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

Comparison of Procedural Sedation With Propofol and Dexmedetomidine During Transcatheter Aortic Valve Implantation Using the Transfemoral Approach: Randomized Double Blind Prospective Study

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.

Study Overview

• Status: Completed
• Conditions: Transcatheter Aortic Valve Replacement; Procedural Sedation
• Intervention / Treatment: Drug: Propofol; Drug: Dexmedetomidine

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 4

Contacts and Locations

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • UMC Ljubljana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Propofol; Procedural 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)	Drug: Propofol; Procedural sedation during TAVR procedure using propofol
Experimental: Dexmedetomidine; Procedural 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)	Drug: Dexmedetomidine; Procedural sedation during TAVR procedure using dexmedetomidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of procedural sedation with propofol or dexmedetomidine on cognitive function of patients	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)	3 days
Effect of procedural sedation with propofol or dexmedetomidine on appearance of postoperative delirium	The investigators will perform CAM-ICU delirium assesment method every 12 hours for 84 hours after the procedure, assesing appearance of postoperative delirium in the first 84 hours after the procedure	84 hours

Other Outcome Measures

Outcome Measure	Time Frame
Length of intensive care unit stay	30 days after the TAVR procedure
Duration of in-hospital stay	30 days after the TAVR procedure

Collaborators and Investigators

• Sponsor: University Medical Centre Ljubljana

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2019
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: November 3, 2018
• First Submitted That Met QC Criteria: November 19, 2018
• First Posted (Actual): November 20, 2018

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Propofol; Dexmedetomidine; Transcatheter Aortic Valve Replacement; Procedural Sedation
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Propofol; Dexmedetomidine
• Other Study ID Numbers: UMCLJTAVR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No