following strict institutional ERAS principles.",[26,27,28,29,30,31,32,33],"Chronic Sinusitis","Postoperative Pain","Postoperative Nausea and Vomiting (PONV)","Surgical Field Visibility","Enhanced Recovery After Surgery (ERAS) Protocol","Blood Loss, Surgical","Opioid-free Anesthesia","Functional Endoscopic Sinus Surgery (FESS)",[35,36,37,38,29,31,27],"Opioid-Free Anesthesia","Functional Endoscopic Sinus Surgery","Postoperative Nausea and Vomiting","Enhanced Recovery After Surgery","RECRUITING","2026-09-04",{"date":42,"type":43},"2026-09-10","ACTUAL",{"date":45,"type":43},"2026-08-15",{"date":47,"type":22},"2027-09-15",{"name":49,"class":50},"Filiz Kaya","OTHER",""]