[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658895":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":39,"studyPopulation":25,"armGroups":40,"interventions":53,"overallOfficials":62,"centralContacts":66,"locations":71,"responsibleParty":86,"collaborators":25,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":25,"eligibilityCriteria":95,"healthyVolunteers":91,"sex":96,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":25,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":109,"overallStatus":74,"whyStopped":25,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Pamukkale University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":25},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of Cough During Tracheal Extubation","Cough will be assessed during tracheal extubation. The presence or absence of cough will be recorded for each participant. Cough severity will also be graded using a 4-point cough scale, with higher scores indicating more severe coughing.","During tracheal extubation",[14,18,22],{"measure":15,"description":16,"timeFrame":17},"Hemodynamic Response During Extubation","Heart rate will be recorded to evaluate the hemodynamic response to tracheal extubation.","Before extubation, at extubation, and at 1 and 5 minutes after extubation",{"measure":19,"description":20,"timeFrame":21},"Incidence of Postoperative Sore Throat","Postoperative sore throat will be assessed using a 4-point severity scale: 0 = no sore throat, 1 = mild sore throat, 2 = moderate sore throat, and 3 = severe sore throat. Postoperative sore throat will be defined as a score ≥1.","At 1 hours and 24 hours after surgery",{"measure":23,"description":24,"timeFrame":21},"Incidence of Postoperative Hoarseness","Postoperative hoarseness will be assessed using a 4-point severity scale: 0 = no hoarseness, 1 = mild hoarseness, 2 = moderate hoarseness, and 3 = severe hoarseness. Postoperative hoarseness will be defined as a score ≥1.",null,{"allocation":27,"interventionModel":28,"interventionModelDescription":29,"primaryPurpose":30,"observationalModel":25,"timePerspective":25,"maskingInfo":31},"RANDOMIZED","PARALLEL","Participants will be randomly assigned in a 1:1 ratio to one of two parallel treatment groups: remifentanil alone or remifentanil combined with intravenous lidocaine.","PREVENTION",{"masking":32,"maskingDescription":33,"whoMasked":34},"QUADRUPLE","An independent unblinded researcher will prepare identical syringes labeled \"Study Drug\" according to the randomization list. Participants, anesthesia care providers, investigators, and outcome assessors will be blinded to group allocation. The person preparing the study medication will not participate in perioperative management or outcome assessment.",[35,36,37,38],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","Tracheal extubation may be associated with coughing and hemodynamic responses, which may be undesirable after thyroid surgery. Pharmacological strategies such as remifentanil and intravenous lidocaine may attenuate airway reflexes during emergence from general anesthesia.\n\nThis prospective, randomized, double-blind, parallel-group study is designed to evaluate whether the addition of intravenous lidocaine to remifentanil improves the quality of tracheal extubation compared with remifentanil alone in patients undergoing elective thyroidectomy.\n\nSixty adult patients will be randomly allocated in a 1:1 ratio to receive either remifentanil alone or remifentanil combined with intravenous lidocaine during emergence from anesthesia. Extubation conditions, coughing, hemodynamic variables, respiratory events, recovery characteristics, and postoperative airway-related symptoms will be evaluated.",[41,47],{"label":42,"type":43,"description":44,"interventionNames":45},"remifentanil group","ACTIVE_COMPARATOR","Remifentanil will be administered intravenously at 0.02-0.06 µg\u002Fkg\u002Fmin during anesthesia and titrated according to the study protocol during the emergence period.",[46],"Drug: remifentanil",{"label":48,"type":49,"description":50,"interventionNames":51},"lidocaine-remifentanil","EXPERIMENTAL","Participants assigned to this group will receive remifentanil according to the same study protocol and intravenous lidocaine 1.5 mg\u002Fkg as a slow bolus over 1-2 minutes during surgical dressing before tracheal extubation.",[46,52],"Drug: Lidocaine %2 ampoule",[54,58],{"type":55,"name":56,"description":44,"armGroupLabels":57,"otherNames":25},"DRUG","remifentanil",[48,42],{"type":55,"name":59,"description":60,"armGroupLabels":61,"otherNames":25},"Lidocaine %2 ampoule","Lidocaine 1.5 mg\u002Fkg will be administered intravenously as a slow bolus over 1-2 minutes during surgical dressing before tracheal extubation.",[48],[63],{"name":64,"affiliation":5,"role":65},"saadet nur YALCIN SATICI","PRINCIPAL_INVESTIGATOR",[67],{"name":64,"role":68,"phone":69,"phoneExt":25,"email":70},"CONTACT","+905066474672","yalcinsaadetnur@gmail.com",[72],{"facility":73,"status":74,"city":75,"state":25,"zip":25,"country":76,"countryCode":25,"cosmosGeoPoint":77,"geoPoint":82,"contacts":83},"Pamukkale University Hospitals","RECRUITING","Denizli","Turkey (Türkiye)",{"type":78,"coordinates":79},"Point",[80,81],29.0875,37.77417,{"lat":81,"lon":80},[84],{"name":85,"role":68,"phone":69,"phoneExt":25,"email":70},"SAADET NUR YALCIN SATICI",{"type":65,"investigatorFullName":87,"investigatorTitle":88,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"saadet nur yalçın satıcı","Research Assistant, Department of Anesthesiology and Reanimation","100658895","phase-4-remifentanil-versus-remifentanil-lidocaine-for-tracheal-extubation-after-thyroidectomy-100658895",false,"NCT07857356","Remifentanil Versus Remifentanil-Lidocaine for Tracheal Extubation After Thyroidectomy","Comparison of the Effects of Remifentanil and Remifentanil-Lidocaine Combination on Tracheal Extubation Quality in Patients Undergoing Thyroidectomy","Inclusion Criteria:\n\n* Age 18 to 65 years American Society of Anesthesiologists (ASA) physical status I or II Scheduled for elective thyroidectomy under general anesthesia Body mass index (BMI) \\\u003C35 kg\u002Fm² Able to provide written informed consent\n\nExclusion Criteria:\n\n* History of chronic respiratory disease, including asthma or chronic obstructive pulmonary disease (COPD) Active upper or lower respiratory tract infection Known airway abnormality or anticipated difficult airway Known allergy or hypersensitivity to lidocaine Planned postoperative intubation or extubation in the intensive care unit Refusal to participate or withdrawal of consent","ALL","18 Years","65 Years",{"count":100,"type":101},60,"ESTIMATED","INTERVENTIONAL",[104],"PHASE4","This randomized, double-blind clinical trial will compare the effects of remifentanil alone and remifentanil combined with intravenous lidocaine on the quality of tracheal extubation in adult patients undergoing elective thyroidectomy under general anesthesia.\n\nA total of 60 patients will be randomly assigned to two groups. Both groups will receive remifentanil during emergence from anesthesia, while one group will additionally receive intravenous lidocaine before extubation.\n\nThe primary outcome will be the incidence of coughing during tracheal extubation. Secondary outcomes will include cough severity, hemodynamic responses, oxygen saturation, airway-related adverse events, postoperative sore throat, hoarseness, postoperative nausea and vomiting, sedation level, and recovery and extubation times.",[107,108],"Tracheal Extubation","Cough",[110,111,112,107,108,113],"Thyroidectomy","Remifentanil","Lidocaine","Emergence From Anesthesia","2026-10-07",{"date":116,"type":117},"2026-10-08","ACTUAL",{"date":119,"type":101},"2026-10",{"date":121,"type":101},"2026-11",{"name":5,"class":6},1]