[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100538478":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":49,"responsibleParty":67,"collaborators":42,"id":69,"slug":42,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":42,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":90,"overallStatus":52,"whyStopped":42,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Ciusss de L'Est de l'Île de Montréal","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Esmolol","EXPERIMENTAL","In the Esmolol group, intravenous esmolol will be given as a bolus (0.5mg.kg-1) over 5 minutes, and will be started simultaneously to the remifentanil initiation.\n\nOnce the bolus of esmolol is over, a perfusion of 20 mcg.kg-1.min-1 will be programmed and maintained until the end of the surgery and completion of skin sutures",[13],"Drug: Esmolol Hydrochloride",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of care","PLACEBO_COMPARATOR","In the standard of care group, intravenous saline bolus, equivalent to an esmolol bolus (0.5mg.kg-1) will be given over 5 minutes, and will be started simultaneously to the remifentanil initiation.\n\nOnce the bolus of saline is over, a saline perfusion equivalent to an esmolol infusion of 20 mcg.kg-1.min-1 will be programmed and maintained until the end of the surgery and completion of skin sutures",[19],"Drug: Saline",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Esmolol Hydrochloride","Patients in the experimental group will receive esmolol during general anesthesia",[9],[27],"Brevibloc",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Saline","Patients in the standard of care group will receive saline as placebo during general anesthesia",[15],[33],"saline serum",[35],{"name":36,"affiliation":5,"role":37},"Pascal Laferrière-Langlois","PRINCIPAL_INVESTIGATOR",[39,44],{"name":36,"role":40,"phone":41,"phoneExt":42,"email":43},"CONTACT","+1-819-432-5847",null,"pascal.laferriere-langlois@umontreal.ca",{"name":45,"role":40,"phone":46,"phoneExt":47,"email":48},"Nadia Godin","514-252-3400","3193","ngodin.hmr@ssss.gouv.qc.ca",[50],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Maisonneuve-Rosemont Hospital - CIUSSS de l'Est de l'Île de Montréal","RECRUITING","Montreal East","Quebec","H1T2M4","Canada",{"type":58,"coordinates":59},"Point",[60,61],-73.5075,45.63202,{"lat":61,"lon":60},[64,66],{"name":65,"role":40,"phone":41,"phoneExt":42,"email":43},"Pascal Laferrière-Langois, MD FRQS",{"name":65,"role":37,"phone":42,"phoneExt":42,"email":42},{"type":37,"investigatorFullName":36,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"MD, MSc, FRQS, Assistant Professor, Principal Investigator, Anesthesiologist","100538478",false,"NCT06291363","Impact of Administration of Esmolol on Nociception Level-guided Control of Nociception.","Impact of Continuous Intraoperative Administration of Esmolol on Nociception Level-guided Control of Nociception. The EsmoNOL Randomized Controlled Trial","ESMONOL","Inclusion Criteria:\n\n* Fully consented, American Society of Anesthesiologists Classification Score 1-3 patients from 18yo to 65yo\n* Undergoing laparoscopic surgery associated with sub umbilical mini-laparotomy. Eligible surgeries will be hysterectomy (excluding vaginal approach) and left hemicolectomy, of duration time expected under 180 minutes, under general anesthesia\n* No allergy to one of the medications used in this study\n\nExclusion Criteria:\n\nContraindication to the use of the study drug (esmolol) is an exclusion criterion :\n\n* Hypotension\n* Sinus bradycardia\n* Sick sinus syndrome\n* Second and third degree A-V block\n* Pulmonary hypertension\n* Right ventricular failure secondary to pulmonary hypertension\n* Decompensated heart failure\n* Cardiogenic shock\n* Nontreated pheochromocytoma\n* Known hypersensitivity to esmolol or any of the inactive ingredients of the product\n* Allergy to esmolol or other beta blockers (cross-sensitivity is possible)\n* Renal dysfunction\n* Airway disease such as asthma or chronic obstructive pulmonary disease\n* Thyrotoxicosis\n* Myasthenia gravis\n* Raynaud's disease or peripheral circulatory disorder\n\nOther situations leading to exclusion :\n\n* Severe mental impairment\n* Chronic use of opioids, β-adrenergic receptors antagonists\n* High risk of conversion to laparotomy according to the surgical team (\\>25%)\n\nPatients will automatically be excluded after recruitment if they withdraw their consent, or if laparoscopy is converted to laparotomy.","ALL","18 Years","65 Years",{"count":80,"type":81},64,"ESTIMATED","INTERVENTIONAL",[84],"PHASE4","This study aims to evaluate esmolol's perfusion impact during induction and maintenance of general anesthesia, using Nociception-Level-guided control of nociception, in adult patients undergoing laparoscopic and lower abdominal surgery, on intraoperative remifentanil consumption and postoperative pain in the Post-Anesthesia Care Unit.",[87,88,89],"Opioid Use, Unspecified","Anesthesia","Nociceptive Pain",[91,92,93,94],"opioid sparing anesthesia","beta blockers","nociception monitoring","general anesthesia","2024-07-15",{"date":97,"type":98},"2024-07-16","ACTUAL",{"date":100,"type":98},"2024-04-16",{"date":102,"type":81},"2025-03-04",{"name":5,"class":6},1]