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

NCT ID: NCT03747432

Last Updated: 2023-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-15
• Study Completion Date: 2021-06-30

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.

Conditions

Transcatheter Aortic Valve Replacement; Procedural Sedation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

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)

Group Type: EXPERIMENTAL

Propofol

Intervention Type: DRUG

Procedural sedation during TAVR procedure using propofol

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)

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: DRUG

Procedural sedation during TAVR procedure using dexmedetomidine

Interventions

Propofol

Procedural sedation during TAVR procedure using propofol

Intervention Type: DRUG

Dexmedetomidine

Procedural sedation during TAVR procedure using dexmedetomidine

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Centre Ljubljana

OTHER

Sponsor Role: lead

Responsible Party

Pia Vovk

Doctor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

UMC Ljubljana

Ljubljana, , Slovenia

Countries

Slovenia

Other Identifiers

UMCLJTAVR

Identifier Type: -

Identifier Source: org_study_id