Clinical trial NCT05462938: Conscious Sedation for Transcatheter Aortic Valve Implantation
Official title: Comparative Study of Propofol Versus Dexmedetomidine for Conscious Sedation During Transcatheter Aortic Valve Implantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Renal Function Disorder
Postoperative Delirium
Adverse Event
Death
Satisfaction
Keywords: transcatheter aortic valve replacement
dexmedetomidine
propofol
conscious sedation
monitored anesthesia care
Lead sponsor: University of Ioannina
Sponsor class: OTHER
First posted: 2022-07-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Aortic valve stenosis is the most common heart valve disease among the elderly, and eventually may lead to heart failure. Its surgical replacement (SAVR) was the only definitive treatment, but this operation is considered to be of increased risk for morbidity and mortality. Also, there is a growing number of elderly with severe co-morbidities, who are considered as high risk patients, that cannot undergo such an operation. Transcatheter Aortic Valve Replacement (TAVR) offered an alternative method of treatment for these patients. Furthermore, its indications were expanded to intermediate risk patients due to its advantages over SAVR.

At first, general anesthesia was the most popular anesthetic method for TAVR. However, conscious sedation and Monitored Anesthesia Care (MAC) have emerged as advantageous alternatives, in terms of inotropic drug usage, procedural times, intensive care unit (ICU) and hospital length of stay. However, few data exist about the anesthetic agents that are most suitable for TAVR under MAC, with propofol and dexmedetomidine being the most popular of them.

This is a prospective comparative study of propofol versus dexmedetomidine used for MAC in TAVR procedures. The patients will be randomly allocated into two groups and will be sedated by continuous infusion of either propofol or dexmedetomidine during the TAVR procedure. These two groups will be assessed for the overall quality of the sedation method, the clinical outcomes, the adverse events and the duration of hospitalization. At the preoperative evaluation, detailed patients' medical history will be taken, their comorbidities, physique, heart echocardiography measurements, level of frailty, renal function and neurocognitive level will be assessed and recorded and, finally, signed consent will be obtained.

During the procedure, the depth of sedation will be monitored with the use of Patient State Index (PSI) and the fluctuation of arterial pressure, heart rate, and oxygen saturation, the administration of vasoactive agents and fluids, apnea episodes and diuresis will be also recorded. By the end of the procedure, the volume and type of contrast agent used, the type of the implanted valve and the duration of both the sedation and the operation will be documented. Throughout their hospitalization, adverse events, renal function and neurocognitive level will be recorded, along with the occurrence of postoperative delirium. After patients' discharge, their duration of hospitalization, both in cardiac intensive care unit and cardiology clinic will be recorded. Follow up of the patients will be completed after thirty days. All-cause mortality will be assessed at this point and there will be a detailed recording of any adverse events and/or re-hospitalization along with long-term assessment of renal and cognitive function.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for TAVR

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change of serum creatinine from baseline
timeFrame: Up to 30 days
measure: Change of blood urea nitrogen (BUN) from baseline
timeFrame: Up to 30 days
measure: Change of serum cystatin C from baseline
timeFrame: Up to 30 days
measure: Change of glomerular filtration rate (GFR) from baseline using the Cockcoft-Gault equation
timeFrame: Up to 30 days
measure: Change of glomerular filtration rate (GFR) from baseline using the MDRD equation
timeFrame: Up to 30 days
measure: Postoperative dellirium
timeFrame: 48 hours
Secondary outcomes:
measure: Death
timeFrame: Up to 30 days
measure: Neurocognitive level
timeFrame: Up to 48 hours
measure: Vasoactive and inotropic agents
timeFrame: Intraoperatively
measure: Stroke
timeFrame: Up to 30 days
measure: Myocardial infraction
timeFrame: Up to 30 days
measure: Acute heart failure
timeFrame: Up to 30 days
measure: Life threatening arrythmias
timeFrame: Up to 30 days
measure: Rehospitalization
timeFrame: Up to 30 days
measure: Pain intensity
timeFrame: Up to 48 hours
measure: Headache
timeFrame: Up to 48 hours
measure: Nausea/vomiting
timeFrame: Up to 48 hours
measure: Pruritus
timeFrame: Up to 48 hours
measure: Hypoxemia
timeFrame: Up to 48 hours
measure: Duration of sedation
timeFrame: Intraoperatively
measure: Procedural time
timeFrame: Intraoperatively
measure: Rapid pacing time
timeFrame: Intraoperatively
measure: ICU length of stay
timeFrame: Postoperatively and up to 30 days
measure: Length of stay
timeFrame: Postoperatively and up to 30 days
measure: Patient satisfaction
timeFrame: 24 hours
measure: Cardiologist satisfaction
timeFrame: 24 hours
measure: Awareness
timeFrame: Up to 30 days
Other outcomes:
Locations:
city: Ioannina
country: Greece
facility: Univesity Hospital of Ioannina
state: Epirus
Study officials:
affiliation: University of Ioannina
name: Paraskevas Tseniklidis, MD
role: PRINCIPAL_INVESTIGATOR
References: