Mitral Valve InsufficiencyPhase 3NCT05696509
Influence of Anesthetics on Clinical Outcome in Mitral and Aortic Valve Replacement in Adults
A Phase 3 study testing Propofol, Isoflurane and Sevoflurane in people with Mitral Valve Insufficiency and Aortic Valve Insufficiency, run by Astana Medical University at 1 site in Kazakhstan.
Trial summary
Abstract Anaesthetic support for cardiac surgery significantly influences the course of the intraoperative period and the success of the postoperative period. Total intravenous anaesthesia and inhalation anaesthesia are the traditional methods of anaesthesia in cardiac surgery. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Mitral Valve Insufficiency, Aortic Valve Insufficiency
- What is being tested?
- Propofol, Isoflurane and Sevoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteKazakhstan
- Study dates
- 3 Jan 2020to 16 Oct 2022
- Phase
- Phase 3
- 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The age is between 40-60 years old;
- Mitral valve insufficiency grade 3-4;
- Aortic valve insufficiency grade 3-4;
- Participants of both sexes will be included in the study;
- Signed informed consent.
Who cannot join
- pregnancy (risk to the baby and the mother)
- allergenic patients (anaphylactic shock).
- vulnerable groups.
- current congestive heart failure;
- current unstable angina pectoris;
- preoperative hemodynamic instability, defined as the use of vasopressors;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Anesthetics on Clinical Outcome in Mitral and Aortic Valve Replacement in Adults: a Randomized Clinical Trial
Abstract Anaesthetic support for cardiac surgery significantly influences the course of the intraoperative period and the success of the postoperative period. Total intravenous anaesthesia and inhalation anaesthesia are the traditional methods of anaesthesia in cardiac surgery. However, there are few studies assessing the effectiveness of surgical aggression protection in cardiac surgery.
Objectives: To study the effect of anesthetics on clinical outcome after mitral and aortic valve replacement in adults.
Read more
Methods. The data of 75 patients operated in the Cardiosurgery Department of the Medical Center Hospital of the Presidential Administration of the Republic of Kazakhstan were included in the study. All patients underwent mitral, aortic valve replacement/plasty under cardiopulmonary bypass (CPB) conditions.
All patients were divided into 3 groups according to the type of anaesthesia: the first (1) group patients anaesthetised with propofol (P), the second group with sevoflurane (S), and the last one is with isoflurane (I).
To maintain anaesthesia in Group 1 propofol was used as anaesthetic in a dose of 6 mg/kg/h intravenously on perfusion. In Group 2 the anaesthetic used was sevoflurane in a dose of 1.7-1.9 MAC. Group 3 used isoflurane in the dose of 1.1-1.2 MAC as anaesthetic. Statistical analysis was done by the method of single factor analysis of variance and Kruskal Wallis criterion.
Read the detailed description
This study includes data from 90 patients operated in the Cardiosurgery Department of the Medical Center Hospital of the Presidential Administration of the Republic of Kazakhstan were included in the study. All patients underwent mitral, aortic valve replacement/plasty under cardiopulmonary bypass (CPB) conditions. This research work was conducted between 2020 and 2022. To calculate the sample size, the investigators used the formula n=t2*D*N/confidence interval*N+t2*α, which will allow to identify the static significance of the study.
All patients were divided into 3 groups according to the type of anaesthesia: the first (1) group patients anaesthetised with propofol (P), the second group with sevoflurane (S), and the last one is with isoflurane (I).
The study was conducted in 5 stages:
- Initial haemodynamic parameters and oxygen transport function of the patient's blood before anaesthesia were determined;
- After tracheal intubation;
- Before the CPB;
- After the CPB;
- The post-operative period until the patient is transferred to the specialized department.
Before induction into anaesthesia, haemodynamic monitoring was started on admission to the operating theatre using a Nihon Kohden monitor (Japan). The right radial artery was catheterised for invasive monitoring of systemic arterial pressure and arterial blood sampling, and a catheter was then inserted into the central jugular vein (under ultrasound machine control) and guided into the right atrium for mixed venous blood sampling.
Cardiac stroke volume was determined by transthoracic echocardiography (CS=end diastolic volume - end systolic volume). Cardiac output (CO=CS x heart rate), cardiac index (CI=CO/body surface area) were determined. the investigators determined blood oxygen content using the formula CaO2 (arterial ABB) and CvO2 (central mixed venous ABB) = [(1.34 × Hb × SO2) + (PO2 × 0.031)] / 100. Arteriovenous difference = CaO2-CvO2. Oxygen delivery was determined using the formula (DO2 = CI* CaO2). Oxygen consumption (VO2 = Cardiac index (CI)*AVD or VO2 = CO × (CaO2 - CvO2) ~ CO × Hb × 1.34 × (SaO2 - SvO2) / 100).
In the second stage, after tracheal intubation, indirect calorimetry was used to determine VO2, energy expenditure during anaesthesia using a Spirometry device (Oxford, UK), which was connected to an endotracheal tube and continuously showed oxygen demand and energy expenditure. A transesophageal echocardiography sensor was used to determine cardiac output. Additionally, the cardiac output was determined by Fick's formula. The same tests (cardiac output, cardiac index, consumption, oxygen delivery, energy expenditure) were performed in the third and fourth stages of anaesthesia. In the last stage, the consumption of muscle relaxants and opioid analgesics was calculated to assess the pharmaco-efficiency of anaesthetics. The time of extubation and the time of transfer of the patient to the specialized department were determined.
All patients continued antihypertensive medication both before and on the day of surgery to prevent the development of withdrawal syndrome and to reduce the risk of perioperative myocardial ischaemia.
- Being tested
- Propofol, Isoflurane, Sevoflurane
- Keywords
- clinical outcome, sevoflurane, isoflurane, propofol, Mitral Valve Insufficiency, Aortic Valve Insufficiency
- Medical subject headings
- Mitral Valve Insufficiency, Aortic Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Also called Anesthesia
To maintain anaesthesia in Group 1 P, propofol was used as an anaesthetic in a dose of 4-6 mg/kg/h intravenously on a perfusor.
IsofluraneDrug
Also called Anesthesia
Isoflurane was used as an anaesthetic in a dose of - 1.1-1.2 MAC
SevofluraneDrug
Also called Anesthesia
sevoflurane was used as an anaesthetic in a dose of - 1.7-1.9 MAC
| Study group | Role | What they receive |
|---|---|---|
| Propofol | Other | Anesthetic Receives: Drug: Propofol |
| Isofluran | Other | Anesthetic Receives: Drug: Isoflurane |
| Sevofluran | Other | Anesthetic Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiac index
The cardiac stroke (CS) volume was determined by transthoracic echocardiography (CS=end diastolic volume-end systolic volume). There were also determined the cardiac output (CO=CS x heart rate), cardiac index (CI=CO/body surface area).
Measured: 1 year
Oxygen consumption
Oxygen consumption (VO2 = Cardiac index *AVD or VO2 = CO × (CaO2 - CvO2) ~ CB × Hb × 1,34 × (SaO2 - SvO2) / 100), oxygen utilization factor (KYO2) = VO2 / DO2 × 100 = [(CaO2 - CvO2) / CaO2] × 100.
Measured: 1 year
Oxygen delivery
The oxygen delivery was found by formula (DO2 = CI* CaO2)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start3 Jan 2020
- Primary completion13 Oct 2022
- Study completion16 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valve InsufficiencyStudies 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 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astana Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bekzat Baiterek, Astana Medical University
- Investigators
- Alibek Kh Mustafin, Professor, Study chair, Astana Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05696509
- Sponsor's protocol ID
- AMU3
- Status last verified
- Jan 2023
- First submitted
- 21 Dec 2022
- Last updated
- 25 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To study the effect of anesthetics on clinical outcome after mitral and aortic valve replacement in adults.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Anesthetics on Clinical Outcome in Mitral and Aortic Valve Replacement in Adults: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05696509
- Acronym / sponsor ID
- AMU3
- Keywords
- clinical outcome, sevoflurane, isoflurane, propofol, Mitral Valve Insufficiency, Aortic Valve Insufficiency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Astana Medical UniversityUniversity, hospital or other
- Study start
- 3 Jan 2020 (actual)
- Primary completion
- 13 Oct 2022 (actual)
- Study completion
- 16 Oct 2022 (actual)
- First posted
- 25 Jan 2023 (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.
Abstract Anaesthetic support for cardiac surgery significantly influences the course of the intraoperative period and the success of the postoperative period. Total intravenous anaesthesia and inhalation anaesthesia are the traditional methods of anaesthesia in cardiac surgery. However, there are few studies assessing the effectiveness of surgical aggression protection in cardiac surgery.
Objectives: To study the effect of anesthetics on clinical outcome after mitral and aortic valve replacement in adults.
Methods. The data of 75 patients operated in the Cardiosurgery Department of the Medical Center Hospital of the Presidential Administration of the Republic of Kazakhstan were included in the study. All patients underwent mitral, aortic valve replacement/plasty under cardiopulmonary bypass (CPB) conditions.
All patients were divided into 3 groups according to the type of anaesthesia: the first (1) group patients anaesthetised with propofol (P), the second group with sevoflurane (S), and the last one is with isoflurane (I).
To maintain anaesthesia in Group 1 propofol was used as anaesthetic in a dose of 6 mg/kg/h intravenously on perfusion. In Group 2 the anaesthetic used was sevoflurane in a dose of 1.7-1.9 MAC. Group 3 used isoflurane in the dose of 1.1-1.2 MAC as anaesthetic. Statistical analysis was done by the method of single factor analysis of variance and Kruskal Wallis criterion.
Detailed description
This study includes data from 90 patients operated in the Cardiosurgery Department of the Medical Center Hospital of the Presidential Administration of the Republic of Kazakhstan were included in the study. All patients underwent mitral, aortic valve replacement/plasty under cardiopulmonary bypass (CPB) conditions. This research work was conducted between 2020 and 2022. To calculate the sample size, the investigators used the formula n=t2*D*N/confidence interval*N+t2*α, which will allow to identify the static significance of the study.
All patients were divided into 3 groups according to the type of anaesthesia: the first (1) group patients anaesthetised with propofol (P), the second group with sevoflurane (S), and the last one is with isoflurane (I).
The study was conducted in 5 stages:
- Initial haemodynamic parameters and oxygen transport function of the patient's blood before anaesthesia were determined;
- After tracheal intubation;
- Before the CPB;
- After the CPB;
- The post-operative period until the patient is transferred to the specialized department.
Before induction into anaesthesia, haemodynamic monitoring was started on admission to the operating theatre using a Nihon Kohden monitor (Japan). The right radial artery was catheterised for invasive monitoring of systemic arterial pressure and arterial blood sampling, and a catheter was then inserted into the central jugular vein (under ultrasound machine control) and guided into the right atrium for mixed venous blood sampling.
Cardiac stroke volume was determined by transthoracic echocardiography (CS=end diastolic volume - end systolic volume). Cardiac output (CO=CS x heart rate), cardiac index (CI=CO/body surface area) were determined. the investigators determined blood oxygen content using the formula CaO2 (arterial ABB) and CvO2 (central mixed venous ABB) = [(1.34 × Hb × SO2) + (PO2 × 0.031)] / 100. Arteriovenous difference = CaO2-CvO2. Oxygen delivery was determined using the formula (DO2 = CI* CaO2). Oxygen consumption (VO2 = Cardiac index (CI)*AVD or VO2 = CO × (CaO2 - CvO2) ~ CO × Hb × 1.34 × (SaO2 - SvO2) / 100).
In the second stage, after tracheal intubation, indirect calorimetry was used to determine VO2, energy expenditure during anaesthesia using a Spirometry device (Oxford, UK), which was connected to an endotracheal tube and continuously showed oxygen demand and energy expenditure. A transesophageal echocardiography sensor was used to determine cardiac output. Additionally, the cardiac output was determined by Fick's formula. The same tests (cardiac output, cardiac index, consumption, oxygen delivery, energy expenditure) were performed in the third and fourth stages of anaesthesia. In the last stage, the consumption of muscle relaxants and opioid analgesics was calculated to assess the pharmaco-efficiency of anaesthetics. The time of extubation and the time of transfer of the patient to the specialized department were determined.
All patients continued antihypertensive medication both before and on the day of surgery to prevent the development of withdrawal syndrome and to reduce the risk of perioperative myocardial ischaemia.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Propofol | Other | Drug: PropofolAnesthetic |
| Isofluran | Other | Drug: IsofluraneAnesthetic |
| Sevofluran | Other | Drug: SevofluraneAnesthetic |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- The age is between 40-60 years old;
- Mitral valve insufficiency grade 3-4;
- Aortic valve insufficiency grade 3-4;
- Participants of both sexes will be included in the study;
- Signed informed consent.
Key exclusion criteria (6 listed)
- pregnancy (risk to the baby and the mother)
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 |
|---|---|---|
| PropofolAlso: AnesthesiaTo maintain anaesthesia in Group 1 P, propofol was used as an anaesthetic in a dose of 4-6 mg/kg/h intravenously on a perfusor. | Drug | Propofol |
| IsofluraneAlso: AnesthesiaIsoflurane was used as an anaesthetic in a dose of - 1.1-1.2 MAC | Drug | Isofluran |
| SevofluraneAlso: Anesthesiasevoflurane was used as an anaesthetic in a dose of - 1.7-1.9 MAC | Drug | Sevofluran |
Primary outcome
cardiac index
Time frame: 1 year
The cardiac stroke (CS) volume was determined by transthoracic echocardiography (CS=end diastolic volume-end systolic volume). There were also determined the cardiac output (CO=CS x heart rate), cardiac index (CI=CO/body surface area).
Oxygen consumption
Time frame: 1 year
Oxygen consumption (VO2 = Cardiac index *AVD or VO2 = CO × (CaO2 - CvO2) ~ CB × Hb × 1,34 × (SaO2 - SvO2) / 100), oxygen utilization factor (KYO2) = VO2 / DO2 × 100 = [(CaO2 - CvO2) / CaO2] × 100.
Oxygen delivery
Time frame: 1 year
The oxygen delivery was found by formula (DO2 = CI* CaO2)
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 25 Jan 2023.
- Individual participant dataSharing planned: No. To study the effect of anesthetics on clinical outcome after mitral and aortic valve replacement in adults.
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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.
Alibek Kh Mustafin, Professor study chair
Astana Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Propofol, Isoflurane and Sevoflurane in people with Mitral Valve Insufficiency and Aortic Valve Insufficiency, run by Astana Medical University at 1 site in Kazakhstan.
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 5 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 25 Jan 2023. 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 Kazakhstan. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
cardiac index (time frame: 1 year). The study lists 3 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 25 Jan 2023.