[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100448640":3},{"organization":4,"outcomesModule":7,"designInfo":57,"detailedDescription":56,"studyPopulation":56,"armGroups":67,"interventions":79,"overallOfficials":56,"centralContacts":89,"locations":98,"responsibleParty":112,"collaborators":56,"id":115,"slug":56,"hasResults":116,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":56,"eligibilityCriteria":120,"healthyVolunteers":116,"sex":121,"minAge":122,"maxAge":56,"enrollmentInfo":123,"targetDuration":56,"studyType":126,"phases":127,"briefSummary":129,"conditions":130,"keywords":132,"overallStatus":101,"whyStopped":56,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":143},{"fullName":5,"class":6},"Gangnam Severance Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":56},[9],{"measure":10,"description":11,"timeFrame":12},"Time to first gas passing from surgery","Time (hours) to first gas passing from surgery","Up to postoperative 2weeks",[14,18,22,26,30,33,37,40,42,45,49,52],{"measure":15,"description":16,"timeFrame":17},"Time to starting fluid intake from surgery","Time (hours) to starting oral fluid intake after surgery","up to 2weeks",{"measure":19,"description":20,"timeFrame":21},"Time to starting soft diet from surgery","Time (hours) to starting soft diet from surgery","up to 2 weeks",{"measure":23,"description":24,"timeFrame":25},"Intraoperative opioid consumption","Total opioid dose administered to the patient during anesthesia","during anesthesia",{"measure":27,"description":28,"timeFrame":29},"Postoperative opioid consumption","Total opioid dose administered to the patient after surgery.","postoperative 6hours, 12hours, 24hours, 36hours, 48hours, 3days, 4days, 5days.(Minimum value: 0, Maximum value: 10, higher score means worse.)",{"measure":31,"description":32,"timeFrame":29},"Pain score","Visual analog scale (VAS) 0-10",{"measure":34,"description":35,"timeFrame":36},"Nausea score","verbal numerical rating scale 0-10","postoperative 6hours, 12hours, 24hours, 36hours, 48hours, 3days, 4days, 5days",{"measure":38,"description":39,"timeFrame":17},"Time to first rescue analgesics from surgery","Time (hours) to first rescue analgesics from surgery.",{"measure":41,"description":41,"timeFrame":17},"Number of vomiting, antiemetic administration",{"measure":43,"description":44,"timeFrame":21},"Time to starting ambulation from surgery.","Time (hours) to starting ambulation from surgery",{"measure":46,"description":47,"timeFrame":48},"QoR-15","Score of QoR-15 questionnaire (Quality of Recovery-15) (Minimum value: 0, Maximum value: 150, higher score means better.)","postoperative 1days, 4days",{"measure":50,"description":51,"timeFrame":25},"Hemodynamics during anesthesia","hemodynamics (blood pressure, heart rate) during anesthesia",{"measure":53,"description":54,"timeFrame":55},"Plasma concentration of Cortisol, Norepinephrine, Epinephrine, IL-6","Plasma concentration of Cortisol(mcg\u002FdL), Norepinephrine(pg\u002FmL), Epinephrine(pg\u002FmL), IL-6(pg\u002FmL) immediately after surgery","immediately after surgery",null,{"allocation":58,"interventionModel":59,"interventionModelDescription":60,"primaryPurpose":61,"observationalModel":56,"timePerspective":56,"maskingInfo":62},"RANDOMIZED","PARALLEL","Single blinded randomized controlled study","PREVENTION",{"masking":63,"maskingDescription":64,"whoMasked":65},"SINGLE","Patients don't know which group they belong to.",[66],"PARTICIPANT",[68,75],{"label":69,"type":70,"description":71,"interventionNames":72},"ANI group","EXPERIMENTAL","Investigator will attach the ANI monitor V2 (MDoloris Medical Systems, Lille, France) to the patient and monitor Analgesia Nociception Index (ANI) during anesthesia. Remifentanil infusion rate is adjusted according to ANI monitoring. The ANI is adjusted