[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655553":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":36,"studyPopulation":37,"armGroups":38,"interventions":49,"overallOfficials":59,"centralContacts":64,"locations":70,"responsibleParty":91,"collaborators":32,"id":95,"slug":96,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":97,"sex":103,"minAge":104,"maxAge":105,"enrollmentInfo":106,"targetDuration":32,"studyType":109,"phases":32,"briefSummary":110,"conditions":111,"keywords":120,"overallStatus":73,"whyStopped":32,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},{"fullName":5,"class":6},"Ankara City Hospital Bilkent","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":32},[9],{"measure":10,"description":11,"timeFrame":12},"Quality of the Surgical Field Assessed by Fromme-Boezaart Scoring System","Comparison of the surgical field quality between the Opioid-Free Anesthesia (OFA) group and the traditional opioid group. The quality of the surgical field visibility will be evaluated by the operating surgeon using a validated visual scoring system, such as the Fromme-Boezaart Surgical Field Scoring System (ranging from 0 = no bleeding to 5 = severe bleeding, where lower scores indicate better surgical conditions).","Perioperative\u002FPeriprocedural",[14,18,21,25,28],{"measure":15,"description":16,"timeFrame":17},"Surgeon Satisfaction Score Assessed by a 5-Point Likert Scale","Assessment of the operating surgeon's overall satisfaction regarding the surgical conditions, field visibility, and patient immobility during the procedure. It will be evaluated using a 5-point Likert scale (ranging from 1 = Very Dissatisfied to 5 = Very Satisfied, where higher scores indicate a higher level of surgeon satisfaction)","Immediately after the completion of the surgical procedure.",{"measure":19,"description":20,"timeFrame":12},"Heart Rate (HR)","Comparison of intraoperative heart rate (measured in beats per minute) between the two study cohorts to evaluate hemodynamic stability. Measurements will be recorded at predefined standard surgical intervals from anesthesia induction until extubation.",{"measure":22,"description":23,"timeFrame":24},"Postoperative Sleep Quality Assessed by Pittsburgh Sleep Quality Index (PSQI)","Evaluation and comparison of the patient's subjective sleep quality during the first postoperative week between the two study cohorts. Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), which ranges from a minimum score of 0 to a maximum score of 21. A higher global score indicates worse sleep quality.","Postoperative Day 7",{"measure":26,"description":27,"timeFrame":12},"Mean Arterial Pressure (MAP)","Comparison of intraoperative mean arterial pressure (measured in mmHg) between the two study cohorts to evaluate hemodynamic stability. Measurements will be recorded at predefined standard surgical intervals from anesthesia induction until extubation.",{"measure":29,"description":30,"timeFrame":31},"Severity of Postoperative Nausea and Vomiting (PONV)","Evaluation and comparison of the severity of postoperative nausea and vomiting between the two study cohorts. The severity of PONV will be assessed using a validated Visual Analog Scale (VAS) scoring system adapted from the literature: 0 = No nausea; 1 = Mild nausea; 2 = Moderate nausea; 3 = Severe nausea\u002Fvomiting. Lower scores indicate a lower burden of opioid-induced emetic side effects.","Postoperative 24 hours",null,{"allocation":32,"interventionModel":32,"interventionModelDescription":32,"primaryPurpose":32,"observationalModel":34,"timePerspective":35,"maskingInfo":32},"COHORT","PROSPECTIVE","This prospective observational study is designed to evaluate perioperative clinical outcomes in patients undergoing elective Functional Endoscopic Sinus Surgery (FESS) under routine clinical care. In accordance with the observational nature of the study, the investigators do not assign or control the anesthetic techniques, drug dosages, or clinical pathways. All perioperative interventions, including the choice between an opioid-free anesthesia (OFA) approach or traditional opioid-based anesthesia, are determined solely by the attending anesthesiologists based on standard institutional protocols and clinical judgment.\n\nData collection will encompass the entire perioperative period, spanning from the pre-anesthesia assessment until the standard post-operative follow-up intervals.\n\nThe clinical tracking workflow consists of the following phases:\n\n1. Preoperative Phase: Eligible patients scheduled for elective FESS due to chronic sinusitis are identified during routine pre-anesthesia visits. Baseline demographic characteristics, physical status according to the American Society of Anesthesiologists (ASA) classification, and relevant medical histories are documented.