[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654514":3},{"organization":4,"outcomesModule":7,"designInfo":42,"detailedDescription":53,"studyPopulation":41,"armGroups":54,"interventions":65,"overallOfficials":41,"centralContacts":73,"locations":83,"responsibleParty":97,"collaborators":41,"id":101,"slug":102,"hasResults":103,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":41,"eligibilityCriteria":107,"healthyVolunteers":103,"sex":108,"minAge":109,"maxAge":110,"enrollmentInfo":111,"targetDuration":41,"studyType":114,"phases":115,"briefSummary":117,"conditions":118,"keywords":124,"overallStatus":129,"whyStopped":41,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},{"fullName":5,"class":6},"Konya City Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":41},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of emergence delirium assessed by the Pediatric Anesthesia Emergence Delirium (PAED) scale","Emergence delirium is assessed in the post-anesthesia care unit using the Pediatric Anesthesia Emergence Delirium (PAED) scale by an assessor masked to group allocation. The scale comprises five items, each scored from 0 to 4, giving a total score from 0 to 20, where higher scores indicate more severe emergence delirium. A participant is classified as having emergence delirium if the peak PAED score is 10 or greater at any assessment. The outcome is reported as the proportion of participants in each arm meeting this threshold.","From arrival in the post-anesthesia care unit until discharge criteria are met (modified Aldrete score greater than 9) plus 30 minutes of further observation, assessed up to 2 hours after discontinuation of sevoflurane",[14,18,22,26,30,34,38],{"measure":15,"description":16,"timeFrame":17},"Time to laryngeal mask airway removal","Interval from discontinuation of sevoflurane to removal of the laryngeal mask airway. The airway is removed when the child exhibits a regular respiratory pattern and purposeful movement of the extremities without physical stimulation. Recorded in minutes by a masked assessor.","From discontinuation of sevoflurane to laryngeal mask airway removal, assessed up to 30 minutes",{"measure":19,"description":20,"timeFrame":21},"Time to eye opening","Interval from discontinuation of sevoflurane to eye opening in response to a verbal stimulus. Recorded in minutes by a masked assessor.","From discontinuation of sevoflurane to eye opening, assessed up to 30 minutes",{"measure":23,"description":24,"timeFrame":25},"Time to post-anesthesia care unit discharge readiness","Interval from arrival in the post-anesthesia care unit to the point at which discharge criteria are met, defined as a modified Aldrete post-anesthesia score greater than 9. The modified Aldrete score assesses activity, respiration, circulation, consciousness and oxygen saturation, each scored 0 to 2, for a total of 0 to 10, with higher scores indicating more complete recovery. Recorded in minutes by a masked assessor.","From arrival in the post-anesthesia care unit until a modified Aldrete score greater than 9 is achieved, assessed up to 2 hours",{"measure":27,"description":28,"timeFrame":29},"Incidence of intraoperative hypotension","Proportion of participants experiencing at least one episode of intraoperative hypotension, defined as a fall in mean arterial pressure of more than 20 percent below the pre-induction baseline value, sustained for at least one minute. Non-invasive blood pressure is measured at intervals of no more than 5 minutes throughout surgery.","From induction of anesthesia to the end of surgery, assessed up to 4 hours",{"measure":31,"description":32,"timeFrame":33},"Duration of surgery Description: Interval from surgical","nterval from surgical incision to completion of the surgical procedure, recorded in minutes.","From surgical incision to completion of surgery, assessed up to 4 hours",{"measure":35,"description":36,"timeFrame":37},"Intraoperative heart rate","Heart rate in beats per minute recorded at baseline before induction, after induction, after laryngeal mask airway placement, at surgical incision, at 15-minute intervals during surgery, and at the end of surgery. Reported as mean and standard deviation per arm at each time point.","From before induction to the end of surgery, assessed up to 4 hours",{"measure":39,"description":40,"timeFrame":37},"Intraoperative mean arterial pressure","mean arterial pressure in mmHg, recorded at