Renal Function DisorderNCT05462938
Conscious Sedation for Transcatheter Aortic Valve Implantation
A study testing Continuous infusion of propofol and Continuous infusion of dexmedetomidine in people with Renal Function Disorder and Postoperative Delirium, run by University of Ioannina at 1 site in Greece.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Function Disorder, Postoperative Delirium, Adverse Event
- What is being tested?
- Continuous infusion of propofol and Continuous infusion of dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteGreece
- Study dates
- 11 Nov 2021to 15 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for TAVR
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study of Propofol Versus Dexmedetomidine for Conscious Sedation During Transcatheter Aortic Valve Implantation
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.
Read the 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.
- Being tested
- Continuous infusion of propofol, Continuous infusion of dexmedetomidine
- Keywords
- transcatheter aortic valve replacement, dexmedetomidine, propofol, conscious sedation, monitored anesthesia care
- Medical subject headings
- Emergence Delirium, Death, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous infusion of propofolDrug
Also called Prop Group
Sedation under continuous infusion of propofol. Small doses of fentanyl will be administered if needed.
Continuous infusion of dexmedetomidineDrug
Also called Dex Group
Sedation under continuous infusion of dexmedetomidine. Small doses of fentanyl will be administered if needed.
| Study group | Role | What they receive |
|---|---|---|
| Propofol group | Active comparator | Continuous infusion of propofol Receives: Drug: Continuous infusion of propofol |
| Dexmedetomidine group | Active comparator | Continuous infusion of dexmedetomidine Receives: Drug: Continuous infusion of dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Up to 30 days
Postoperative dellirium
Recording of postoperative delirium using the Confusion Assessment Method (CAM) score.
Measured: 48 hours
Secondary outcomes (21)
Death
The occurence of death
Measured: Up to 30 days
Neurocognitive level
Assessment of neurocognitive function of the patient with the use of the mini mental state examination (MMSE) score.
Measured: Up to 48 hours
Vasoactive and inotropic agents
The usage of norepinephrine, epinephrine, phenylephrine, ephedrine, nitroglycerin, atropine, or other relevant agents will be recorded as the cumulative dosage of each administered during the procedure.
Measured: Intraoperatively
Stroke
The occurrence of stroke after the procedure will be assessed as a binary outcome variable (yes/no).
Measured: Up to 30 days
Myocardial infraction
The occurrence of myocardial infraction after the procedure will be assessed as a binary outcome variable (yes/no).
Measured: Up to 30 days
Acute heart failure
The occurrence of acute heart failure after the procedure will be assessed as a binary outcome variable (yes/no).
Measured: Up to 30 days
Life threatening arrythmias
The occurrence of life threatening arrythmias after the procedure will be assessed as a binary outcome variable (yes/no).
Measured: Up to 30 days
Rehospitalization
The occurrence of rehospitalization will be assessed as a binary outcome variable (yes/no).
Measured: Up to 30 days
Pain intensity
Pain intensity will be recorded using the numerical rating scale (NRS).
Measured: Up to 48 hours
Headache
The occurrence of headache after the procedure will be assessed as a binary outcome variable (yes/no)
Measured: Up to 48 hours
Nausea/vomiting
The occurrence of nausea/vomiting after the procedure will be assessed by a 5-point scale (0 to 4, with 4 indicating the worse outcome).
Measured: Up to 48 hours
Pruritus
The occurrence of pruritus after the procedure will be assessed by an 11-point scale (0 to 10, with 10 indicating the worse outcome).
Measured: Up to 48 hours
Hypoxemia
The occurrence of hypoxemia after the procedure will be assessed by continuous monitoring of oxygen level (SpO2).
Measured: Up to 48 hours
Duration of sedation
The duration of sedation is defined as the time (minutes) from the start of the sedative agent administration to patient recovery (alert and able to communicate).
Measured: Intraoperatively
Procedural time
Procedural time is defined as the time (minutes) from the start of the procedure to last suture.
Measured: Intraoperatively
Rapid pacing time
Rapid pacing time is defined as the cumulative time (seconds) of rapid ventricular pacing performed during the procedure.
Measured: Intraoperatively
ICU length of stay
The cumulative length of stay in the cardiac intensive care unit (days) after the procedure.
