NCT03747432

Comparison of Procedural Sedation With Propofol and Dexmedetomidine During Transcatheter Aortic Valve Implantation

Completed Phase 4 Last updated 10 May 2023

What this trial tests

Phase 4 trial testing Propofol in Transcatheter Aortic Valve Replacement in 70 participants. Completed in 30 June 2021.

Timeline

15 January 2019

Primary endpoint
30 June 2021

30 June 2021

Quick facts

Lead sponsor	University Medical Centre Ljubljana
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	other
Enrollment	70
Start date	15 January 2019
Primary completion	30 June 2021
Estimated completion	30 June 2021
Sites	1 location across Slovenia

Drugs / interventions tested

• Propofol (Propofol) — full drug profile →
• Dexmedetomidine (dexmedetomidine) — full drug profile →

Conditions studied

• Transcatheter Aortic Valve Replacement — all drugs for Transcatheter Aortic Valve Replacement →
• Procedural Sedation — all drugs for Procedural Sedation →

Sponsor

University Medical Centre Ljubljana

Who can join

18 and older, any sex, with Transcatheter Aortic Valve Replacement or Procedural Sedation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.