[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100490149":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":43,"responsibleParty":62,"collaborators":26,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":26,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":26,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":46,"whyStopped":26,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"University of Southern Denmark","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard Clinical Care Group","PLACEBO_COMPARATOR","Hemodynamic changes outside of the normal range i.e., hypertension (systolic blood pressure greater than 140 mm Hg), tachycardia (heart rate greater than 90 min-1) and hypotension (mean arterial pressure less than 60 mm Hg) will be first assessed using the guidance of Bispectral index and Train of four monitors. Sufentanil in doses of 2.5 to 5 mcg (maximum of 0.6-1.2 mic\u002Fkg for the entire surgery) is administered if the Bispectral index and Train of four monitor values are within normal range and if required vasopressor infusion is used. Vasoconstrictors may be given as a continuous infusion of norepinephrine, or bolus doses of ephedrine or phenylephrine. Only when blood pressure remains, low additional crystalloids will be given. Finally, in case of bradycardia (heart rate less than 30 min-1), atropine may be given",[13],"Device: Standard care",{"label":15,"type":16,"description":17,"interventionNames":18},"Nociception Level-guided Analgesia Group","EXPERIMENTAL","In the nociception level-guided group, sufentanil will be administered to maintain a nociception level value between 10 and 25. In case the nociception level values rise greater than 25 for more than 60 s, additional 2.5 microgram sufentanil (if nociception level increase remained less than 45) or 5 micrograms (if nociception level increase greater than 45). Atropine will be administered when heart rate decreases less than 30 min-1. Because the nociception level may be sensitive to such medication, nociception level values will then not used for at least 5 min to guide analgesia, with the exception of norepinephrine as this drug will be given as continuous infusion",[19],"Device: Nociception Level monitor (NOL)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Nociception Level monitor (NOL)","NOL technology uses a multiparameter-based sensor platform, and advanced algorithm, to continuously monitor Autonomic Nervous System (ANS) functions. NOL reflects a patient's nociceptive state and analgesic effect, helping to optimize the administration of systemic and\u002For regional analgesics, and avoiding overdose or underuse of these drugs. The nociception level is a multiparameter monitor that combines information from the finger photoplethysmogram amplitude, skin conductance, skin conductance fluctuation, heart rate, heart rate variability, and their time derivatives into one index ranging from 0 (absence of noxious stimulation) to 100 (severe noxious stimulation).",[15],null,{"type":22,"name":28,"description":11,"armGroupLabels":29,"otherNames":26},"Standard care",[9],[31],{"name":32,"affiliation":33,"role":34},"Thomas Strøm","Hospital of Southern Denmark - Aabenraa","STUDY_DIRECTOR",[36,40],{"name":32,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","+45 79 97 00 00","thomas.strom@rsyd.dk",{"name":41,"role":37,"phone":38,"phoneExt":26,"email":42},"Rajesh Bhavsar","Rajesh.prabhakar.Bhavsar@rsyd.dk",[44],{"facility":45,"status":46,"city":47,"state":26,"zip":26,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Anaesthesiology and Intensive Care Research Unit","RECRUITING","Aabenraa","Denmark","DK",{"type":51,"coordinates":52},"Point",[53,54],9.41741,55.04434,{"lat":54,"lon":53},[57,59],{"name":32,"role":37,"phone":26,"phoneExt":26,"email":58},"thomas.stroem@rsyd.dk",{"name":60,"role":37,"phone":26,"phoneExt":26,"email":61},"Rajesh Prabhakar Bhavsar","mailto:Rajesh.Prabhakar.Bhavsar@rsyd.dk",{"type":63,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100490149","influence-of-nociception-level-monitor-nol-guided-analgesic-delivery-on-robot-assisted-colorectal-surgery-100490149",false,"NCT05662371","Influence of Nociception Level Monitor (NOL) Guided Analgesic Delivery on Robot-assisted Colorectal Surgery","Influence of Nociception Level Monitor (NOL) Guided Analgesic Delivery on the Perioperative Course, Quality of Recovery and Hospital Stay in Robot-assisted Colorectal Surgery","Inclusion Criteria:\n\n* American Society of Anaesthesiologists score III-IV\n* Scheduled for elective major robot-assisted colorectal surgeries\n\nExclusion Criteria:\n\n* Inability to give informed consent\n* planned spinal or epidural anaesthesia\n* all forms of regional anaesthesia, including wound infiltration\n* nonelective procedures\n* pregnancy or lactation\n* atrial fibrillation","ALL","18 Years","80 Years",{"count":75,"type":76},60,"ESTIMATED","INTERVENTIONAL",[79],"NA","Being relatively new, the NOL monitor may offer interesting observations in perioperative nociception levels and appropriate analgesic consumption in diverse surgeries, including robot-assisted surgery. These observations may supplement the current efforts towards further advantages in rapid restitution. Therefore, the investigators planned a trial where intra-operative analgesics were guided using an NOL monitor to study if intra-operative NOL guidance influences peri-operative analgesic consumption, postoperative length of stay and quality of recovery of patients subjected for robot-assisted surgery.",[82,83],"Opioid Use, Unspecified","Pain, Postoperative",[85,86,87,88],"Nociception,","robotic surgery,","opioids,","postoperative recovery","2026-05-11",{"date":91,"type":92},"2026-05-14","ACTUAL",{"date":94,"type":92},"2023-08-01",{"date":96,"type":76},"2027-03-31",{"name":5,"class":6},1]