baseline",null,{"allocation":43,"interventionModel":44,"interventionModelDescription":45,"primaryPurpose":46,"observationalModel":41,"timePerspective":41,"maskingInfo":47},"RANDOMIZED","PARALLEL","Parallel-group design. Participants are randomly assigned 1:1 to one of two arms and remain in that arm throughout; there is no crossover. Both arms receive an identical background anesthetic: midazolam premedication, propofol induction, laryngeal mask airway placement 90 seconds after the study opioid bolus, sevoflurane maintenance at 1 MAC, and preemptive intravenous paracetamol and ketamine. The arms differ only in the maintenance opioid and its mode of delivery: fentanyl as an intravenous bolus followed by intermittent doses every 30 minutes until the end of surgery, or remifentanil as an intravenous bolus followed by a continuous infusion. Because these modes of administration differ, the attending anesthesiologist cannot be masked; emergence delirium is scored in the post-anesthesia care unit by an assessor unaware of allocation. Each participant is assessed once, postoperatively.","TREATMENT",{"masking":48,"maskingDescription":49,"whoMasked":50},"DOUBLE","Participants and outcome assessors are masked. Participants are unconscious when the study opioid is given, having received propofol induction, and neither they nor their parents are told the assigned arm until all postoperative assessments are complete. Outcome assessment is performed by an investigator or recovery unit nurse who is not present in the operating room, takes no part in delivering anesthesia, and is unaware of allocation; this assessor performs all PAED scale scoring and records time to eye opening, time to laryngeal mask airway removal, and the modified Aldrete score. The anesthesia record remains with the operating room team. The attending anesthesiologist cannot be masked, as the arms require different modes of administration. The statistician is masked, with arms coded A and B until analysis is complete.",[51,52],"PARTICIPANT","OUTCOMES_ASSESSOR","Background and Rationale\n\nEmergence delirium, also termed emergence agitation, is a postoperative complication of pediatric anesthesia characterized by disturbances of perception and psychomotor behavior. It presents as a dissociative state of consciousness in which the child is restless, crying, non-cooperative, incoherent, inconsolable, or thrashing in bed. Reported incidence ranges from 25% to 80%, is higher in children under six years of age, and is observed most frequently after anesthesia with the volatile agents sevoflurane and desflurane.\n\nEmergence delirium is not a self-limited nuisance. Affected children are at increased risk of inadvertent removal of intravenous cannulae, self-injury, and postoperative nausea and vomiting. The condition adversely affects recovery and well-being, prolongs hospital length of stay, increases health care costs, and may be followed by maladaptive behavioral change persisting for weeks after anesthesia.\n\nShort-acting opioids, including fentanyl and remifentanil, are used in children both as sedatives and analgesics and to blunt the hemodynamic response to surgical stimulation and airway instrumentation; they have also been evaluated as preventive agents for emergence agitation. Remifentanil is attractive because of its rapid onset, absence of accumulation, and short context-sensitive half-time. However, published trials of remifentanil and emergence agitation under sevoflurane anesthesia are inconsistent: infusion-based regimens have been reported both to reduce and to increase the incidence of agitation. This trial is designed to resolve that inconsistency in a defined pediatric surgical population by directly comparing fentanyl with remifentanil maintenance, and to examine the relationship between intraoperative remifentanil use and the quality of postoperative recovery.\n\nObjectives and Hypotheses\n\nThe primary objective is to compare the effect of intraoperative remifentanil versus fentanyl maintenance on the occurrence of postoperative emergence delirium. The primary hypothesis is that remifentanil produces less delirium than fentanyl in pediatric urologic surgery. The secondary objective is to examine the effect of remifentanil on the postoperative recovery process, with the hypothesis that its effect is dose-dependent and that higher infusion rates may deepen intraoperative hypotension.