Coronary Artery DiseaseNCT05514652
Anesthesia Standard Operating Procedure During On-pump Coronary Artery Bypass Grafting
A study testing Low opioid anesthesia in people with Coronary Artery Disease and Low Cardiac Output Syndrome, run by Heart Institute, Ministry of Health of Ukraine at 1 site in Ukraine.
Trial summary
Background: Despite improvements in surgical and anesthesia procedures over the past 15 years complications during cardiac surgery still remain high. Bridgewater B et al. describes mortality during on-pump coronary artery bypass grafting (CABG) at 2%-3%, and the rate postoperative complications about 20%-30%. Read more about this study
- Who is it for?
- Ages 44 to 65 years
- Conditions the study is for
- Coronary Artery Disease, Low Cardiac Output Syndrome, Atrial Fibrillation
- What is being tested?
- Low opioid anesthesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUkraine
- Study dates
- 1 Dec 2018to 1 Dec 2022
- 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 44 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age from 44 to 65 years,
- nn ejection fraction > 30%,
- operational risk assessment for EuroSCORE II <5%,
- on-pump coronary artery bypass grafting
Who cannot join
- patient's refusal
- off-pump coronary artery bypass grafting
- the need for additional intervention on the heart
Trial locations and contacts
1 site in 1 country.
Ukraine1 site
Heart Institute Ministry of Health of Ukraine
Kyiv, Kyiv Regio, 02660
About this study
Official title: Development of Anesthesia Standard Operating Procedure During On-pump Coronary Artery Bypass Grafting Due to Coronary Heart Disease
Background: Despite improvements in surgical and anesthesia procedures over the past 15 years complications during cardiac surgery still remain high. Bridgewater B et al. describes mortality during on-pump coronary artery bypass grafting (CABG) at 2%-3%, and the rate postoperative complications about 20%-30%. At the same time, the standard of care in patients undergoingon-pump CABG is not fully established.
Hypothesis, Research Need: Use of multimodal low-dose opioid anesthesia during CABG decreases inflammatory response and the incidence of early postoperative cardiac complications due to a reduction in interleukin-6.
Read more
Methodology: According to anesthesia standard protocol, all patients were divided into two groups - study group with multimodal low-dose opioid anesthesia (60 patients) and control group with a high-dose opioid anesthesia (60 patients). Primary (IL-6 at the end of the operation) and secondary clinical outcomes (postoperative atrial fibrillation (POAF), low cardiac output syndrome (LCOS), duration of mechanical ventilation (MV), length of intensive care unit (ICU) stay, length of hospital stay) were compared between the groups.
Analysis Tools: Clinical observations; instrumental research methods (electrocapdiography, echocardiography); labs (blood gases, hemoglobin, electrolytes); enzyme-linked immunosorbent assay (IL-6); statistical (Student's t-test, Mann-Whitney U test, χ2-test, correlation analysis).
Expected Outcomes: Use of multimodal low-dose opioid anesthesia during CABG will decrease inflammatory response (lower levels of IL-6 at the end of the surgery) and the incidence of early postoperative cardiac complications, expressed as lower incidence of LCOS and POAF, lower duration of MV and lower length of ICU stay.
- Conditions
- Coronary Artery Disease, Low Cardiac Output Syndrome, Atrial Fibrillation, Postoperative Complications
- Being tested
- Low opioid anesthesia
- Keywords
- coronary artery bypass grafting, cardiopulmonary bypass, coronary artery disease, low cardiac output syndrome, low-dose opioid anesthesia, postoperarive atrial fibrillation, IL-6
- Medical subject headings
- Coronary Artery Disease, Cardiac Output, Low, Atrial Fibrillation, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low opioid anesthesiaDrug
Multimodal low-dose opioid protocol for anesthesia based on ketamine, lidocaine and dexmedetomidine
| Study group | Role | What they receive |
|---|---|---|
| First group | Experimental | Multimodal low-opioid protocol provided for induction of anesthesia with intravenous (iv) propofol administration using the dosage of 1.5-2 mg/kg at 40 mg in interval of 10-15 seconds, iv fentanyl dosage 1-1.5 μg/kg and iv pipecuronium bromide dosage of 0.1 mg/kg. Before intubation of the trachea, a lidocaine 1 mg / kg bolus was added intravenously, with the simultaneous establishment of a continuous infusion at a dose of 1.5-2 mg/kg/h. All patients were administered a bolus of ketamine (0.5 mg/kg) and were started continuous infusion dexmedetomidine at a dose 0.7 μg/kg/h. If indicated fentanyl was used as additional analgesic during surgery by bolus injection. Depth of anesthesia was monitored with bispectral index; the dosage of sevoflurane from 1,5vol% to 2,5vol% was titrated to maintain BIS values from 40 to 60. Receives: Drug: Low opioid anesthesia |
| Second group | Active comparator | Routine opioid protocol of anesthesia provided for induction of anesthesia with the iv administration of propofol dosage of 1.5-2 mg/kg at 40 mg in interval of 15-20 seconds, iv fentanyl at a dose of 1-1.5 μg/kg and iv pipecuronium bromide dosage of 0.1 mg/kg. For analgesia, bolus injections of fentanyl were used at a dose of 8-10 μg/kg for the entire duration of the operation, muscle relaxation - pipecuronium bromide at a dose of 0.1 mg/kg. Depth of anesthesia was monitored with bispectral index; the dosage of sevoflurane from 1,5vol% to 2,5vol% was titrated to maintain BIS values from 40 to 60. Receives: Drug: Low opioid anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of concentration of IL-6 in venous blood plasma immediately after the surgery
Measured: immediately after surgery
Number of people with low cardiac output syndrome
Postoperative low cardiac output syndrome (LCOS) was defined as hemodynamic instability requiring continued pharmacologic support with 2 inotropic medications (epinephrine, milrinone, dobutamine) on postoperative day 1
Measured: immediately after the surgery
Number of people with postoperative atrial fibrillation
Postoperative atrial fibrillation was defined as first appeared in the period immediately after surgery
Measured: immediately after the surgery
Duration of mechanical ventilation
The decision about the extubation was made on the basis of following clinical criteria: recovering from muscle relaxation and anesthesia; patients is easy to rouse, neurologically intact, lift head and sticks out tongue; stable hemodynamics (heart rate and blood pressure are within ordered parameters, bleeding is controlled); spontaneous muscle movement with stable respiratory rate and adequate oxygenation, which was confirmed by arterial blood gases (SaO2 >92 %, on FiO2 <50%).
Measured: immediately after the surgery
The length of ICU stay
Measured: immediately after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start1 Dec 2018
- Primary completion1 Oct 2021
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heart Institute, Ministry of Health of Ukraine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maruniak Stepan, Heart Institute, Ministry of Health of Ukraine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05514652
- Sponsor's protocol ID
- 20180001
- Status last verified
- Aug 2022
- First submitted
- 19 Aug 2022
- Last updated
- 24 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stepan M, Oleh L, Oleksandr D, Justyna S. Effects of multimodal low-opioid anesthesia protocol during on-pump coronary artery bypass grafting: a prospective cohort study. J Cardiothorac Surg. 2023 Oct 6;18(1):272. doi: 10.1186/s13019-023-02395-y.
PubMed 37803334
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Anesthesia Standard Operating Procedure During On-pump Coronary Artery Bypass Grafting Due to Coronary Heart Disease
- ClinicalTrials.gov ID
- NCT05514652
- Acronym / sponsor ID
- 20180001
- Conditions
- Coronary Artery Disease, Low Cardiac Output Syndrome, Atrial Fibrillation, Postoperative Complications
- Keywords
- coronary artery bypass grafting, cardiopulmonary bypass, coronary artery disease, low cardiac output syndrome, low-dose opioid anesthesia, postoperarive atrial fibrillation, IL-6
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Heart Institute, Ministry of Health of UkraineUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 24 Aug 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.
Background: Despite improvements in surgical and anesthesia procedures over the past 15 years complications during cardiac surgery still remain high. Bridgewater B et al. describes mortality during on-pump coronary artery bypass grafting (CABG) at 2%-3%, and the rate postoperative complications about 20%-30%. At the same time, the standard of care in patients undergoingon-pump CABG is not fully established.
Hypothesis, Research Need: Use of multimodal low-dose opioid anesthesia during CABG decreases inflammatory response and the incidence of early postoperative cardiac complications due to a reduction in interleukin-6.
Methodology: According to anesthesia standard protocol, all patients were divided into two groups - study group with multimodal low-dose opioid anesthesia (60 patients) and control group with a high-dose opioid anesthesia (60 patients). Primary (IL-6 at the end of the operation) and secondary clinical outcomes (postoperative atrial fibrillation (POAF), low cardiac output syndrome (LCOS), duration of mechanical ventilation (MV), length of intensive care unit (ICU) stay, length of hospital stay) were compared between the groups.
Analysis Tools: Clinical observations; instrumental research methods (electrocapdiography, echocardiography); labs (blood gases, hemoglobin, electrolytes); enzyme-linked immunosorbent assay (IL-6); statistical (Student's t-test, Mann-Whitney U test, χ2-test, correlation analysis).
Expected Outcomes: Use of multimodal low-dose opioid anesthesia during CABG will decrease inflammatory response (lower levels of IL-6 at the end of the surgery) and the incidence of early postoperative cardiac complications, expressed as lower incidence of LCOS and POAF, lower duration of MV and lower length of ICU stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First group | Experimental | Drug: Low opioid anesthesiaMultimodal low-opioid protocol provided for induction of anesthesia with intravenous (iv) propofol administration using the dosage of 1.5-2 mg/kg at 40 mg in interval of 10-15 seconds, iv fentanyl dosage 1-1.5 μg/kg and iv pipecuronium bromide dosage of 0.1 mg/kg. Before intubation of the trachea, a lidocaine 1 mg / kg bolus was added intravenously, with the simultaneous establishment of a continuous infusion at a dose of 1.5-2 mg/kg/h. All patients were administered a bolus of ketamine (0.5 mg/kg) and were started continuous infusion dexmedetomidine at a dose 0.7 μg/kg/h. If indicated fentanyl was used as additional analgesic during surgery by bolus injection. Depth of anesthesia was monitored with bispectral index; the dosage of sevoflurane from 1,5vol% to 2,5vol% was titrated to maintain BIS values from 40 to 60. |
| Second group | Active comparator | Drug: Low opioid anesthesiaRoutine opioid protocol of anesthesia provided for induction of anesthesia with the iv administration of propofol dosage of 1.5-2 mg/kg at 40 mg in interval of 15-20 seconds, iv fentanyl at a dose of 1-1.5 μg/kg and iv pipecuronium bromide dosage of 0.1 mg/kg. For analgesia, bolus injections of fentanyl were used at a dose of 8-10 μg/kg for the entire duration of the operation, muscle relaxation - pipecuronium bromide at a dose of 0.1 mg/kg. Depth of anesthesia was monitored with bispectral index; the dosage of sevoflurane from 1,5vol% to 2,5vol% was titrated to maintain BIS values from 40 to 60. |
Who may qualify
- Ages
- 44 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age from 44 to 65 years,
- nn ejection fraction > 30%,
- operational risk assessment for EuroSCORE II <5%,
- on-pump coronary artery bypass grafting
Key exclusion criteria (3 listed)
- patient's refusal
- off-pump coronary artery bypass grafting
- the need for additional intervention on the heart
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 |
|---|---|---|
| Low opioid anesthesiaMultimodal low-dose opioid protocol for anesthesia based on ketamine, lidocaine and dexmedetomidine | Drug | First group, Second group |
Primary outcome
Change of concentration of IL-6 in venous blood plasma immediately after the surgery
Time frame: immediately after surgery
Number of people with low cardiac output syndrome
Time frame: immediately after the surgery
Postoperative low cardiac output syndrome (LCOS) was defined as hemodynamic instability requiring continued pharmacologic support with 2 inotropic medications (epinephrine, milrinone, dobutamine) on postoperative day 1
Number of people with postoperative atrial fibrillation
Time frame: immediately after the surgery
Postoperative atrial fibrillation was defined as first appeared in the period immediately after surgery
Duration of mechanical ventilation
Time frame: immediately after the surgery
The decision about the extubation was made on the basis of following clinical criteria: recovering from muscle relaxation and anesthesia; patients is easy to rouse, neurologically intact, lift head and sticks out tongue; stable hemodynamics (heart rate and blood pressure are within ordered parameters, bleeding is controlled); spontaneous muscle movement with stable respiratory rate and adequate oxygenation, which was confirmed by arterial blood gases (SaO2 >92 %, on FiO2 <50%).
The length of ICU stay
Time frame: immediately after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2022.
- Derived from this study: PubMed 37803334Stepan M, Oleh L, Oleksandr D, Justyna S. Effects of multimodal low-opioid anesthesia protocol during on-pump coronary artery bypass grafting: a prospective cohort study. J Cardiothorac Surg. 2023 Oct 6;18(1):272. doi: 10.1186/s13019-023-02395-y.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low opioid anesthesia in people with Coronary Artery Disease and Low Cardiac Output Syndrome, run by Heart Institute, Ministry of Health of Ukraine at 1 site in Ukraine.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 24 Aug 2022. 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 Ukraine. 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?
Results are not available in the source record.
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 concentration of IL-6 in venous blood plasma immediately after the surgery (time frame: immediately after surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05514652, which also lists 1 linked publication.
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 24 Aug 2022.