Clinical trial NCT03747432: Comparison of Procedural Sedation With Propofol and Dexmedetomidine During Transcatheter Aortic Valve Implantation
Official title: Comparison of Procedural Sedation With Propofol and Dexmedetomidine During Transcatheter Aortic Valve Implantation Using the Transfemoral Approach: Randomized Double Blind Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Transcatheter Aortic Valve Replacement
Procedural Sedation
Keywords: Transcatheter Aortic Valve Replacement
Procedural Sedation
Propofol
Dexmedetomidine
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2018-11-20
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Aortic valve stenosis is the most common valvular heart disease in the developed world, affecting 3,9% of population over 70 years of age. If untreated it carries a poor prognosis, leading to heart failure and death in 2 years after first symptom presentation. Treatment of choice for severe aortic stenosis is surgical aortic valve replacement. A new treatment option for severe aortic stenosis emerged in the last decade - Transcatheter Aortic Valve Replacement (TAVR). This minimally invasive method was formerly reserved for high risk patients deemed unfit for surgical aortic valve replacement. Increasing use throughout the developed world and recent studies have established TAVR as a safe and viable treatment option also for intermediate-risk patients. TAVR not only enables a less aggressive surgical approach, but also a less invasive type of anaesthesia. Anaesthesiologists are trying to modify the type of anaesthesia in the way of minimally invasive approach, aiming to improve the overall outcome.

TAVR can be performed under general anaesthesia or procedural sedation (PS). From the start, TAVR was performed solely under general anaesthesia. Over time the procedure became routine and the anaesthesiologists started to commonly decide for PS. Many US and European retrospective studies have established PS to be a safe and compelling method of anaesthetic care for TAVR procedures with a favorable perioperative course, less complications, shorter intensive care unit and in-hospital stay and lower early mortality, when performed by an experienced anaesthesia team. There are many anaesthesia agents currently accepted for PS in everyday anaesthesia practice. Presently, reliable data from studies comparing different agents for PS for TAVR procedures is scarce. Most of it comes from retrospective nonrandomized trials. Propofol is a popular anaesthetic agent for PS. According to current studies, it is a safe anaesthetic agent with favorable pharmacokinetic and pharmacodynamic profiles with quite low incidence of side effects. In recent years, dexmedetomidine has been commonly used for PS having analgesic properties inclusive of its anaesthetic properties. In addition, dexmedetomidine is associated with a lesser degree of respiratory depression as to other anaesthetic agents. Patient comfort is also believed to be improved with dexmedetomidine. Studies comparing outcomes of PS with propofol versus dexmedetomidine for different non-cardiac and interventional procedures showed benefits of dexmedetomidine, owing to its analgesic properties and preferable respiratory parameters.

The aim of this study is to compare the outcome of patients undergoing TAVR under PS with dexmedetomidine against those undergoing TAVR under PS with propofol. With the results the investigators aim to aid in defining the optimal anaesthetic agent for PS for TAVR and possibly other interventional cardiology procedures.


Eligibility criteria: Inclusion Criteria:

* Admission to University Medical Centre Ljubljana cardiology ward for TAVR using transfemoral approach
* Voluntary agreement to participate in the study
* Aged over 18 years

Exclusion Criteria:

* Disagreement to participate in the study
* Unable to voluntarily agree to participate in the study
* Unable to participate in Mini-Mental State Examination
* History of alcohol abuse
* Diagnosed progressive dementia
* History of cerebrovascular insult

Primary outcomes:
measure: Effect of procedural sedation with propofol or dexmedetomidine on cognitive function of patients
timeFrame: 3 days
measure: Effect of procedural sedation with propofol or dexmedetomidine on appearance of postoperative delirium
timeFrame: 84 hours
Secondary outcomes:
Other outcomes:
measure: Length of intensive care unit stay
timeFrame: 30 days after the TAVR procedure
measure: Duration of in-hospital stay
timeFrame: 30 days after the TAVR procedure
Locations:
city: Ljubljana
country: Slovenia
facility: UMC Ljubljana
Study officials:
References: