[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100538478":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":49,"responsibleParty":68,"collaborators":42,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":72,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":42,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":92,"overallStatus":52,"whyStopped":42,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"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,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Maisonneuve-Rosemont Hospital - CIUSSS de l'Est de l'Île de Montréal","RECRUITING","Montreal East","Quebec","H1T2M4","Canada","CA",{"type":59,"coordinates":60},"Point",[61,62],-73.5075,45.63202,{"lat":62,"lon":61},[65,67],{"name":66,"role":40,"phone":41,"phoneExt":42,"email":43},"Pascal Laferrière-Langois, MD FRQS",{"name":66,"role":37,"phone":42,"phoneExt":42,"email":42},{"type":37,"investigatorFullName":36,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"MD, MSc, FRQS, Assistant Professor, Principal Investigator, Anesthesiologist","100538478","phase-4-impact-of-administration-of-esmolol-on-nociception-level-guided-control-of-nociception-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":82,"type":83},64,"ESTIMATED","INTERVENTIONAL",[86],"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.",[89,90,91],"Opioid Use, Unspecified","Anesthesia","Nociceptive Pain",[93,94,95,96],"opioid sparing anesthesia","beta blockers","nociception monitoring","general anesthesia","2024-07-15",{"date":99,"type":100},"2024-07-16","ACTUAL",{"date":102,"type":100},"2024-04-16",{"date":104,"type":83},"2025-03-04",{"name":5,"class":6},1]