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Respiratory and Haemodynamic Effects of Conscious Sedation With Dexmedetomidine for a TAVI Procedure

RecruitingNAAges 60 Years - anyAllErasme University Hospital
NCT07532733 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. The 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. The 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

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📋 Eligibility rules (as published)
Inclusion Criteria: * -aged 60 or over, * undergoing transfemoral TAVI, * treated under sedation without general anaesthesia, * having given their written informed consent, * with sufficient command of French to undertake cognitive tests. Exclusion Criteria: * whose first language is not English, * who have a contraindication to dexmedetomidine, * who require conversion to general anaesthesia during the procedure, * or who present with major haemodynamic instability (shock, uncontrolled arrhythmia).
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What it tests

  • Sedation with dexmedetomidine
  • sedation propofol and remifentanil
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Where

1 site
HUB Erasme
Brussels, Belgium
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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