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Conscious Sedation for Transcatheter Aortic Valve Implantation

NCT05462938 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2026-05-06

No results posted yet for this study

Summary

Aortic valve stenosis is the heart valve disease with the highest prevalence among the elderly, and may lead to heart failure. Until recently, the only definitive treatment was surgical replacement (SAVR). However, the increased risk associated with the surgical procedure excluded patients with multiple co-morbidities. As the population is aging and more and more patients may present with aortic stenosis, the need of a less invasive approach has emerged. Transcatheter Aortic Valve Replacement (TAVR) offered an alternative therapy for these high risk patients. This new method has seen worldwide acceptance, has been proven very beneficial for these patients, and therefore its indications have been expanded to intermediate risk patients, as well. Until recently, general anesthesia was the primary anesthetic technique for TAVR, but conscious sedation or monitored anesthesia care (MAC) is gaining more and more popularity lately. Our knowledge regarding the comparison between general anesthesia and MAC in TAVR procedures is derived mainly from observational studies and few randomized trials. MAC seems to be associated with less inotropic drug usage, shorter procedural times, shorter intensive care unit (ICU) and hospital length of stay. However, according to published data, there were no differences in 30-day mortality and complications between these two techniques.

Even less are known about the most suitable anesthetic agent for MAC during TAVR. Many drugs have been used, with propofol and dexmedetomidine being the most popular. However, there are only few comparative studies and their results are not conclusive.

This study compares MAC under propofol and MAC under dexmedetomidine for TAVR in order to examine which method of conscious sedation comes with more beneficial postoperative outcomes for the patients.

Conditions

  • Renal Function Disorder
  • Postoperative Delirium
  • Adverse Event
  • Death
  • Satisfaction

Interventions

DRUG

Continuous infusion of propofol

Sedation under continuous infusion of propofol. Small doses of fentanyl will be administered if needed.

DRUG

Continuous infusion of dexmedetomidine

Sedation under continuous infusion of dexmedetomidine. Small doses of fentanyl will be administered if needed.

Sponsors & Collaborators

  • University of Ioannina

    lead OTHER

Principal Investigators

  • Paraskevas Tseniklidis, MD · University of Ioannina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-11
Primary Completion
2026-03-15
Completion
2026-03-15

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05462938 on ClinicalTrials.gov