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

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ClinicalTrials.gov Identifier: NCT03747432
Recruitment Status : Recruiting
First Posted : November 20, 2018
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
Pia Vovk, University Medical Centre Ljubljana

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 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Propofol
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)
Drug: Propofol
Conscious sedation during TAVR procedure using propofol

Experimental: Dexmedetomidine
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)
Drug: Dexmedetomidine
Conscious sedation during TAVR procedure using dexmedetomidine




Primary Outcome Measures :
  1. 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)

  2. 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


Other Outcome Measures:
  1. Length of intensive care unit stay [ Time Frame: 30 days after the TAVR procedure ]
  2. Duration of in-hospital stay [ Time Frame: 30 days after the TAVR procedure ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Pia Vovk, MD piavovk@gmail.com

Locations
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Slovenia
UMC Ljubljana Recruiting
Ljubljana, Slovenia, 1000
Sponsors and Collaborators
University Medical Centre Ljubljana

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Responsible Party: Pia Vovk, Doctor of Medicine, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT03747432    
Other Study ID Numbers: UMCLJTAVR
First Posted: November 20, 2018    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Pia Vovk, University Medical Centre Ljubljana:
Transcatheter Aortic Valve Replacement
Conscious Sedation
Propofol
Dexmedetomidine
Additional relevant MeSH terms:
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Dexmedetomidine
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action