[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599472":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":24,"centralContacts":28,"locations":36,"responsibleParty":53,"collaborators":10,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":70,"studyType":71,"phases":10,"briefSummary":72,"conditions":73,"keywords":78,"overallStatus":39,"whyStopped":10,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Radboud University Medical Center","OTHER",[8],{"label":9,"type":10,"description":10,"interventionNames":11},"Patients aged 1 to 12 years undergoing surgery with general anesthesia.",null,[12,13],"Device: Connecting all patients to the nociception level index(NOL) and the surgical pleth index (SPI)","Device: All patient will receive a tetanic stimuli (60mA, 100hz) of 5 seconds before start of incision",[15,20],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","Connecting all patients to the nociception level index(NOL) and the surgical pleth index (SPI)","All patients will be connected to the NOL and SPI during surgery after induction of general anesthesia.",[9],{"type":16,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"All patient will receive a tetanic stimuli (60mA, 100hz) of 5 seconds before start of incision","All patient will receive a tetanic stimuli (60mA, 100hz) of 5 seconds before start of incision.",[9],[25],{"name":26,"affiliation":5,"role":27},"Ignacio Malagon, Professor","PRINCIPAL_INVESTIGATOR",[29,34],{"name":30,"role":31,"phone":32,"phoneExt":10,"email":33},"Cees klein Tank, Drs.","CONTACT","+31 (024) 365 57 55","cees.kleintank@radboudumc.nl",{"name":26,"role":31,"phone":32,"phoneExt":10,"email":35},"ignacio.malagon@radboudumc.nl",[37],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Radboud university medical centre","RECRUITING","Nijmegen","Gelderland","6525 GA","Netherlands","NL",{"type":46,"coordinates":47},"Point",[48,49],5.85278,51.8425,{"lat":49,"lon":48},[52],{"name":30,"role":31,"phone":32,"phoneExt":10,"email":33},{"type":27,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Ignacio Malagon","prof. Jose Ignacio Malagon Calle MD, PhD","100599472","comparison-of-the-surgical-pleth-index-and-the-nociception-level-index-in-the-pediatric-population-100599472",false,"NCT07084935","Comparison of the Surgical Pleth Index and the Nociception Level Index in the Pediatric Population","Comparison of the Surgical Pleth Index and the Nociception Level Index in the Pediatric Population: An Observational Study","NOLvsSPI","Inclusion Criteria:\n\n* Male or female\n* ASA I, ASA II and ASA III\n* Aged 1 to 12 years old\n* Scheduled to undergo elective surgery with general anaesthesia\n\nExclusion Criteria:\n\n* Patients with chronic pain\n* Patients with chronic analgesia usage.\n* Known allergy to the adhesives used in the sensors.\n* No free available limb to attach the probes to.","ALL","1 Year","12 Years",{"count":68,"type":69},40,"ESTIMATED","1 Day","OBSERVATIONAL","This observational study aims to compare two nociception monitoring methods. The Nociception Level (NOL) index and the Surgical Pleth Index (SPI) in the pediatric population during general anesthesia. While both monitors are designed to assess nociceptive responses through autonomic nervous system activity, they differ in methodology and parameters measured. The NOL index integrates multiple physiological signals using a self-learning algorithm, while SPI focuses on heart rate variability and plethysmographic amplitude. Although both have been studied individually in children, a direct comparison has not yet been conducted. This study will evaluate and compare each monitor's ability to detect and quantify nociceptive stimuli (surgical and tetanic) in children.\n\nThe investigators hypothesize that the NOL monitor and SPI monitor will both be able to quantify surgical stimuli and tetanic stimuli with monitors response to surgical stimuli \\> monitors response to tetanic stimuli. However, the investigators also hypothesize that the NOL index will do this superiorly, as it utilizes a self-learning algorithm and more parameters are incorporated in its algorithm",[74,75,76,77],"Nociceptive Pain","Anesthesia","Pediatric Anesthesia","Nociception Monitoring",[79,80,81,82],"Nociception monitoring","Pediatric population","NOL index","Surgical pleth index","2025-07-24",{"date":85,"type":86},"2025-07-25","ACTUAL",{"date":88,"type":86},"2025-07-04",{"date":90,"type":69},"2026-07-31",{"name":5,"class":6},1]