[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639599":3},{"organization":4,"outcomesModule":7,"designInfo":28,"detailedDescription":31,"studyPopulation":32,"armGroups":11,"interventions":33,"overallOfficials":37,"centralContacts":41,"locations":51,"responsibleParty":67,"collaborators":11,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":11,"enrollmentInfo":79,"targetDuration":11,"studyType":82,"phases":11,"briefSummary":83,"conditions":84,"keywords":89,"overallStatus":53,"whyStopped":11,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Centre Hospitalier Princesse Grace","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Variation of the Analgesia Nociception Index (ANI) during the 5 minutes following rapid sequence intubation",null,"5 minutes post-induction",[14,16,18,21,23,25],{"measure":15,"description":11,"timeFrame":12},"Variation of hemodynamic parameters (heart rate, systolic and diastolic blood pressure) during the 5 minutes post-RSI",{"measure":17,"description":11,"timeFrame":12},"Occurrence of regurgitation during RSI",{"measure":19,"description":11,"timeFrame":20},"First-attempt intubation success rate","At time of intubation",{"measure":22,"description":11,"timeFrame":12},"Variation of SpO2 during the 5 minutes post-RSI",{"measure":24,"description":11,"timeFrame":12},"Identification of factors associated with reduced pain (lower ANI variation)",{"measure":26,"description":11,"timeFrame":27},"Presence of sore throat 24 hours after intubation","24 hours post-intubation",{"allocation":11,"interventionModel":11,"interventionModelDescription":11,"primaryPurpose":11,"observationalModel":29,"timePerspective":30,"maskingInfo":11},"COHORT","PROSPECTIVE","Background: RSI is a standard technique in anesthesia, primarily used to minimize the risk of aspiration. European guidelines leave the choice of hypnotic and neuromuscular blocking agent to the practitioner; the role of analgesics is not addressed. RSI induces sympathetic reactions linked to intense painful stimulation. Several monitors enable nociception assessment during general anesthesia, including in paralyzed patients (ANI, NOL, SPI). To date, no study has explored pain using the Analgesia Nociception Index during RSI.\n\nHypothesis: Rapid sequence induction induces sympathetic reactions associated with intense painful stimulation, which can be quantified using ANI.\n\nPrimary objective: To describe the impact on pain monitored by ANI of rapid sequence induction in anesthesia.\n\nSecondary objectives: (1) Describe early complications (desaturation, hypotension, regurgitation); (2) Explore factors associated with pain; (3) Explore factors associated with complications.\n\nMethods: Prospective monocentric observational cohort study, in routine care, with no additional examinations beyond standard management. Patients are monitored according to Société Française d'Anesthésie et de Réanimation (SFAR) guidelines, with additional non-invasive cutaneous electrodes placed on the right pectoral area for ANI monitoring. Induction begins after preoxygenation of at least 3 minutes. Induction drugs are at the discretion of the anesthesiologist. A timer is started at injection of the first induction drug (T0). Hemodynamic and ANI parameters are recorded during the first 5 minutes.\n\nData collected: date of intervention, age, sex, ASA score, Mallampati score, Cormack classification, preoperative analgesics (paracetamol within 4h, nefopam, tramadol, morphine, ketoprofen), induction drugs (hypnotic: propofol\u002Fetomidate\u002Fketamine; opioid: remifentanil\u002Falfentanil\u002Fsufentanil; neuromuscular blocker: succinylcholine\u002Frocuronium), heart rate and systolic\u002Fdiastolic blood pressure (T preO2, T1min, T3min, T5min), ANI and SpO2 (T preO2, minimum value \\\u003C5min), intubation device (McGrath \u002F Airtraq \u002F direct laryngoscopy), time between neuromuscular blocker injection and cuff inflation, presence of postoperative sore throat at 24h.\n\nStatistical analysis: descriptive analysis of patient characteristics; mixed models for evaluation of variables over the 5 minutes post-RSI; multivariate models to identify associated risk factors. Two-sided p-values \\\u003C0.05 will be considered statistically significant. Analyses performed with R software.\n\nFollow-up duration: 24 hours per patient. Total inclusion period: 24 months.","Patient requiring tracheal intubation after rapid sequence induction",[34],{"type":6,"name":35,"description":36,"armGroupLabels":11,"otherNames":11},"No Intervention: Observational Cohort","Standard rapid sequence induction according to SFAR guidelines, with additional non-invasive ANI monitoring via cutaneous pectoral electrodes. No intervention beyond routine care; induction drug choice (hypnotic, opioid, neuromuscular blocker) at the discretion of the anesthesiologist.",[38],{"name":39,"affiliation":5,"role":40},"Remy WIDEHEM, MD","PRINCIPAL_INVESTIGATOR",[42,47],{"name":43,"role":44,"phone":45,"phoneExt":11,"email":46},"Remy WIDEHEM","CONTACT","+377 97 98 99 00","remy.widehem@chpg.mc",{"name":48,"role":44,"phone":49,"phoneExt":11,"email":50},"Celine DUGOURD","+377 97 98 84 29","recherche.clinique@chpg.mc",[52],{"facility":5,"status":53,"city":54,"state":11,"zip":55,"country":54,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"RECRUITING","Monaco","98000","MC",{"type":58,"coordinates":59},"Point",[60,61],7.42145,43.73718,{"lat":61,"lon":60},[64],{"name":65,"role":44,"phone":66,"phoneExt":11,"email":46},"Rémy WIDEHEM, MD","0037797989900",{"type":68,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100639599","pain-assessment-during-rapid-sequence-induction-100639599",false,"NCT07588165","Pain Assessment During Rapid Sequence Induction","Nociception Assessment During Rapid Sequence Induction: A Prospective Observational Study of Practices and Complications - The NARSI Study","NARSI","Inclusion Criteria:\n\n* Age \\>= 18 years\n* Patient requiring tracheal intubation after rapid sequence induction in the visceral surgery operating room\n* Pain monitoring by Analgesia Nociception Index (ANI) as part of general anesthesia\n\nExclusion Criteria:\n\n* Patient with atrial fibrillation at the time of intubation following rapid sequence induction\n* Patient on long-term beta-blocker therapy","ALL","18 Years",{"count":80,"type":81},150,"ESTIMATED","OBSERVATIONAL","Rapid sequence induction (RSI) is a standard anesthesia technique used in patients at risk of aspiration. Although tracheal intubation following RSI is a frequent and painful procedure, no study has yet evaluated nociception using the Analgesia Nociception Index (ANI) during this procedure.\n\nThis monocentric prospective observational study aims to describe the impact of RSI on pain measured by ANI, and to explore early complications (desaturation, hypotension, regurgitation) and factors associated with pain and complications. 150 patients undergoing RSI in the visceral surgery operating room at CHPG Monaco will be analyzed.",[85,86,87,88],"Rapide Sequence Induction","Tracheal Intubation","Nociception","General Anesthesia",[90,91,92,93,94,95],"Analgesia Nociception Index (ANI)","Rapid Sequence Induction (RSI)","Pain monitoring","Tracheal intubation","Hemodynamic response","General anesthesia","2026-05-22",{"date":98,"type":99},"2026-05-27","ACTUAL",{"date":101,"type":99},"2026-05-21",{"date":103,"type":81},"2028-05",{"name":5,"class":6},1]