[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585667":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":43,"responsibleParty":63,"collaborators":25,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":25,"enrollmentInfo":75,"targetDuration":25,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":88,"overallStatus":46,"whyStopped":25,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Universitätsklinikum Hamburg-Eppendorf","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"NOL (Nociception Level Index)","EXPERIMENTAL","Opioid administration (sufentanil) guided by the Nociception Level Index (NOL) derived from photoplethysmography, galvanic skin conductance, and the measurement of skin temperature performed by the device PMD-200 Nociception Monitor from the manufacturer Medasense Biometrics Ltd, Ramat Yishai, Israel. Included in the monitoring system is software that continuously calculates the NOL from normalized heart rate variability, pulse plethysmographic amplitude, skin conductance, and skin temperature derived from a finger sensor. The numerical index ranges from 0 (low sympathetic tone) to 100 (high sympathetic tone). A NOL score between 10 and 25 has been proposed as the target range based on which to guide opioid analgesics dosage. 5 µg sufentanil will be administered if the NOL score exceeds 25 for more than 60 seconds. The sufentanil boluses may be repeated to keep NOL between 10-25 accordingly.",[13],"Procedure: NOL (Nociception Level Index)",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","ACTIVE_COMPARATOR","Opioid administration (sufentanil) based on standard clinical practice where attending anesthesiologists are advised to administer 5 µg sufentanil if signs of inadequate anesthesia are present. Given adequate hypnosis (BIS 40-60), these signs include hypertension (MAP\\>120% of baseline or \\>100mmHg), tachycardia (HR\\>120% of baseline or \\>90\u002Fmin), somatic arousal (coughing, chewing, grimacing) and somatic response (purposeful movement). The patient-specific baseline is defined as the average of three consecutive post-induction, pre-surgery MAP and HF values. The time elapsed between 5µg doses of sufentanil is up to the anesthesiologist's discretion.",[19],"Other: Control (Standard treatment)",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Elective surgery in patients having trauma and orthopedic surgery with a combination of general and regional anesthesia. Opioid titration is guided by NOL during general anesthesia in the experimental arm.",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Control (Standard treatment)","Opioid administration (sufentanil) guided according to standard clinical practice of the attending anesthesiologist",[15],[31],{"name":32,"affiliation":5,"role":33},"Rainer Nitzschke, MD","PRINCIPAL_INVESTIGATOR",[35,39],{"name":32,"role":36,"phone":37,"phoneExt":25,"email":38},"CONTACT","+4915222815884","r.nitzschke@uke.de",{"name":40,"role":36,"phone":41,"phoneExt":25,"email":42},"Annika Zoller","+49040741052415","ana-sek@uke.de",[44],{"facility":45,"status":46,"city":47,"state":25,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Department of Anesthesiology; Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg Eppendorf","RECRUITING","Hamburg","20246","Germany","DE",{"type":52,"coordinates":53},"Point",[54,55],9.99302,53.55073,{"lat":55,"lon":54},[58,59],{"name":32,"role":36,"phone":37,"phoneExt":25,"email":38},{"name":60,"role":36,"phone":61,"phoneExt":25,"email":62},"Kim C Koschmieder, MD","+4915222832365","k.koschmieder@uke.de",{"type":64,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100585667","guiding-opioid-administration-by-nociception-level-index-nol-in-patients-with-regional-anesthesia-100585667",false,"NCT06905340","Guiding Opioid Administration by Nociception Level Index (NOL) in Patients With Regional Anesthesia","Nociception Level Index-Guided Intraoperative Opioids in Patients With a Combination of General and Regional Anesthesia","NORA","Inclusion Criteria:\n\n\\- Patients undergoing elective trauma or orthopedic surgery with a combination of general and regional anesthesia\n\nExclusion Criteria:\n\n* Preexisting therapy with cardiac glycosides or pacemakers\n* Cardiac arrhythmia (atrial fibrillation, atrioventricular block \\> I°)\n* Chronic opioid misuse\n* Intraoperative treatment with ketamine, beta-adrenergic agonists, or clonidine\n* Serious peripheral or cardiac autonomic neuropathy\n* Inability to specify the postoperative pain level\n* Postoperative treatment in an ICU","ALL","18 Years",{"count":76,"type":77},240,"ESTIMATED","INTERVENTIONAL",[80],"NA","General anesthesia consists of a combination of hypnotic drugs to achieve unconsciousness and opioid analgesics to ensure antinociception. An alternative approach to the intraoperative administration of high-potency opioids to achieve antinociception during surgery is combining general anesthesia with regional anesthesia. Modern general anesthesia aims to avoid an overdose of opioid analgesics and reduce side effects of opioid administration. Quality and safety of general anesthesia are of major clinical importance and can be improved by adjusting the opioid analgesics to the optimal individual dose needed.\n\nIn current clinical practice, opioid dosage is usually determined by clinical judgment. However, different monitoring devices estimating the effect of nociception during unconsciousness have become commercially available. One of the most recent commercially available nociception indices is the Nociception Level Index (NOL). Until today, there is conflicting evidence on whether guiding sufentanil administration by NOL monitoring, which is the intended use of the nociception index, affects postoperative pain level in the postanesthesia care unit (PACU), the amount of postoperatively administered opioids, and the quality of postoperative recovery in patients with a combination of general and regional anesthesia. This study aims to investigate the clinical performance of intraoperative NOL monitoring and determine whether guiding sufentanil administration by NOL monitoring - compared to routine care - reduces either postoperative pain level in the PACU, postoperative opioid consumption in the PACU or postoperative opioid consumption in the first 24 hours after the operation in patients having trauma and orthopedic surgery with combined general and regional anesthesia.",[83,84,85,86,87],"Nociceptive Pain","Pain, Postoperative","Analgesia, Postoperative","Anesthesia Recovery Period","Opioid Use",[89,90,91,92],"General anesthesia","Regional anesthesia","Analgesia Monitoring","Opioids","2025-06-04",{"date":95,"type":96},"2025-06-08","ACTUAL",{"date":98,"type":96},"2025-05-12",{"date":100,"type":77},"2026-01",{"name":5,"class":6},1]