protocolSection identificationModule nctId: NCT06323616, orgStudyIdInfo id: 2023/2343, briefTitle: The Effect of Anesthesia Depth Monitoring on Emergence Delirium in Pediatrics, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-25, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2024-09-01, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Istanbul University, class: OTHER, descriptionModule briefSummary: Some changes in the patient's cognitive state are observed during the recovery period from general anesthesia. This period of behavioral dysregulation has been called emergence agitation (EA) and emergence delirium (ED). ED and EA occur in the early postoperative period (often within the first 30 minutes). The incidence of ED ranges from 10% to 80% in children and is described as a distressing clinical condition by 42% of pediatric anesthesiologists. Self-harm by the child increases the risk of delayed discharge and may increase the cost of medical care.Sevoflurane is a widely used agent for the induction and maintenance of anesthesia, but its use is associated with the occurrence of ED in the pediatric population. Clinical findings are characterized by hallucinations, struggling, restlessness, crying, and disorientation.In the literature, the Pediatric Anesthesia Rescue Delirium (PAED) Scale Score is used in the diagnosis of ED and EA. This score consists of 5 criteria (maximum score 20) scored using 0-4 point scales. These criteria; The child needs to make eye contact with the caregiver, the child's movements are purposeful, the child is aware of the environment, the child is restless/angry, the child cannot be consoled. While the sensitivity of ≥10 points for the diagnosis of ED is 64% and the specificity is 86%, the sensitivity of \>12 points for the diagnosis of ED is 100% and the specificity is 94.5%.Monitoring intraoperative depth of anesthesia in the adult population has been recommended by the American Society of Anesthesiologists (ASA) due to its potential benefits such as faster recovery time and lower drug dosage, as well as prevention of adverse effects such as the incidence of hypotension. The use of anesthesia depth monitors used so far for children is controversial because brain development in children has not yet been completed and the calculation algorithms of these indices are based on adult EEG characteristics.There are very few studies in the literature on the relationship between anesthesia depth monitoring and EA/ED in children, and further studies are needed., conditionsModule conditions: Anesthesia, conditions: Emergence Delirium, conditions: Anesthesia Awareness, conditions: Behavior Child Problems, conditions: Postoperative Delirium, conditions: Postoperative Complications, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized, Single-Blind, Prospective, Interventional, primaryPurpose: SCREENING, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 270, type: ESTIMATED, armsInterventionsModule interventions name: MAC adjustment to PSI between 25 and 50, outcomesModule primaryOutcomes measure: ED/EA incidence, secondaryOutcomes measure: mYPAS, secondaryOutcomes measure: PSI <25 episode duration, secondaryOutcomes measure: PSI >50 episode duration, secondaryOutcomes measure: PSI <25 number of episodes, secondaryOutcomes measure: PSI >50 number of episodes, secondaryOutcomes measure: Suppresyon ratio, secondaryOutcomes measure: SEF95R, secondaryOutcomes measure: SEF95L, secondaryOutcomes measure: Mean blood pressure, secondaryOutcomes measure: Heart rate, secondaryOutcomes measure: SpO2, secondaryOutcomes measure: Total amount of sevoflurane used, secondaryOutcomes measure: Total amount of remifentanil used, secondaryOutcomes measure: MAC, secondaryOutcomes measure: Waking up time, secondaryOutcomes measure: Pupil size, secondaryOutcomes measure: Anesthesia duration, secondaryOutcomes measure: Surgery duration, secondaryOutcomes measure: PHBQ, secondaryOutcomes measure: Ped-PADS, secondaryOutcomes measure: Time of discharge from hospital, eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 8 Years, stdAges: CHILD, contactsLocationsModule locations facility: Istanbul University, status: RECRUITING, city: Istanbul, country: Turkey, contacts name: Meltem Savran Karadeniz, Assoc. Prof., role: CONTACT, phone: 009005334845563, email: mskaradeniz@gmail.com, geoPoint lat: 41.01384, lon: 28.94966, locations facility: Istanbul University, status: RECRUITING, city: Istanbul, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False