protocolSection identificationModule nctId: NCT06291363, orgStudyIdInfo id: 2024-3612, briefTitle: Impact of Administration of Esmolol on Nociception Level-guided Control of Nociception., acronym: ESMONOL, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-04, primaryCompletionDateStruct date: 2025-03-03, completionDateStruct date: 2025-03-04, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Ciusss de L'Est de l'Île de Montréal, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Opioid Use, Unspecified, conditions: Anesthesia, conditions: Nociceptive Pain, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Two groups of patients randomized into Group "ESMOLOL" for esmolol and group "Standard of Care" for a total of 64 participants., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Randomization will be done prior to the entrance in the OR, the day of the surgery., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 64, type: ESTIMATED, armsInterventionsModule interventions name: Esmolol Hydrochloride, interventions name: Saline, outcomesModule primaryOutcomes measure: Intra operative remifentanil administration, secondaryOutcomes measure: The NOL Index variation before and after orotracheal intubation and first surgical incision, secondaryOutcomes measure: The mean intraoperative blood pressure and heart rate, secondaryOutcomes measure: doses and time weighted of norepinephrine (mg); ephedrine (mg), glycopyrrolate (mg) and atropine (mg), secondaryOutcomes measure: Total time with NOL value above > 25, secondaryOutcomes measure: The total time and time weighted average of hypotension and/or bradycardia, secondaryOutcomes measure: The time to first analgesic requirement in PACU, secondaryOutcomes measure: The amount of morphine equivalent consumption, secondaryOutcomes measure: The intensity of pain at rest and under stress, secondaryOutcomes measure: Postoperative nausea and vomiting (PONV) and antiemetics use, secondaryOutcomes measure: The time spent in PACU, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Maisonneuve-Rosemont Hospital - CIUSSS de l'Est de l'Île de Montréal, city: Montréal-Est, state: Quebec, zip: H1T2M4, country: Canada, contacts name: Pascal Laferrière-Langois, MD FRQS, role: CONTACT, phone: +1-819-432-5847, email: pascal.laferriere-langlois@umontreal.ca, contacts name: Pascal Laferrière-Langois, MD FRQS, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.63202, lon: -73.5075, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2024-02-26, uploadDate: 2024-03-21T17:38, filename: Prot_000.pdf, size: 732855, hasResults: False