[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633903":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":34,"locations":40,"responsibleParty":57,"collaborators":11,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":11,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":11,"enrollmentInfo":69,"targetDuration":11,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":43,"whyStopped":11,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Erasme University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"sedation dexmedetomidine","EXPERIMENTAL",null,[13],"Drug: Sedation with dexmedetomidine",{"label":15,"type":16,"description":11,"interventionNames":17},"sedation propofol-remifentanil","ACTIVE_COMPARATOR",[18],"Drug: sedation propofol and remifentanil",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","Sedation with dexmedetomidine","Loading dose (optional depending on tolerance): 0.5 µg\u002Fkg administered as a slow infusion over 10 minutes (no direct bolus to avoid bradycardia).\n\nMaintenance infusion: 0.2 to 0.7 µg\u002Fkg\u002Fh. Start at 0.4 µg\u002Fkg\u002Fh. Adjust in increments of 0.1-0.2 µg\u002Fkg\u002Fh depending on the level of sedation observed.\n\nTarget: RASS -2 to 0 (patient calm, arable to verbal stimulation).\n\nAdjustment of sedation:\n\nIf agitation\u002Fdiscomfort:\n\n* Increase Dexdor by 0.1 µg\u002Fkg\u002Fh.\n* If persistent: sufentanil bolus 2.5-5 µg.\n\nIf significant drowsiness\u002Fbradycardia:\n\n* Reduce by 0.1 µg\u002Fkg\u002Fh.\n* If bradycardia \\\u003C 45 bpm: Pacemaker in place by surgical team\n\nIf hypotension (SBP \\\u003C 90 mmHg):\n\n→ Reduce flow rate and administer crystalloids ± vasopressor (noradrenaline)",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"sedation propofol and remifentanil","Propofol and remifentanil will be administered via target-controlled infusion (TCI) pumps in accordance with standard pharmacokinetic models:\n\nSedation will be titrated to maintain a RASS score between -2 and 0 (patient calm, arousable to verbal stimulation).\n\nStart the infusion at the lower target (propofol 0.5 µg\u002FmL; remifentanil 1.0 ng\u002FmL). Gradually adjust every 2-3 minutes based on RASS, signs of discomfort or pain, and haemodynamic and respiratory stability.\n\nIf agitation\u002Fdiscomfort:\n\nIncrease Propofol by 0.2 µg\u002Fml and Remifentanil by 0.3 ng\u002Fml\n\nIf hypoventilation (EtCO₂ \\> 50 or FR \\\u003C 8) :\n\nReduce Propofol by 0.2 µg\u002Fml or Remifentanil by 0.3 ng\u002Fml.\n\nIf bradycardia \\\u003C 45 bpm: Pacing\n\nIf hypotension (SBP \\\u003C 90 mmHg):\n\nReduce the infusion rate and administer crystalloids ± a vasopressor (noradrenaline)\n\nMaximum remifentanil dose: 2.5 ng\u002FmL Maximum propofol dose: 1.5 µg\u002FmL",[15],[30],{"name":31,"affiliation":32,"role":33},"celine Boudart","HUB - Erasme","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":11,"email":39},"Celine Boudart, MD PhD","CONTACT","+3225553919","celine.boudart@hubruxelles.be",[41],{"facility":42,"status":43,"city":44,"state":11,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"HUB Erasme","RECRUITING","Brussels","1070","Belgium","BE",{"type":49,"coordinates":50},"Point",[51,52],4.34878,50.85045,{"lat":52,"lon":51},[55],{"name":56,"role":37,"phone":38,"phoneExt":11,"email":39},"Celine Boudart",{"type":33,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Céline Boudart","MD PhD","100633903","respiratory-and-haemodynamic-effects-of-conscious-sedation-with-dexmedetomidine-for-a-tavi-procedure-100633903",false,"NCT07532733","Respiratory and Haemodynamic Effects of Conscious Sedation With Dexmedetomidine for a TAVI Procedure","Respiratory and Haemodynamic Effects Comparison of Conscious Sedation With Dexmedetomidine Versus Sedation With Remifentanil-propofol for a TAVI Procedure: a Prospective, Randomised, Single-blind Study","Inclusion Criteria:\n\n* -aged 60 or over,\n* undergoing transfemoral TAVI,\n* treated under sedation without general anaesthesia,\n* having given their written informed consent,\n* with sufficient command of French to undertake cognitive tests.\n\nExclusion Criteria:\n\n* whose first language is not English,\n* who have a contraindication to dexmedetomidine,\n* who require conversion to general anaesthesia during the procedure,\n* or who present with major haemodynamic instability (shock, uncontrolled arrhythmia).","ALL","60 Years",{"count":70,"type":71},80,"ESTIMATED","INTERVENTIONAL",[74],"NA","Transcatheter aortic valve implantation (TAVI) is now the standard procedure for elderly patients with severe aortic stenosis. This patient group is characterised by increased frailty, multiple comorbidities and limited physiological reserve, exposing them to an increased risk of intraoperative complications.\n\nThe majority of TAVI procedures are now performed under conscious sedation, in order to limit the risks associated with general anaesthesia and to promote a faster recovery. However, this strategy carries a risk of intraoperative respiratory events, notably bradypnoea, oxygen desaturation and airway obstruction, particularly in elderly patients with comorbidities.\n\nThe anaesthetic strategy, and in particular the type of sedation used, is likely to influence intraoperative respiratory and haemodynamic tolerance. Traditionally used agents, such as propofol combined with opioids, can induce dose-dependent respiratory depression. Conversely, dexmedetomidine, an α2-adrenergic receptor agonist, has a distinct pharmacological profile, characterised by sedation with a theoretically limited respiratory impact.\n\nHowever, comparative data regarding the impact of different sedation strategies on intraoperative respiratory tolerance during TAVI remain limited, justifying the conduct of this study.\n\nDexmedetomidine is a selective α2-adrenergic receptor agonist, used in anaesthesia and intensive care for its sedative and anxiolytic properties. It induces what is known as 'cooperative' sedation, characterised by the maintenance of relative alertness, the possibility of interacting with the patient and, above all, a limited impact on spontaneous breathing.\n\nPhysiologically, dexmedetomidine differs from conventional sedatives, such as propofol and opioids, in causing less respiratory depression, making it a particularly attractive option for conscious sedation. This property is essential in elderly and comorbid patients, particularly during procedures such as TAVI, where maintaining spontaneous ventilation is a major concern.\n\nSeveral clinical studies, particularly in procedural sedation and interventional cardiology, suggest that the use of dexmedetomidine is associated with better respiratory tolerance, with a reduction in episodes of desaturation, bradypnoea and the need for airway interventions, compared with strategies based on propofol and opioids.\n\nHowever, data specific to the context of TAVI under conscious sedation remain limited, particularly regarding the prospective and standardised assessment of intraoperative respiratory events.\n\nThis study therefore aims to address this knowledge gap by assessing the effect of dexmedetomidine, compared with standard sedation using propofol-remifentanil, on intraoperative respiratory tolerance in patients undergoing TAVI under conscious sedation.",[77],"TAVI(Transcatheter Aortic Valve Implantation)",[79,80,81],"TAVI","sedation","dexmedetomidine","2026-04-27",{"date":84,"type":85},"2026-04-30","ACTUAL",{"date":87,"type":85},"2026-04-22",{"date":89,"type":71},"2027-06-30",{"name":5,"class":6},1]