Respiratory FailureNCT05451121
Effect of Sedation Strategy on Duration Mechanical Ventilation in Patient After Cardiac Surgery
A study testing Propofol, Dexmedetomidine and Propofol and dexmedetomidine in people with Respiratory Failure and Mechanical Ventilation Complication, run by Anesthesia Research Group UA at 1 site in Ukraine.
Trial summary
There is a direct relationship between the sedative agent and the duration of ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure, Mechanical Ventilation Complication, Sedation Complication
- What is being tested?
- Propofol, Dexmedetomidine and Propofol and dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 356 participants
- Where
- 1 siteUkraine
- Study dates
- 1 Jul 2017to 1 Jul 2019
- 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
- Multi vascular lesions of the coronary arteries according to coronary angiography;
- Heart valve damage was confirmed by, which is subject to surgical correction (aortic stenosis of III degree with a gradient on the aortic valve of more than 42 mmHg, aortic insufficiency III, mitral valve stenosis II-III, mitral regurgitation II-III)
- Age of patients from 18-80 years; • Patient consent to participate in the study;
Who cannot join
- Refusal to participate;
- Hypersensitivity to propofol, dexmedetomidine;
- Prolonged mechanical ventilation in case of surgical complications (bleeding, inadequate perfusion of the myocardium);
- Occurred ischemic stroke;
- History of the ischemic stroke;
- History of the neurodegenerative diseases;
Show all 20Show fewer
- History of the mental disorders;
- Use of neuroleptics, antidepressants for the last 5 years;
- History of the cardiac surgery in the past;
- Patients with chronic pulmonary disease (GOLD 3-4)
- Patients with asthma (moderate or severe),
- Participation in any other clinical trial;
- Chronic renal failure (ClCr less than 50 ml / h)
- Acute renal failure that occurred during surgery (ClCr less than 50 ml / h, or a decrease in the rate of diuresis to 0.1 ml / h in the first 4 hours after surgery and does not respond to diuretic therapy)
- Chronic hepatic insufficiency if there are laboratory signs of hypo coagulation without the use of anticoagulant therapy (INR> 1.5)
- If the patient has not stopped taking anticoagulants or antiplatelet agents in the preoperative period: warfarin 5 days before surgery, clopidogrel 5-7 days before surgery, xarelto / pradaxa 3 days before surgery),
- History of the hematological disease;
- Alcohol abuse in the anamnesis (3-4 times a week).
- Condition after chemotherapy;
- Pregnancy, lactation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing Effect of Propofol, Dexmedetomidine and Their Combination on Duration Mechanical Ventilation in Patient After Cardiac Surgery
There is a direct relationship between the sedative agent and the duration of ventilation.
Read the detailed description
Sedation and sedative agent have direct correlation to the mechanical length. As known mechanical length could increase length of the hospital stay (LOHS) and mortality rate. The right sedative agent can decrease the length go the mechanical ventilation. The goal of the research to compare 3 sedation strategies and their influence to the duration of mechanical ventilation.
- Being tested
- Propofol, Dexmedetomidine, Propofol and dexmedetomidine
- Keywords
- LOHS, sedation, cardiac surgery, intensive care unit
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
patient sedation with a propofol (sedative agent) after cardiac surgery
DexmedetomidineDrug
patient sedation with dexmedetomidine (selective α2-adrenergic receptor (α2-AR) agonist) after cardiac surgery
Propofol and dexmedetomidineDrug
Patients sedation with a drug combination: propofol and dexmedetomidine (selective α2-adrenergic receptor (α2-AR) agonist)
| Study group | Role | What they receive |
|---|---|---|
| propofol | Experimental | Patient sedation after cardiac surgery at the intensive care unit. Continuous infusion of propofol (hypnotic agent) using a syringe pump at the dose of 1-1.5 mg / kg / h Receives: Drug: Propofol |
| Dexmedetomidine | Experimental | Patient sedation after cardiac surgery at the intensive care unit. continuous infusion of Dexmedetomidine (selective α2-adrenergic receptor (α2-AR) agonist) using a syringe pump at the dose of 0.5-1.0 mcg/ kg / h Receives: Drug: Dexmedetomidine |
| propofol and dexmedetomidine | Experimental | Patient sedation after cardiac surgery at the intensive care unit. Continuous infusion of propofol using a syringe pump at the dose of 0.5-1.5 mg / kg / h and dexmedetomidine 0.2-0.7 mcg\kg\h Receives: Drug: Propofol and dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
length of the mechanical ventilation
measure the length of the mechanical ventilation
Measured: after cardiac surgery till extubation (up to first 24 hour after surgery)
Secondary outcomes (2)
Length of the ICU stay
thе amount of the days spent in the ICU
