Comparison of Conscious Sedation With Propofol and Dexmedetomidine During Transcatheter Aortic Valve Implantation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03747432|
Recruitment Status : Recruiting
First Posted : November 20, 2018
Last Update Posted : February 19, 2019
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 conscious sedation (CS). From the start, TAVR was performed solely under general anaesthesia. Over time the procedure became routine and the anaesthesiologists started to commonly decide for CS. Many US and European retrospective studies have established CS 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 CS in everyday anaesthesia practice. Presently, reliable data from studies comparing different agents for CS for TAVR procedures is scarce. Most of it comes from retrospective nonrandomized trials. Propofol is a popular anaesthetic agent for CS. 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 CS 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 CS 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 CS with dexmedetomidine against those undergoing TAVR under CS with propofol. With the results the investigators aim to aid in defining the optimal anaesthetic agent for CS for TAVR and possibly other interventional cardiology procedures.
|Condition or disease||Intervention/treatment||Phase|
|Transcatheter Aortic Valve Replacement Conscious Sedation||Drug: Propofol Drug: Dexmedetomidine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Comparison of Conscious Sedation With Propofol and Dexmedetomidine During Transcatheter Aortic Valve Implantation Using the Transfemoral Approach: Randomized Double Blind Prospective Study|
|Actual Study Start Date :||January 15, 2019|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||July 2020|
Conscious sedation with propofol during the TAVR procedure (anticipated around 2 hours), dosage: 0,5-2,5 mg/kg/h for appropriate level of sedation - Ramsay sedation score 3-4)
Conscious sedation during TAVR procedure using propofol
Conscious sedation with dexmedetomidine during the TAVR procedure (anticipated around 2 hours), dosage: bolus of 0,5 mcg/kg during 10 minutes, then continuous infusion of 0,2-1 mcg/kg/h for appropriate level of sedation - Ramsay sedation score 3-4)
Conscious sedation during TAVR procedure using dexmedetomidine
- Effect of conscious sedation with propofol or dexmedetomidine on cognitive function of patients [ Time Frame: 3 days ]The investigators will perform cognitive function testing (Mini-Mental State Examination Test) one day before the procedure (baseline result) and 48 hours after the procedure (assesing change from baseline result)
- Effect of conscious sedation with propofol or dexmedetomidine on appearance of postoperative delirium [ Time Frame: 72 hours ]The investigators will perform CAM-ICU delirium assesment method every 12 hours for 72 hours after the procedure, assesing appearance of postoperative delirium in the first 72 hours after the procedure
- Length of intensive care unit stay [ Time Frame: 30 days after the TAVR procedure ]
- Duration of in-hospital stay [ Time Frame: 30 days after the TAVR procedure ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03747432
|Contact: Pia Vovk, MDfirstname.lastname@example.org|
|Ljubljana, Slovenia, 1000|