to be between 50 and 70.",[73,74],"Device: ANI","Other: Control",{"label":76,"type":77,"description":78,"interventionNames":56},"Control group","NO_INTERVENTION","Remifentanil infusion rate is adjusted according to the conventional method of blood pressure and heart rate monitroing. Blood pressure and heart rate are controlled to be within 20% of baseline. We will not monitor ANI in this group.",[80,85],{"type":81,"name":82,"description":83,"armGroupLabels":84,"otherNames":56},"DEVICE","ANI","Investigators will attach the ANI monitor V2 (MDoloris Medical Systems, Lille, France) to the patient and monitor Analgesia Nociception Index (ANI) during anesthesia. Remifentanil infusion rate is adjusted according to ANI monitoring. The ANI is adjusted to be between 50 and 70.",[69],{"type":6,"name":86,"description":87,"armGroupLabels":88,"otherNames":56},"Control","Remifentanil infusion rate is adjusted according to the conventional method of blood pressure and heart rate monitroing. Blood pressure and heart rate are controlled to be within 20% of baseline. Investigators will not monitor ANI in this group.",[69],[90,95],{"name":91,"role":92,"phone":93,"phoneExt":56,"email":94},"Young Song","CONTACT","82-2-2019-3520","NEARMYHEART@yuhs.ac",{"name":96,"role":92,"phone":93,"phoneExt":56,"email":97},"Myung IL Bae","BMI87@yuhs.ac",[99],{"facility":100,"status":101,"city":102,"state":56,"zip":56,"country":103,"countryCode":56,"cosmosGeoPoint":104,"geoPoint":109,"contacts":110},"GangnamSeverance Hospital","RECRUITING","Seoul","South Korea",{"type":105,"coordinates":106},"Point",[107,108],126.9784,37.566,{"lat":108,"lon":107},[111],{"name":96,"role":92,"phone":93,"phoneExt":56,"email":97},{"type":113,"investigatorFullName":91,"investigatorTitle":114,"investigatorAffiliation":5,"oldNameTitle":56,"oldOrganization":56},"PRINCIPAL_INVESTIGATOR","Associate Professor","100448640",false,"NCT05122078","Effects of Analgesia Nociception Index (ANI)-Guided Analgesia on Postoperative Bowel Function.","Effects of Analgesia Nociception Index (ANI)-Guided Analgesia on Postoperative Bowel Function Recovery in Laparoscopic Colorectal Surgery: A Prospective Randomized-controlled Study","Inclusion Criteria:\n\n* Patients over 19 years who undergo laparoscopic colorectal surgery for colorectal cancer at Gangnam Severance Hospital, Seoul, South Korea.\n\nExclusion Criteria:\n\n* Emergency surgery\n* Patients with history of open abdominal surgery\n* Patients with arrhythmia\n* Patients with pacemaker insertion\n* Patients with history of heart transplantation\n* Patients taking medications that may affect ANI (antimuscarinics, alpha-agonists, beta blockers)\n* Patients with chronic opioid medication.\n* Cognitive impairment\n* Unable to read consent form (eg illiterate, foreigner, etc.)","ALL","19 Years",{"count":124,"type":125},80,"ESTIMATED","INTERVENTIONAL",[128],"NA","Investigators will examaine the effects of Analgesia Nociception Index (ANI)-guided analgesia on postoperative bowel function recovery in laparoscopic colorectal surgery. This is a prospective randomized-controlled study.\n\nInvestigators will randomly divide the patients into two groups. In ANI group, remifentanil infusion rate during anesthesia will be adjusted according to ANI monitoring. In Control group, remifentanil infusion rate during anesthesia will be adjusted according to the conventional method of blood pressure and heart rate monitroing. And Investigators will evalualte the bowel function recovery in both groups after surgery, and compare between the two groups.",[131],"Postoperative Bowel Function Recovery",[133],"Analgesia Nociception Index (ANI)","2024-09-02",{"date":136,"type":137},"2024-09-05","ACTUAL",{"date":139,"type":137},"2021-11-29",{"date":141,"type":125},"2025-10-14",{"name":5,"class":6},1]