TAVI(Transcatheter Aortic Valve Implantation)NCT07532733
Respiratory and Haemodynamic Effects of Conscious Sedation With Dexmedetomidine for a TAVI Procedure
A study testing Sedation with dexmedetomidine and sedation propofol and remifentanil in people with TAVI(Transcatheter Aortic Valve Implantation), run by Erasme University Hospital at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- TAVI(Transcatheter Aortic Valve Implantation)
- What is being tested?
- Sedation with dexmedetomidine and sedation propofol and remifentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBelgium
- Study dates
- 22 Apr 2026to 30 Jun 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
HUB Erasme
Brussels, 1070
Celine Boudart, +3225553919, celine.boudart@hubruxelles.be
About this study
Official title: 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
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.
Read more
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.
- Being tested
- Sedation with dexmedetomidine, sedation propofol and remifentanil
- Keywords
- TAVI, sedation, dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sedation with dexmedetomidineDrug
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:
- Increase Dexdor by 0.1 µg/kg/h.
- If persistent: sufentanil bolus 2.5-5 µg.
If significant drowsiness/bradycardia:
- Reduce by 0.1 µg/kg/h.
- If bradycardia < 45 bpm: Pacemaker in place by surgical team
If hypotension (SBP < 90 mmHg):
→ Reduce flow rate and administer crystalloids ± vasopressor (noradrenaline)
sedation propofol and remifentanilDrug
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
| Study group | Role | What they receive |
|---|---|---|
| sedation dexmedetomidine | Experimental | Not described Receives: Drug: Sedation with dexmedetomidine |
| sedation propofol-remifentanil | Active comparator | Not described Receives: Drug: sedation propofol and remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
the occurrence of an intraoperative respiratory event during a TAVI procedure performed under sedation
Oxygen desaturation, defined as:
- moderate desaturation with an SpO₂ ≤ 95%,
- severe/significant desaturation with an SpO₂ ≤ 90%,
Bradypnoea, defined as a respiratory rate < 10 breaths per minute,
Impaired ventilation as evidenced by capnography, measured using the CapnoLine® device, including:
- a reduction in waveform amplitude,
- respiratory irregularity,
- or any abnormality consistent with hypoventilation or airway obstruction.
Respiratory monitoring will be carried out continuously throughout the procedure, including monitoring of oxygen saturation, respiratory rate and capnography
Measured: during sedation for TAVI procedure
Secondary outcomes (6)
Postoperative cognitive function
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.
Measured: the day before TAVI procedure and between 24 and 48 hours postoperatively.
Intraoperative blood pressure stability
Variations blood pressure during the procedure. Blood pressure will be measured in mm Hg using an arterial catheter.
Need for vasopressors or corrective interventions.
Measured: during sedation and TAVI procedure
Heart Rate stability during procedure
Variations in haert rate (beat per minute) during the procedure. Need for corrective interventions.
Measured: during sedation and TAVI procedure
Comfort and quality of sedation
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
Measured: Day 0 (at the completion of the TAVI procedure)
Length of hospital stay
Hospital length of stay (in days) defined as the time from completion of the TAVI procedure until hospital discharge
Measured: up to 30 days
Tolerance and safety
Occurrence of intra- and post-operative adverse events related to sedation, from the start of the sedation for TAVI procedure until the hospital discharge
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start22 Apr 2026
- Primary completion30 May 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TAVI(Transcatheter Aortic Valve Implantation)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Céline Boudart, Erasme University Hospital
- Investigators
- celine Boudart, Principal investigator, HUB - Erasme
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07532733
- Sponsor's protocol ID
- HUB2025720
- Status last verified
- Apr 2026
- First submitted
- 2 Apr 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided