[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656865":3},{"organization":4,"outcomesModule":7,"designInfo":25,"detailedDescription":28,"studyPopulation":29,"armGroups":30,"interventions":39,"overallOfficials":24,"centralContacts":43,"locations":49,"responsibleParty":67,"collaborators":24,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":24,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":24,"studyType":83,"phases":24,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":94,"whyStopped":24,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Istanbul University - Cerrahpasa","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":24},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of Postoperative Residual Neuromuscular Block","Percentage of participants with postoperative residual neuromuscular block (PRNB), defined as a normalized train-of-four (TOF) ratio \\\u003C0.90 measured at the adductor pollicis using TOF-Watch SX neuromuscular monitoring.","At admission to the post-anesthesia care unit (PACU), immediately after extubation",[14,17,21],{"measure":15,"description":16,"timeFrame":12},"Association Between Passive Smoke Exposure and Postoperative Residual Neuromuscular Block, Measured as an Odds Ratio","The association between passive smoke exposure and postoperative residual neuromuscular block (PRNB) will be assessed using an odds ratio (OR). PRNB is defined as a normalized TOF ratio \\\u003C0.90 measured at the adductor pollicis using TOF-Watch SX neuromuscular monitoring. Multivariable logistic regression will be used to estimate the adjusted odds ratio for PRNB associated with passive smoke exposure.",{"measure":18,"description":19,"timeFrame":20},"Association Between Postoperative TOF Ratio and Postoperative Respiratory Complications, Measured as an Odds Ratio","The association between postoperative TOF ratio and postoperative respiratory complications will be assessed. Postoperative respiratory complications will be defined as the occurrence of one or more of the following events during the PACU stay: oxygen saturation (SpO₂) \\\u003C90%, requirement for supplemental oxygen due to hypoxemia, upper airway obstruction requiring intervention, or requirement for assisted ventilation. TOF ratio will be measured at the adductor pollicis using TOF-Watch SX neuromuscular monitoring.","From admission to the post-anesthesia care unit (PACU) through PACU discharge",{"measure":22,"description":23,"timeFrame":12},"Association Between Time Since the Last Rocuronium Dose and Postoperative Residual Neuromuscular Block, Measured as an Odds Ratio","The association between the time interval from the last rocuronium administration to postoperative TOF measurement and PRNB will be assessed using an odds ratio (OR). The time interval will be recorded in minutes. PRNB is defined as a normalized TOF ratio \\\u003C0.90 measured at the adductor pollicis using TOF-Watch SX neuromuscular monitoring.",null,{"allocation":24,"interventionModel":24,"interventionModelDescription":24,"primaryPurpose":24,"observationalModel":26,"timePerspective":27,"maskingInfo":24},"COHORT","PROSPECTIVE","This is a prospective, single-center observational cohort study involving children aged 2-12 years undergoing elective dental procedures under general anesthesia in whom rocuronium is administered for neuromuscular blockade. The study is designed to determine the incidence of postoperative residual neuromuscular block (PRNB) after clinical extubation and to investigate whether passive smoke exposure is associated with an increased risk of PRNB.\n\nAnesthetic management will be performed according to the study protocol. Following clinical recovery and extubation, patients will be transferred to the post-anesthesia care unit (PACU), where quantitative neuromuscular function will be assessed using a TOF-Watch SX monitor. Ulnar nerve stimulation and the adductor pollicis response will be used for train-of-four (TOF) monitoring. PRNB will be defined as a TOF ratio \\\u003C0.9.\n\nPassive smoke exposure will be assessed using information obtained from the parent or legal guardian, including the presence and number of smokers in the household, smoking by the primary caregiver, smoking inside the home, daily cigarette consumption, and the duration of the child's exposure. Participants will be classified according to the presence or absence of passive smoke exposure.