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临床试验/NCT07532733
NCT07532733招募中不适用

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

Erasme University Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年4月22日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
80
试验地点
1
主要终点
the occurrence of an intraoperative respiratory event during a TAVI procedure performed under sedation

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Care Provider)

盲法说明

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.

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • -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.

排除标准

  • 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).

研究组 & 干预措施

sedation dexmedetomidine

Experimental

干预措施: Sedation with dexmedetomidine (Drug)

sedation propofol-remifentanil

Active Comparator

干预措施: sedation propofol and remifentanil (Drug)

结局指标

主要结局

the occurrence of an intraoperative respiratory event during a TAVI procedure performed under sedation

时间窗: during sedation for TAVI procedure

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

次要结局

  • 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)
  • Tolerance and safety(up to 30 days)

研究者

发起方
Erasme University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Céline Boudart

MD PhD

Erasme University Hospital

研究点 (1)

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