[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637077":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":27,"locations":27,"responsibleParty":37,"collaborators":27,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":43,"sex":49,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":27,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":67,"whyStopped":27,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":27},{"fullName":5,"class":6},"TC Erciyes University","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Pre-emptive Local Anesthesia Group","EXPERIMENTAL","Children randomized to this group will receive pre-emptive local anesthesia before the dental procedure under standardized low-flow sevoflurane-based general anesthesia.",[13,14,15],"Procedure: Pre-emptive Local Anesthesia","Drug: Articaine With Epinephrine","Drug: Sevoflurane",{"label":17,"type":18,"description":19,"interventionNames":20},"No Pre-emptive Local Anesthesia Group","ACTIVE_COMPARATOR","Children randomized to this group will not receive routine pre-emptive local anesthesia before the dental procedure. Rescue local anesthesia, if clinically required, will be recorded separately.",[15],[22,28,33],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"PROCEDURE","Pre-emptive Local Anesthesia","Pre-emptive local anesthesia will be administered before the dental procedure according to the planned dental treatment. The application sites, total volume, total dose, and dose per kilogram will be recorded.",[9],null,{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":27},"DRUG","Articaine With Epinephrine","Articaine with epinephrine will be used for local anesthesia before the dental procedure in the pre-emptive local anesthesia group. The total administered volume, total dose, dose per kilogram, and injection sites will be recorded.",[9],{"type":29,"name":34,"description":35,"armGroupLabels":36,"otherNames":27},"Sevoflurane","Sevoflurane will be used for maintenance of general anesthesia in both study groups. Sevoflurane administration will be titrated to maintain bispectral index values within the target range of 40 to 60 under standardized low-flow anesthesia.",[17,9],{"type":38,"investigatorFullName":39,"investigatorTitle":40,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"PRINCIPAL_INVESTIGATOR","seher orbay yasli","Associate Professor","100637077","pre-emptive-local-anesthesia-and-sevoflurane-consumption-in-pediatric-dental-anesthesia-100637077",false,"NCT07608900","Pre-emptive Local Anesthesia and Sevoflurane Consumption in Pediatric Dental Anesthesia","Effect of Pre-emptive Local Anesthesia on Sevoflurane Consumption, Agent Uptake, and Carbon Footprint in Pediatric Day-case Dental General Anesthesia: A Prospective Randomized Controlled Trial","PEDSEVOLA","Inclusion Criteria:\n\n* Children aged 4 to 12 years\n* Scheduled for elective day-case dental treatment under general anesthesia\n* ASA physical status I or II\n* Planned sevoflurane-based general anesthesia\n* Planned oral endotracheal intubation\n* Eligibility for standardized low-flow anesthesia with fresh gas flow of 1 L\u002Fmin\n* Eligibility for BIS-guided sevoflurane titration\n* Written informed consent obtained from a parent or legal guardian\n\nExclusion Criteria:\n\n* Age younger than 4 years or older than 12 years\n* ASA physical status III or higher\n* Emergency dental procedures\n* Known allergy or contraindication to sevoflurane\n* Known allergy or contraindication to amide local anesthetics, articaine, or epinephrine\n* Known or suspected malignant hyperthermia susceptibility\n* Significant cardiovascular, respiratory, hepatic, renal, or neurological disease requiring non-standard anesthetic management\n* Chronic opioid or sedative use\n* Planned airway management other than oral endotracheal intubation\n* Dental procedures in which withholding pre-emptive local anesthesia is considered clinically inappropriate for safety or hemostasis\n* Refusal of participation by parent or legal guardian","ALL","4 Years","12 Years",{"count":53,"type":54},80,"ESTIMATED","INTERVENTIONAL",[57],"NA","This study will evaluate whether pre-emptive local anesthesia reduces sevoflurane consumption during pediatric day-case dental treatment performed under general anesthesia.\n\nChildren aged 4 to 12 years scheduled for elective dental treatment under general anesthesia will be included. Participants will be assigned to either receive pre-emptive local anesthesia before the dental procedure or receive no pre-emptive local anesthesia. General anesthesia will be standardized using sevoflurane, low fresh gas flow, endotracheal intubation, and bispectral index monitoring.\n\nThe main outcome will be sevoflurane consumption expressed as mL\u002Fkg\u002Fhour. Secondary outcomes will include anesthetic agent uptake, time from sevoflurane discontinuation to extubation, and estimated carbon dioxide-equivalent emissions.\n\nThe aim is to determine whether pre-emptive local anesthesia can reduce volatile anesthetic requirement and improve early recovery while maintaining adequate anesthetic depth in children undergoing dental general anesthesia.",[60],"Sevoflurane Consumption",[62,34,63,64,65,66],"Pediatric dental anesthesia","Sevoflurane consumption","Pre-emptive local anesthesia","Agent uptake","Carbon footprint","NOT_YET_RECRUITING","2026-05-20",{"date":70,"type":71},"2026-05-27","ACTUAL",{"date":73,"type":54},"2026-08",{"date":75,"type":54},"2027-09",{"name":5,"class":6}]