[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639198":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":19,"locations":10,"responsibleParty":25,"collaborators":10,"id":29,"slug":30,"hasResults":31,"nctId":32,"briefTitle":33,"officialTitle":34,"acronym":10,"eligibilityCriteria":35,"healthyVolunteers":36,"sex":37,"minAge":38,"maxAge":39,"enrollmentInfo":40,"targetDuration":10,"studyType":43,"phases":10,"briefSummary":44,"conditions":45,"keywords":49,"overallStatus":60,"whyStopped":10,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":10},{"fullName":5,"class":6},"Gaziantep City Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients Undergoing Extubation After General Anesthesia",null,"Adult patients undergoing elective surgery under general anesthesia who are planned for extubation in the operating room will be prospectively observed. Before extubation, RSBI, TOF ratio, and BIS values will be recorded. The decision to extubate will be made by the attending anesthesiologist according to routine clinical practice and will not be altered by the study protocol.",[13],"Other: Combined pre-extubation assessment using RSBI, TOF ratio, and BIS",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":10},"Combined pre-extubation assessment using RSBI, TOF ratio, and BIS","RSBI, TOF ratio, and BIS values will be recorded immediately before extubation as part of the study assessment. RSBI will be calculated using respiratory rate and tidal volume. TOF ratio will be used to assess neuromuscular recovery, and BIS will be used to assess the level of consciousness. These measurements will be evaluated for their predictive value for extubation success. The study protocol will not determine or alter the extubation decision.",[9],[20],{"name":21,"role":22,"phone":23,"phoneExt":10,"email":24},"Muhammed Gökhan Abay, MD","CONTACT","+905379479745","abay.25@gmail.com",{"type":26,"investigatorFullName":27,"investigatorTitle":28,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Muhammed Gökhan Abay","Specialist Physician in Anesthesiology and Reanimation","100639198","combined-rsbi-tof-and-bis-for-prediction-of-extubation-success-100639198",false,"NCT07577453","Combined RSBI, TOF, and BIS for Prediction of Extubation Success","Predictive Value of Combined RSBI, TOF, and BIS Monitoring for Extubation Success After General Anesthesia","Inclusion Criteria:\n\n* Age between 18 and 80 years\n* ASA physical status I-III\n* Patients scheduled for elective surgery under general anesthesia\n* Patients undergoing endotracheal intubation during general anesthesia\n* Patients receiving neuromuscular blocking agents during anesthesia\n* Patients planned for extubation in the operating room\n* Availability of pre-extubation RSBI, TOF ratio, and BIS measurements\n* Written informed consent obtained from the patient\n\nExclusion Criteria:\n\n* Emergency surgery\n* Age \\\u003C18 years or \\>80 years\n* ASA physical status IV or higher\n* Known or anticipated difficult airway\n* Anticipated difficult extubation\n* Preoperative mechanical ventilation\n* Planned postoperative mechanical ventilation or transfer to the intensive care unit while intubated\n* Known neuromuscular disease\n* Severe chronic respiratory failure\n* Severe chronic obstructive pulmonary disease associated with respiratory failure\n* Significant neurological disease affecting respiratory drive or level of consciousness\n* Conditions or medications that may interfere with reliable neuromuscular monitoring\n* Inability to obtain reliable RSBI, TOF ratio, or BIS measurements\n* Refusal to participate\n* Incomplete perioperative or post-extubation outcome data",true,"ALL","18 Years","80 Years",{"count":41,"type":42},150,"ESTIMATED","OBSERVATIONAL","This prospective observational study aims to evaluate the predictive value of the combined use of the rapid shallow breathing index, train-of-four ratio, and bispectral index for extubation success after general anesthesia. Adult patients undergoing elective surgery under general anesthesia and planned for extubation in the operating room will be included.\n\nBefore extubation, RSBI, TOF ratio, BIS value, respiratory parameters, and relevant perioperative data will be recorded. The decision to extubate will be made by the attending anesthesiologist according to routine clinical practice and will not be altered by the study protocol. Patients will be followed for 30 minutes after extubation to assess extubation success or the development of complications such as desaturation, laryngospasm, need for airway intervention, mask ventilation, or reintubation.\n\nThe primary aim is to determine whether the combined RSBI, TOF, and BIS model predicts extubation success more accurately than each parameter alone.",[46,47,48],"Extubation Success","Extubation Failure","Postoperative Respiratory Complications",[50,51,52,53,54,55,56,57,58,59],"Extubation","Extubation Succcess","Extubation failure","General anesthesia","Rapid shallow breathing index","TOF ratio","Bispectral index","Neuromuscular monitoring","Postoperative respiratory complications","Prediction model","NOT_YET_RECRUITING","2026-05-09",{"date":63,"type":64},"2026-05-13","ACTUAL",{"date":66,"type":42},"2026-06-15",{"date":68,"type":42},"2026-08-15",{"name":5,"class":6}]