\n\nIn addition to determining the incidence of PRNB, the study will evaluate the association between passive smoke exposure and PRNB, the relationship between TOF ratio and postoperative respiratory complications, and the effect of the interval between the last dose of rocuronium and TOF assessment on PRNB.","The study population will consist of children aged 2-12 years undergoing dental procedures under general anesthesia with rocuronium administration. Participants will be categorized according to the presence or absence of passive smoke exposure as reported by a parent or legal guardian. Postoperative neuromuscular function will be assessed using quantitative train-of-four monitoring after extubation.",[31,36],{"label":32,"type":24,"description":33,"interventionNames":34},"Passive Smoke Exposure","Children with passive smoke exposure as reported by the parent or legal guardian",[35],"Other: Passive Smoke Exposure",{"label":37,"type":24,"description":38,"interventionNames":24},"No Passive Smoke Exposure","Children without passive smoke exposure as reported by the parent or legal guardian",[40],{"type":6,"name":32,"description":41,"armGroupLabels":42,"otherNames":24},"Passive smoke exposure is defined based on parental or legal guardian report of the child's exposure to tobacco smoke in the household or other environments. No intervention is administered as part of the study",[32],[44],{"name":45,"role":46,"phone":47,"phoneExt":24,"email":48},"Metin ilteray Kıkılı, MD","CONTACT","+905439782131","metin.kikili@iuc.edu.tr",[50],{"facility":51,"status":24,"city":52,"state":52,"zip":53,"country":54,"countryCode":24,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Istanbul University-Cerrahpasa, Institute of Cardiology","Istanbul","34093","Turkey (Türkiye)",{"type":56,"coordinates":57},"Point",[58,59],28.94966,41.01384,{"lat":59,"lon":58},[62,63,65],{"name":45,"role":46,"phone":47,"phoneExt":24,"email":48},{"name":24,"role":46,"phone":24,"phoneExt":24,"email":64},"drkikili@gmail.com",{"name":45,"role":66,"phone":24,"phoneExt":24,"email":24},"PRINCIPAL_INVESTIGATOR",{"type":66,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Metin İlteray Kıkılı","Anesthesiologist","100656865","postoperative-residual-neuromuscular-block-and-passive-smoke-exposure-in-pediatric-dental-patients-100656865",false,"NCT07831434","Postoperative Residual Neuromuscular Block and Passive Smoke Exposure in Pediatric Dental Patients","Association Between Postoperative Residual Neuromuscular Block After Rocuronium Administration and Passive Smoke Exposure in Pediatric Patients Undergoing Dental Procedures","Inclusion Criteria:\n\n* Children aged 2-12 years\n* Scheduled to undergo dental procedures under general anesthesia\n* Administration of rocuronium as part of routine anesthetic management\n* Written informed consent obtained from a parent or legal guardian\n\nExclusion Criteria:\n\n* Known neuromuscular disease\n* Known allergy or contraindication to rocuronium\n* Use of medications known to significantly affect neuromuscular transmission\n* Severe hepatic or renal dysfunction\n* Inability to obtain reliable postoperative TOF measurements","ALL","2 Years","12 Years",{"count":81,"type":82},55,"ESTIMATED","OBSERVATIONAL","Postoperative residual neuromuscular block (PRNB) may persist despite apparent clinical recovery from neuromuscular blockade and may increase the risk of postoperative respiratory complications. Quantitative neuromuscular monitoring is therefore important for identifying incomplete neuromuscular recovery. This prospective, single-center observational cohort study aims to determine the incidence of PRNB in pediatric patients undergoing dental procedures under general anesthesia with rocuronium and to evaluate the association between passive smoke exposure and PRNB. Children aged 2-12 years will undergo quantitative neuromuscular assessment using the TOF-Watch SX after clinical extubation and admission to the post-anesthesia care unit (PACU). PRNB will be defined as a train-of-four (TOF) ratio \\\u003C0.9. The incidence of PRNB will be determined, and its association with passive smoke exposure and perioperative clinical variables will be evaluated.",[86,87],"Postoperative Residual Curarization","Neuromuscular Block Prolonged",[89,32,90,91,92,93],"Postoperative Residual Neuromuscular Block","Train-of-Four Monitoring","Rocuronium","Pediatric Anesthesia","Neuromuscular Monitoring","NOT_YET_RECRUITING","2026-09-15",{"date":97,"type":98},"2026-09-21","ACTUAL",{"date":100,"type":82},"2026-09",{"date":102,"type":82},"2027-09",{"name":5,"class":6},1]