HUB Erasme
Brussels, 1070, Belgium
Location status: Recruiting
NCT Number: NCT07532733
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 '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.
Physiologically, 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.
Several 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.
However, data specific to the context of TAVI under conscious sedation remain limited, particularly regarding the prospective and standardised assessment of intraoperative respiratory events.
This 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.
Interested in participating?
Request Info60 year and older
All sexes
Interventional
Not applicable
Brussels, 1070, Belgium
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Loading dose (optional depending on tolerance): 0.5 µg/kg administered as a slow infusion over 10 minutes (no direct bolus to avoid bradycardia).
Maintenance infusion: 0.2 to 0.7 µg/kg/h. Start at 0.4 µg/kg/h. Adjust in increments of 0.1-0.2 µg/kg/h depending on the level of sedation observed.
Target: RASS -2 to 0 (patient calm, arable to verbal stimulation).
Adjustment of sedation:
If agitation/discomfort:
If significant drowsiness/bradycardia:
If hypotension (SBP < 90 mmHg):
→ Reduce flow rate and administer crystalloids ± vasopressor (noradrenaline)
Propofol and remifentanil will be administered via target-controlled infusion (TCI) pumps in accordance with standard pharmacokinetic models:
Sedation will be titrated to maintain a RASS score between -2 and 0 (patient calm, arousable to verbal stimulation).
Start the infusion at the lower target (propofol 0.5 µg/mL; remifentanil 1.0 ng/mL). Gradually adjust every 2-3 minutes based on RASS, signs of discomfort or pain, and haemodynamic and respiratory stability.
If agitation/discomfort:
Increase Propofol by 0.2 µg/ml and Remifentanil by 0.3 ng/ml
If hypoventilation (EtCO₂ > 50 or FR < 8) :
Reduce Propofol by 0.2 µg/ml or Remifentanil by 0.3 ng/ml.
If bradycardia < 45 bpm: Pacing
If hypotension (SBP < 90 mmHg):
Reduce the infusion rate and administer crystalloids ± a vasopressor (noradrenaline)
Maximum remifentanil dose: 2.5 ng/mL Maximum propofol dose: 1.5 µg/mL
Time frame: during sedation for TAVI procedure
Oxygen desaturation, defined as:
Bradypnoea, defined as a respiratory rate < 10 breaths per minute,
Impaired ventilation as evidenced by capnography, measured using the CapnoLine® device, including:
Respiratory monitoring will be carried out continuously throughout the procedure, including monitoring of oxygen saturation, respiratory rate and capnography
Time frame: the day before TAVI procedure and between 24 and 48 hours postoperatively.
Changes in the MoCA (Montreal Cognitive Assessment) score between the preoperative period (performed the day before de TAVI procedure) and the postoperative period (performed between 24 and 48 hours after TAVI procedure).
The MoCA is a rapid cognitive screening test, scored out of 30, used to identify mild or more severe cognitive impairment. A score of 30/30 indicates the absence of cognitive impairment. The lower the score, the more severe the cognitive impairment. Here, we will examine the difference between the pre- and post-measurements, which will be calculated statistically using the score.
Time frame: during sedation and TAVI procedure
Variations blood pressure during the procedure. Blood pressure will be measured in mm Hg using an arterial catheter.
Need for vasopressors or corrective interventions.
Time frame: during sedation and TAVI procedure
Variations in haert rate (beat per minute) during the procedure. Need for corrective interventions.
Time frame: Day 0 (at the completion of the TAVI procedure)
Assessment of patient comfort, of the anaesthetist and the operating cardiologist using Visual Analog Scale (ranging from 0 to 10).
A score of 0 indicates complete dissatisfaction, whilst a score of 10 indicates maximum satisfaction
Time frame: up to 30 days
Hospital length of stay (in days) defined as the time from completion of the TAVI procedure until hospital discharge
Time frame: up to 30 days
Occurrence of intra- and post-operative adverse events related to sedation, from the start of the sedation for TAVI procedure until the hospital discharge
Contact information is provided by the study sponsor or research team.
Erasme University Hospital
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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