\n\nStudy Design and Conduct\n\nThis is a single-center, parallel-group, randomized controlled trial conducted with institutional review board approval, written informed consent from a parent or legal guardian, and assent from the child. Consent includes permission for data sharing with the research coordination center at the University of Health Sciences, Konya City Hospital. Participants are allocated in a 1:1 ratio to Group F (fentanyl) or Group R (remifentanil).\n\nAnesthetic Protocol\n\nAll children receive intravenous midazolam 0.05 mg\u002Fkg five minutes before entering the operating room and are monitored with electrocardiography, pulse oximetry, non-invasive blood pressure measurement, and capnography. Anesthesia is induced with propofol 3-5 mg\u002Fkg. After loss of consciousness, Group F receives fentanyl 1 μg\u002Fkg as a bolus followed by 1 μg\u002Fkg intravenously every 30 minutes until the end of surgery, and Group R receives remifentanil 0.5 μg\u002Fkg followed by a continuous infusion of 1 μg\u002Fkg\u002Fmin. In both groups a laryngeal mask airway is inserted 90 seconds after the bolus dose, and anesthesia is maintained with sevoflurane titrated to 1 MAC together with the assigned opioid. Immediately after induction, all patients receive preemptive intravenous paracetamol and ketamine 0.3 mg\u002Fkg.\n\nAt the end of surgery, sevoflurane and the assigned opioid are discontinued. The laryngeal mask airway is removed once the child shows a regular respiratory pattern and purposeful movement of the extremities without physical stimulation. Children are then observed in the post-anesthesia care unit, where emergence behavior, recovery milestones, and hemodynamic data are recorded, and are transferred to the ward after a further 30 minutes of observation once post-anesthesia discharge criteria are met.\n\nStatistical Considerations\n\nThe sample size was projected from a previously published observational study of emergence and postoperative delirium. Assuming an emergence delirium prevalence of approximately 15.75%, 90% power, a two-sided alpha of 0.05, and an allowance of 4.91% for protocol deviations and adverse events, 88 participants per group (176 in total) were required.\n\nNormality of distribution is assessed with the Shapiro-Wilk test. Demographic data and scale scores are summarized descriptively as mean ± standard deviation or as counts and percentages. Between-group comparisons of continuous variables are made with the independent-samples t test, and relationships between variables are examined by correlation analysis with reporting of confidence intervals. A two-sided P value \\\u003C 0.05 is considered statistically significant.",[55,61],{"label":56,"type":57,"description":58,"interventionNames":59},"Group R: Remifentanil","ACTIVE_COMPARATOR","Participants receive remifentanil 0.5 microgram\u002Fkg intravenously after loss of consciousness, followed by a continuous maintenance infusion of 1 microgram\u002Fkg\u002Fminute until the end of surgery. Background anesthesia is identical in both arms: midazolam 0.05 mg\u002Fkg premedication, propofol 3-5 mg\u002Fkg induction, laryngeal mask airway placed 90 seconds after the bolus, sevoflurane titrated to 1 MAC, and preemptive intravenous paracetamol and ketamine 0.3 mg\u002Fkg after induction.",[60],"Drug: Opioids",{"label":62,"type":57,"description":63,"interventionNames":64},"Group F: Fentanyl","Participants receive fentanyl 1 microgram\u002Fkg intravenously after loss of consciousness, followed by a maintenance dose of 1 microgram\u002Fkg intravenously every 30 minutes until the end of surgery. Background anesthesia is identical in both arms: midazolam 0.05 mg\u002Fkg premedication, propofol 3-5 mg\u002Fkg induction, laryngeal mask airway placed 90 seconds after the bolus, sevoflurane titrated to 1 MAC, and preemptive intravenous paracetamol and ketamine 0.3 mg\u002Fkg after induction.",[60],[66],{"type":67,"name":68,"description":69,"armGroupLabels":70,"otherNames":71},"DRUG","Opioids","Remifentanil 0.5 microgram\u002Fkg intravenously after loss of consciousness, followed by a continuous maintenance infusion of 1 microgram\u002Fkg\u002Fminute until the end of surgery. And; Fentanyl 1 microgram\u002Fkg intravenously after loss of consciousness, followed by 1 microgram\u002Fkg intravenously every 30 minutes until the end of surgery.",[62,56],[72],"Fentanil and Ultiva",[74,79],{"name":75,"role":76,"phone":77,"phoneExt":41,"email":78},"Yasin Tire","CONTACT","05055367970","dryasintire@hotmail.com",{"name":80,"role":76,"phone":81,"phoneExt":41,"email":82},"Aydın Mermer","05067928318","aydinmer@yahoo.com",[84],{"facility":75,"status":41,"city":85,"state":86,"zip":87,"country":88,"countryCode":41,"cosmosGeoPoint":89,"geoPoint":94,"contacts":95},"Konya","Meram","42140","Turkey (Türkiye)",{"type":90,"coordinates":91},"Point",[92,93],32.48464,37.87135,{"lat":93,"lon":92},[96],{"name":75,"role":76,"phone":77,"phoneExt":41,"email":78},{"type":98,"investigatorFullName":99,"investigatorTitle":100,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"PRINCIPAL_INVESTIGATOR","Yasin Tire, MD","Assoc. Prof. Dr. Yasin Tire","100654514","phase-4-remifentanil-vs-fentanyl-in-children-7-12-after-urologic-surgery-emergence-delirium-and-recovery-quality-100654514",false,"NCT07800845","Remifentanil vs Fentanyl in Children 7-12 After Urologic Surgery: Emergence Delirium and Recovery Quality","The Effect of Remifentanil on Postoperative Emergence Delirium in Pediatric Urology Patients","Inclusion Criteria:\n\n* Age 7 to 12 years\n* American Society of Anesthesiologists (ASA) physical status I or II\n* Scheduled for elective pediatric urologic surgery\n* Surgery planned under general anesthesia with a laryngeal mask airway\n* Written informed consent from a parent or legal guardian, with assent from the child\n\nExclusion Criteria:\n\n* History of difficult airway or known airway abnormality\n* Reactive airway disease\n* Respiratory tract infection within the preceding 3 weeks\n* Abnormal cognitive development or developmental delay\n* Known allergy to any medication used in the study protocol\n* Chronic use of opioids, sedatives, or psychoactive medication","ALL","7 Years","12 Years",{"count":112,"type":113},88,"ESTIMATED","INTERVENTIONAL",[116],"PHASE4","Emergence delirium (agitation) is a common complication in children recovering from general anesthesia, especially after sevoflurane. Affected children wake in a dissociative state - restless, crying, inconsolable, unaware of their surroundings - with a reported incidence of 25-80%. It raises the risk of self-injury, accidental catheter removal, vomiting, and maladaptive behavior persisting for weeks, and prolongs hospital stay.\n\nShort-acting opioids such as fentanyl and remifentanil are widely used in pediatric anesthesia for sedation and analgesia and to blunt the hemodynamic response to surgical stimulation and airway instrumentation. Both have been proposed to reduce emergence agitation after sevoflurane anesthesia, but findings for remifentanil are inconsistent: some studies report a reduction, others an increase. Clinicians therefore lack clear guidance on opioid selection for maintenance.\n\nThis trial compares intraoperative remifentanil with intraoperative fentanyl maintenance on the occurrence of emergence delirium in children undergoing urologic surgery under general anesthesia. Secondary aims are postoperative recovery, duration of surgery, and intraoperative hemodynamics.\n\nDesign: single-center randomized controlled trial. 176 children aged 7-12 years, ASA I-II, scheduled for elective pediatric urologic surgery, randomized 1:1 (88 per group).\n\nAll participants receive the same background technique: intravenous midazolam 0.05 mg\u002Fkg five minutes before entering the operating room; standard monitoring (ECG, pulse oximetry, non-invasive blood pressure, capnography); induction with propofol 3-5 mg\u002Fkg; laryngeal mask airway (LMA); sevoflurane titrated to 1 MAC; and preemptive intravenous paracetamol and ketamine 0.3 mg\u002Fkg after induction.\n\nThe fentanyl group receives fentanyl 1 mcg\u002Fkg after loss of consciousness, then 1 mcg\u002Fkg every 30 minutes until the end of surgery. The remifentanil group receives remifentanil 0.5 mcg\u002Fkg, then an infusion of 1 mcg\u002Fkg\u002Fmin. In both groups the LMA is inserted 90 seconds after the bolus.\n\nAt the end of surgery sevoflurane is discontinued and the LMA removed once the child breathes regularly and moves purposefully without stimulation. Emergence delirium is assessed in the post-anesthesia care unit with the Pediatric Anesthesia Emergence Delirium (PAED) scale (0-20). Additional measurements include time from sevoflurane discontinuation to LMA removal, time to eye opening on verbal stimulus, and readiness for discharge.",[119,120,121,122,123],"Emergence Delirium","Emergence Agitation","Anesthesia Recovery Period","Postoperative Complications","Urologic Surgical Procedures",[125,126,127,128],"Emergence delirium","Emergence agitation","PAED scale","Pediatric patients.","NOT_YET_RECRUITING","2026-10-03",{"date":132,"type":133},"2026-10-06","ACTUAL",{"date":135,"type":113},"2026-09-05",{"date":137,"type":113},"2027-01-25",{"name":5,"class":6},1]