\n2. Intraoperative Phase: Standard monitoring and depth of anesthesia parameters are recorded in the operating room. Intraoperative hemodynamic data (including heart rate and mean arterial pressure) and parameters related to the surgical field quality are collected at predefined surgical milestones from the initial incision to the completion of the procedure. Total consumption of anesthetic agents and any required vasoactive medications are also logged.\n3. Postoperative Phase: Following extubation, patients are transferred to the Post-Anesthesia Care Unit (PACU). Early recovery characteristics, including recovery times and discharge scores, are monitored. Within the first 24 hours post-surgery, acute postoperative pain scores and the incidence or severity of postoperative nausea and vomiting (PONV) are tracked at serial clinical intervals.\n4. Follow-up Phase: Patient-reported outcomes regarding subjective recovery characteristics, such as postoperative sleep quality, are subsequently evaluated during the routine outpatient follow-up visit at one week postoperatively.\n\nStatistical analyses will be performed to evaluate and compare the collected perioperative datasets between patients who received dexmedetomidine-based opioid-free anesthesia and those who received traditional opioid-based regimens under the institutional Enhanced Recovery After Surgery (ERAS) framework. No additional clinical interventions, blood samplings, or changes to standard patient care pathways are introduced due to study participation.","Adult male and female patients aged 18 to 65 years who are scheduled to undergo elective Functional Endoscopic Sinus Surgery (FESS) due to chronic sinusitis at Ankara Bilkent City Hospital, a tertiary care referral and teaching hospital in Ankara, Turkey. The study population comprises consecutive eligible patients whose perioperative anesthetic and surgical management is monitored following institutional Enhanced Recovery After Surgery (ERAS) pathways.",[39,44],{"label":40,"type":32,"description":41,"interventionNames":42},"OFA Group","Patients undergoing elective Functional Endoscopic Sinus Surgery (FESS) who receive dexmedetomidine-based Opioid-Free Anesthesia (OFA) embedded within an Enhanced Recovery After Surgery (ERAS) pathway. No intraoperative opioids will be administered to this cohort.",[43],"Drug: Dexmedetomidine",{"label":45,"type":32,"description":46,"interventionNames":47},"O Group (Opioid Group)","Patients undergoing elective Functional Endoscopic Sinus Surgery (FESS) who receive traditional remifentanil-based opioid anesthesia embedded within the same Enhanced Recovery After Surgery (ERAS) pathway.",[48],"Drug: Remifentanil",[50,55],{"type":51,"name":52,"description":53,"armGroupLabels":54,"otherNames":32},"DRUG","Dexmedetomidine","Patients in the Opioid-Free Anesthesia (OFA) cohort receive general anesthesia maintained via Total Intravenous Anesthesia (TIVA) with a propofol infusion. Intraoperative analgesia and hemodynamic control are managed using a dexmedetomidine infusion combined with non-opioid multimodal analgesics, embedded within an institutional ERAS pathway. Brain function monitoring (Masimo SedLine®) is used to guide anesthesia depth. No intraoperative systemic opioids are administered.",[40],{"type":51,"name":56,"description":57,"armGroupLabels":58,"otherNames":32},"Remifentanil","Patients in the Opioid (O) cohort receive general anesthesia maintained via Total Intravenous Anesthesia (TIVA) using a propofol infusion. Intraoperative analgesia is provided through a traditional remifentanil-based continuous intravenous infusion protocol, managed within the same institutional ERAS pathway.",[45],[60],{"name":61,"affiliation":62,"role":63},"Filiz Kaya, M.D.","Ankara Bilkent City Hospital, Department of Anesthesiology and Reanimation","PRINCIPAL_INVESTIGATOR",[65],{"name":66,"role":67,"phone":68,"phoneExt":32,"email":69},"Filiz Kaya, M.D","CONTACT","+903125526000","fbulut5@hotmail.com",[71],{"facility":72,"status":73,"city":74,"state":75,"zip":76,"country":77,"countryCode":32,"cosmosGeoPoint":78,"geoPoint":83,"contacts":84},"Ankara Bilkent City Hospital","RECRUITING","Ankara","ÇANKAYA","06800","Turkey (Türkiye)",{"type":79,"coordinates":80},"Point",[81,82],32.85427,39.91987,{"lat":82,"lon":81},[85,88],{"name":86,"role":67,"phone":87,"phoneExt":32,"email":69},"FİLİZ KAYA, M.D.","05056170718",{"name":89,"role":67,"phone":32,"phoneExt":32,"email":90},"Ezgi Erkılıç, Prof.","eerkilic72@yahoo.com",{"type":92,"investigatorFullName":93,"investigatorTitle":94,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"SPONSOR_INVESTIGATOR","Filiz Kaya","M.D.","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":107,"type":108},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.",[112,113,114,115,116,117,118,119],"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)",[121,122,123,124,115,117,113],"Opioid-Free Anesthesia","Functional Endoscopic Sinus Surgery","Postoperative Nausea and Vomiting","Enhanced Recovery After Surgery","2026-09-04",{"date":127,"type":128},"2026-09-10","ACTUAL",{"date":130,"type":128},"2026-08-15",{"date":132,"type":108},"2027-09-15",{"name":93,"class":6},1]