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

NCT07532733 | Not Yet Recruiting

• 1 other identifier: HUB2025720
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

TAVI(Transcatheter Aortic Valve Implantation)

Keywords

TAVI; sedation; dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• 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

  during sedation for TAVI procedure

Secondary Outcomes (6)

• Postoperative cognitive function

  the day before TAVI procedure and between 24 and 48 hours postoperatively.

• Intraoperative blood pressure stability

  during sedation and TAVI procedure

• Heart Rate stability during procedure

  during sedation and TAVI procedure

• Comfort and quality of sedation

  Day 0 (at the completion of the TAVI procedure)

• Length of hospital stay

  up to 30 days

Study Arms (2)

sedation dexmedetomidine

EXPERIMENTAL

Drug: Sedation with dexmedetomidine

sedation propofol-remifentanil

ACTIVE COMPARATOR

Drug: sedation propofol and remifentanil

Interventions

Sedation with dexmedetomidine DRUG

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 dexmedetomidine

sedation propofol and remifentanil DRUG

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

sedation propofol-remifentanil

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Erasme University Hospital: lead

Study Sites (1)

HUB Erasme

Brussels, 1070, Belgium

Location

MeSH Terms

Interventions

Dexmedetomidine; Remifentanil

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines

Study Officials

• celine Boudart

  HUB - Erasme

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Celine Boudart, MD PhD

CONTACT

+3225553919; celine.boudart@hubruxelles.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The anaesthetist and the investigator will know which group the patient has been allocated to (dexmedetomidine sedation versus propofol-remifentanil sedation). The pumps used to administer these drugs will be concealed from the patient and the interventional cardiologist. The interventional cardiologist and the patient will not know which group the patient has been allocated to.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 16, 2026
• Study Start: April 9, 2026
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

BE (1)