Measured: at the day of discharge of ICU (assessed up to day 5)
Length of the hospital stay
thе amount of the days spent in the hospital
Measured: at the day of discharge of hospital (assessed up to day 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start1 Jul 2017
- Primary completion1 Jul 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 356 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anesthesia Research Group UA
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Plechysta Yelyzaveta, Anesthesia Research Group UA
- Investigators
- Yelyzaveta Plechysta, Study chair, Chief of the anesthesia department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05451121
- Sponsor's protocol ID
- 0120U100656
- Status last verified
- Jul 2022
- First submitted
- 30 Jun 2022
- Last updated
- 11 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Effect of Propofol, Dexmedetomidine and Their Combination on Duration Mechanical Ventilation in Patient After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT05451121
- Acronym / sponsor ID
- 0120U100656
- Keywords
- LOHS, sedation, cardiac surgery, intensive care unit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 356 participants (actual)
- Lead sponsor
- Anesthesia Research Group UAUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 11 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.
There is a direct relationship between the sedative agent and the duration of ventilation.
Detailed description
Sedation and sedative agent have direct correlation to the mechanical length. As known mechanical length could increase length of the hospital stay (LOHS) and mortality rate. The right sedative agent can decrease the length go the mechanical ventilation. The goal of the research to compare 3 sedation strategies and their influence to the duration of mechanical ventilation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| propofol | Experimental | Drug: PropofolPatient sedation after cardiac surgery at the intensive care unit. Continuous infusion of propofol (hypnotic agent) using a syringe pump at the dose of 1-1.5 mg / kg / h |
| Dexmedetomidine | Experimental | Drug: DexmedetomidinePatient sedation after cardiac surgery at the intensive care unit. continuous infusion of Dexmedetomidine (selective α2-adrenergic receptor (α2-AR) agonist) using a syringe pump at the dose of 0.5-1.0 mcg/ kg / h |
| propofol and dexmedetomidine | Experimental | Drug: Propofol and dexmedetomidinePatient sedation after cardiac surgery at the intensive care unit. Continuous infusion of propofol using a syringe pump at the dose of 0.5-1.5 mg / kg / h and dexmedetomidine 0.2-0.7 mcg\kg\h |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Multi vascular lesions of the coronary arteries according to coronary angiography;
- Heart valve damage was confirmed by, which is subject to surgical correction (aortic stenosis of III degree with a gradient on the aortic valve of more than 42 mmHg, aortic insufficiency III, mitral valve stenosis II-III, mitral regurgitation II-III)
- Age of patients from 18-80 years; • Patient consent to participate in the study;
Key exclusion criteria (20 listed)
- Refusal to participate;
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 |
|---|---|---|
| Propofolpatient sedation with a propofol (sedative agent) after cardiac surgery | Drug | propofol |
| Dexmedetomidinepatient sedation with dexmedetomidine (selective α2-adrenergic receptor (α2-AR) agonist) after cardiac surgery | Drug | Dexmedetomidine |
| Propofol and dexmedetomidinePatients sedation with a drug combination: propofol and dexmedetomidine (selective α2-adrenergic receptor (α2-AR) agonist) | Drug | propofol and dexmedetomidine |
Primary outcome
length of the mechanical ventilation
Time frame: after cardiac surgery till extubation (up to first 24 hour after surgery)
measure the length of the mechanical ventilation
2 secondary outcomes
Length of the ICU stay
Time frame: at the day of discharge of ICU (assessed up to day 5)
Length of the hospital stay
Time frame: at the day of discharge of hospital (assessed up to day 5)
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 11 Jul 2022.
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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.
Yelyzaveta Plechysta study chair
Chief of the anesthesia department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol, Dexmedetomidine and Propofol and dexmedetomidine in people with Respiratory Failure and Mechanical Ventilation Complication, run by Anesthesia Research Group UA 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 3 inclusion and 20 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 11 Jul 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?
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?
length of the mechanical ventilation (time frame: after cardiac surgery till extubation (up to first 24 hour after surgery)). 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 11 Jul 2022.