ArrythmiaNCT05450497
Effect of Sedative Agent on Reducing the Frequency of Arrhythmia in the Patients After Cardiac Surgery
A study testing Propofol, Dexmedetomidine and Dexmedetomidine and propofol in people with Arrythmia, run by Anesthesia Research Group UA at 1 site in Ukraine.
Trial summary
Arrhythmias early in the recovery period after cardio thoracic surgery are common they develop in 11 to 40 percent of patients after coronary-artery bypass grafting. The right chose of sedative agent could decrease the level of arrhythmia incidence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrythmia
- What is being tested?
- Propofol, Dexmedetomidine and Dexmedetomidine and propofol
- 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 heart ultrasound, 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;
Who cannot join
- Refusal to participate;
- Hypersensitivity to propofol, dexmedetomidine;
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Propofol vs Dexmedetomidine or Propofol+Dexmedetomidine on Reducing the Frequency of Arrhythmia in Patients After Cardiac Surgery
Arrhythmias early in the recovery period after cardio thoracic surgery are common they develop in 11 to 40 percent of patients after coronary-artery bypass grafting. The right chose of sedative agent could decrease the level of arrhythmia incidence.
Read the detailed description
Arrhythmias are really common in patients after cardiac surgery. Most of the patients get sedation after cardiac surgery. The goal is to determine if the propofol (PR) (sedative agent), dexmedetomidine (DEX)(selective α2-adrenergic receptor (α2-AR) agonist) or their combination could improve and decrease the incidence of the arrhythmia in patients after cardiac surgery.
- Conditions
- Arrythmia
- Being tested
- Propofol, Dexmedetomidine, Dexmedetomidine and propofol
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
comparing sedative agents
DexmedetomidineDrug
comparing sedative agents
Dexmedetomidine and propofolDrug
comparing sedative agents
| Study group | Role | What they receive |
|---|---|---|
| Propofol Group | Experimental | Patient sedation after cardiac surgery at the intensive care unit. Continuous infusion of propofol 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 using a syringe pump at the dose of 0.5-1.0 mcg/ kg / h Receives: Drug: Dexmedetomidine |
| Dexmedetomidine and propofol | Experimental | Patient sedation after cardiac surgery at the intensive care unit.
Sedation group DEX+PR:
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: Dexmedetomidine and propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of arrhythmia
incidence of deviation from the rhythm before the surgery and at the day of the discharge from the hospital after cardia surgery
Measured: day of the discharge from the 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 posted8 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 ArrythmiaStudies 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, MD, Study chair, Chief of the anesthesia department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05450497
- Sponsor's protocol ID
- 0120U100655
- Status last verified
- Jul 2022
- First submitted
- 30 Jun 2022
- Last updated
- 8 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Propofol vs Dexmedetomidine or Propofol+Dexmedetomidine on Reducing the Frequency of Arrhythmia in Patients After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT05450497
- Acronym / sponsor ID
- 0120U100655
- Conditions
- Arrythmia
- 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
- 8 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.
Arrhythmias early in the recovery period after cardio thoracic surgery are common they develop in 11 to 40 percent of patients after coronary-artery bypass grafting. The right chose of sedative agent could decrease the level of arrhythmia incidence.
Detailed description
Arrhythmias are really common in patients after cardiac surgery. Most of the patients get sedation after cardiac surgery. The goal is to determine if the propofol (PR) (sedative agent), dexmedetomidine (DEX)(selective α2-adrenergic receptor (α2-AR) agonist) or their combination could improve and decrease the incidence of the arrhythmia in patients after cardiac surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Propofol Group | Experimental | Drug: PropofolPatient sedation after cardiac surgery at the intensive care unit. Continuous infusion of propofol 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 using a syringe pump at the dose of 0.5-1.0 mcg/ kg / h |
| Dexmedetomidine and propofol | Experimental | Drug: Dexmedetomidine and propofolPatient sedation after cardiac surgery at the intensive care unit. Sedation group DEX+PR: 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 heart ultrasound, 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;
Key exclusion criteria (3 listed)
- Refusal to participate;
- Hypersensitivity to propofol, dexmedetomidine;
- 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)
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 |
|---|---|---|
| Propofolcomparing sedative agents | Drug | Propofol Group |
| Dexmedetomidinecomparing sedative agents | Drug | Dexmedetomidine |
| Dexmedetomidine and propofolcomparing sedative agents | Drug | Dexmedetomidine and propofol |
Primary outcome
incidence of arrhythmia
Time frame: day of the discharge from the hospital (assessed up to day 5)
incidence of deviation from the rhythm before the surgery and at the day of the discharge from the hospital after cardia surgery
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 8 Jul 2022.
- Individual participant dataSharing planned: No
Related trials for Arrythmia
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Enrolling by invitation
EDEN Intracardiac Electrogram Recording and Classifying System
Ventricular Arrhythmia
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, MD 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 Dexmedetomidine and propofol in people with Arrythmia, 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 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: finished, as of the sponsor's last update on 8 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?
incidence of arrhythmia (time frame: day of the discharge from the hospital (assessed up to day 5)). 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 8 Jul 2022.