Measured: Postoperatively and up to 30 days
Length of stay
The cumulative length of stay in the ward (days) after the procedure.
Measured: Postoperatively and up to 30 days
Patient satisfaction
Patient satisfaction will be assessed using the Likert satisfaction scale.
Measured: 24 hours
Cardiologist satisfaction
The satisfaction of the interventional cardiologists performing the procedure will be assessed by the Likert satisfaction scale.
Measured: 24 hours
Awareness
Occurrence of intraoperative awareness of the patient will be assessed using the Michigan Awareness Classification Instrument.
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start11 Nov 2021
- Primary completion15 Mar 2026
- Study completion15 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Function DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ioannina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agathi Karakosta, University of Ioannina
- Investigators
- Paraskevas Tseniklidis, MD, Principal investigator, University of Ioannina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05462938
- Sponsor's protocol ID
- 11772
- Status last verified
- May 2026
- First submitted
- 8 Jul 2022
- Last updated
- 6 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Propofol Versus Dexmedetomidine for Conscious Sedation During Transcatheter Aortic Valve Implantation
- ClinicalTrials.gov ID
- NCT05462938
- Acronym / sponsor ID
- 11772
- Keywords
- transcatheter aortic valve replacement, dexmedetomidine, propofol, conscious sedation, monitored anesthesia care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of IoanninaUniversity, hospital or other
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- 15 Mar 2026 (actual)
- Study completion
- 15 Mar 2026 (actual)
- First posted
- 18 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol group | Active comparator | Drug: Continuous infusion of propofolContinuous infusion of propofol |
| Dexmedetomidine group | Active comparator | Drug: Continuous infusion of dexmedetomidineContinuous infusion of dexmedetomidine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for TAVR
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous infusion of propofolAlso: Prop GroupSedation under continuous infusion of propofol. Small doses of fentanyl will be administered if needed. | Drug | Propofol group |
| Continuous infusion of dexmedetomidineAlso: Dex GroupSedation under continuous infusion of dexmedetomidine. Small doses of fentanyl will be administered if needed. | Drug | Dexmedetomidine group |
Primary outcome
Change of serum creatinine from baseline
Time frame: Up to 30 days
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).
Change of blood urea nitrogen (BUN) from baseline
Time frame: Up to 30 days
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).
Change of serum cystatin C from baseline
Time frame: Up to 30 days
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).
Change of glomerular filtration rate (GFR) from baseline using the Cockcoft-Gault equation
Time frame: Up to 30 days
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.
Change of glomerular filtration rate (GFR) from baseline using the MDRD equation
Time frame: Up to 30 days
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.
Postoperative dellirium
Time frame: 48 hours
Recording of postoperative delirium using the Confusion Assessment Method (CAM) score.
21 secondary outcomes
Death
Time frame: Up to 30 days
Neurocognitive level
Time frame: Up to 48 hours
Vasoactive and inotropic agents
Time frame: Intraoperatively
Stroke
Time frame: Up to 30 days
Myocardial infraction
Time frame: Up to 30 days
Acute heart failure
Time frame: Up to 30 days
Life threatening arrythmias
Time frame: Up to 30 days
Rehospitalization
Time frame: Up to 30 days
Pain intensity
Time frame: Up to 48 hours
Headache
Time frame: Up to 48 hours
Nausea/vomiting
Time frame: Up to 48 hours
Pruritus
Time frame: Up to 48 hours
Hypoxemia
Time frame: Up to 48 hours
Duration of sedation
Time frame: Intraoperatively
Procedural time
Time frame: Intraoperatively
Rapid pacing time
Time frame: Intraoperatively
ICU length of stay
Time frame: Postoperatively and up to 30 days
Length of stay
Time frame: Postoperatively and up to 30 days
Patient satisfaction
Time frame: 24 hours
Cardiologist satisfaction
Time frame: 24 hours
Awareness
Time frame: Up to 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paraskevas Tseniklidis, MD principal investigator
University of Ioannina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous infusion of propofol and Continuous infusion of dexmedetomidine in people with Renal Function Disorder and Postoperative Delirium, run by University of Ioannina at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of serum creatinine from baseline (time frame: Up to 30 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.