Conscious Sedation for Transcatheter Aortic Valve Implantation

NCT05462938 | Completed

• 1 other identifier: 11772
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

transcatheter aortic valve replacement; dexmedetomidine; propofol; conscious sedation; monitored anesthesia care

Outcome Measures

Primary Outcomes (6)

• Change of serum creatinine from baseline

  Assessment of renal function by serial measurements of serum creatinine (mg/dL) at four different time points (at baseline, at 24 hours, at 48 hours and at 30 days postoperatively).

  Up to 30 days

• Change of blood urea nitrogen (BUN) from baseline

  Assessment of renal function by serial measurements of BUN (mg/dL) at four different time points (at baseline, at 24 hours, at 48 hours and at 30 days postoperatively).

  Up to 30 days

• Change of serum cystatin C from baseline

  Assessment of renal function by serial measurements of serum cystatin C (mg/l) at four different time points (at baseline, at 24 hours, at 48 hours and at 30 days postoperatively).

  Up to 30 days

• Change of glomerular filtration rate (GFR) from baseline using the Cockcoft-Gault equation

  Assessment of renal function by serial calculations of GFR (ml/min) at four different time points (at baseline, at 24 hours, at 48 hours and at 30 days postoperatively) using the Cockcoft-Gault equation.

  Up to 30 days

• Change of glomerular filtration rate (GFR) from baseline using the MDRD equation

  Assessment of renal function by serial calculations of GFR (ml/min) at four different time points (at baseline, at 24 hours, at 48 hours and at 30 days postoperatively) using the MDMR equation.

  Up to 30 days

• Postoperative dellirium

  Recording of postoperative delirium using the Confusion Assessment Method (CAM) score.

  48 hours

Secondary Outcomes (21)

• Death

  Up to 30 days

• Neurocognitive level

  Up to 48 hours

• Vasoactive and inotropic agents

  Intraoperatively

• Stroke

  Up to 30 days

• Myocardial infraction

  Up to 30 days

Study Arms (2)

Propofol group

ACTIVE COMPARATOR

Continuous infusion of propofol

Drug: Continuous infusion of propofol

Dexmedetomidine group

ACTIVE COMPARATOR

Continuous infusion of dexmedetomidine

Drug: Continuous infusion of dexmedetomidine

Interventions

Continuous infusion of propofol DRUG

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

Also known as: Prop Group

Propofol group

Continuous infusion of dexmedetomidine DRUG

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

Also known as: Dex Group

Dexmedetomidine group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for TAVR

You may not qualify if:

• Emergency operation
• Pre-existing neurocognitive dysfunction (Mini Mental State Examination score \<23)
• Inability to cooparate - communicate
• End Stage Renal Disease
• Allergy to any of the administrated drugs
• No consent

Sponsors & Collaborators

• University of Ioannina: lead

Study Sites (1)

Univesity Hospital of Ioannina

Ioannina, Epirus, Greece

Location

MeSH Terms

Conditions

Emergence Delirium; Death; Personal Satisfaction

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Behavior

Study Officials

• Paraskevas Tseniklidis, MD

  University of Ioannina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anaesthesiology

Study Record Dates

• First Submitted: July 8, 2022
• First Posted: July 18, 2022
• Study Start: November 11, 2021
• Primary Completion: March 15, 2026
• Study Completion: March 15, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Locations

GR (1)