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

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Summary

NIH registered clinical trial NCT07532733 comparing dexmedetomidine versus propofol with remifentanil for conscious sedation during transcatheter aortic valve implantation (TAVI). The study aims to evaluate intraoperative respiratory and hemodynamic tolerance in elderly patients with severe aortic stenosis. Trial status dated April 16, 2026.

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What changed

NIH registered a clinical trial (NCT07532733) evaluating sedation strategies for TAVI procedures. The study compares dexmedetomidine (an α2-adrenergic receptor agonist) against propofol with remifentanil, focusing on respiratory and hemodynamic effects in elderly patients with severe aortic stenosis.

Affected parties include hospitals and cardiac centers performing TAVI procedures, as well as anesthesiologists and cardiologists involved in procedural sedation protocols. The trial addresses the knowledge gap regarding optimal sedation approaches that minimize respiratory complications in this high-frailty patient population.

Archived snapshot

Apr 16, 2026

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

N/A NCT07532733 Kind: NA Apr 16, 2026

Abstract

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 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.

However, comparative data regarding the impact of different sedation strategies on intraoperative respiratory tolerance during TAVI remain limited, justifying the conduct of this study.

Dexmedetomidine 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 'cooperati...

Conditions: TAVI(Transcatheter Aortic Valve Implantation)

Interventions: Sedation with dexmedetomidine, sedation propofol and remifentanil

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Last updated

Classification

Agency
NIH
Published
April 16th, 2026
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
NCT07532733
Docket
NCT07532733

Who this affects

Applies to
Healthcare providers
Industry sector
6211 Healthcare Providers
Activity scope
Clinical trial registration Conscious sedation research Cardiac procedure research
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Topics
Pharmaceuticals

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