Sedative Adverse ReactionNCT05451381
Vasopressor Requirements Depends on Sedation Strategy
A study testing Propofol, Dexmedetomidine and Dexmedetomidine and Propofol in people with Sedative Adverse Reaction and Sedation Complication, run by Anesthesia Research Group UA at 1 site in Ukraine.
Trial summary
Most of the patients after cardiac surgery need sedation in the iCU. Sedation strategy could impact the incidence of vasopressor use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sedative Adverse Reaction, Sedation Complication, Hemodynamic Instability
- 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 Aug 2017to 29 May 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 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;
- Patient consent to participate in the study;
- Women who have a negative pregnancy test and use effective contraception throughout the study and for 3 weeks after its completion, or women who are unable to have children (women who have undergone a hysterectomy (removal of the uterus) or tubal ligation, women with a clinical diagnosis of infertility) or are menopausal for more than 1 year (absence of menstruation for at least 12 months). Adequate methods of contraception include: surgical sterilization, double barrier method of contraception, local contraception;
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;
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- 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;
- Gastric or duodenal ulcer with risk of bleeding;
- 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: Vasopressor Requirements During Dexmedetomidine Sedation vs Propofol vs Their Combination (Dexmedetomidine and Propofol) Sedation in Patients After Cardiac Surgery
Most of the patients after cardiac surgery need sedation in the iCU. Sedation strategy could impact the incidence of vasopressor use.
Read the detailed description
Sedating a patient is a complex process, especially after heart surgery. Sedation has a negative hemodynamic effect. This leads to a decrease in blood pressure and increases the frequency and dose of vasopressors used. The choice of drug for sedation may have an impact on reducing the frequency of use of vasopressor therapy. The goal of the research is compare three strategies: propofol ( sedative agent), dexmedetomidine ( selective α2-adrenergic receptor (α2-AR) agonist that is associated with sedative effect) and their combination for sedation after cardiac surgery.
- Conditions
- Sedative Adverse Reaction, Sedation Complication, Hemodynamic Instability, Agitation on Recovery From Sedation, Respiratory Complication
- Being tested
- Propofol, Dexmedetomidine, Dexmedetomidine and Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Also called PR
sedation after cardiac surgery
DexmedetomidineDrug
Also called DEX
sedation after cardiac surgery
Dexmedetomidine and PropofolDrug
Also called DEX+PR
sedation after cardiac surgery
| Study group | Role | What they receive |
|---|---|---|
| Propofol group | Experimental | Patient sedation after cardiac surgery at the intensive care unit.
Sedation group (PR):
continuous infusion of propofol using a syringe pump at the dose of 1-1.5 mg / kg / h Receives: Drug: Propofol |
| Dexmedetomidine group | Experimental | Patient sedation after cardiac surgery at the intensive care unit.
Sedation group Dexmedetomidine (DEX):
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 group | 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.
vasopressor requirements
incidence of cases of using norepinephrine. measurement tool is a fact of using that is marked as yes\no in the check-list
Measured: every hour during sedation(up to 12 hours)
dose of norepinephrine
measure the maximum dose of norepinephrine in mcg\kg\min to achieve mean arterial pressure 70 mmHg
Measured: every hour during sedation (up to 12 hours)
Secondary outcomes (1)
Length of stay in the ICU
measure at days
Measured: before discharging from ICU to the ward ( up to 3 days)
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 Aug 2017
- Primary completion1 May 2022
- Study completion29 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedative Adverse ReactionStudies 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, Principal investigator, Chief of the anesthesia department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05451381
- Sponsor's protocol ID
- 0120U100657
- Status last verified
- Jul 2022
- First submitted
- 21 Jun 2022
- Last updated
- 12 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 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vasopressor Requirements During Dexmedetomidine Sedation vs Propofol vs Their Combination (Dexmedetomidine and Propofol) Sedation in Patients After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT05451381
- Acronym / sponsor ID
- 0120U100657
- Conditions
- Sedative Adverse Reaction, Sedation Complication, Hemodynamic Instability, Agitation on Recovery From Sedation, Respiratory Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 356 participants (actual)
- Lead sponsor
- Anesthesia Research Group UAUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 29 May 2022 (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.
Most of the patients after cardiac surgery need sedation in the iCU. Sedation strategy could impact the incidence of vasopressor use.
Detailed description
Sedating a patient is a complex process, especially after heart surgery. Sedation has a negative hemodynamic effect. This leads to a decrease in blood pressure and increases the frequency and dose of vasopressors used. The choice of drug for sedation may have an impact on reducing the frequency of use of vasopressor therapy. The goal of the research is compare three strategies: propofol ( sedative agent), dexmedetomidine ( selective α2-adrenergic receptor (α2-AR) agonist that is associated with sedative effect) and their combination for sedation 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. Sedation group (PR): continuous infusion of propofol using a syringe pump at the dose of 1-1.5 mg / kg / h |
| Dexmedetomidine group | Experimental | Drug: DexmedetomidinePatient sedation after cardiac surgery at the intensive care unit. Sedation group Dexmedetomidine (DEX): continuous infusion of Dexmedetomidine using a syringe pump at the dose of 0.5-1.0 mcg/ kg / h |
| Dexmedetomidine and propofol group | 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 (5 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;
- Patient consent to participate in the study;
- Women who have a negative pregnancy test and use effective contraception throughout the study and for 3 weeks after its completion, or women who are unable to have children (women who have undergone a hysterectomy (removal of the uterus) or tubal ligation, women with a clinical diagnosis of infertility) or are menopausal for more than 1 year (absence of menstruation for at least 12 months). Adequate methods of contraception include: surgical sterilization, double barrier method of contraception, local contraception;
Key exclusion criteria (21 listed)
- 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;
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: PRsedation after cardiac surgery | Drug | Propofol group |
| DexmedetomidineAlso: DEXsedation after cardiac surgery | Drug | Dexmedetomidine group |
| Dexmedetomidine and PropofolAlso: DEX+PRsedation after cardiac surgery | Drug | Dexmedetomidine and propofol group |
Primary outcome
vasopressor requirements
Time frame: every hour during sedation(up to 12 hours)
incidence of cases of using norepinephrine. measurement tool is a fact of using that is marked as yes\no in the check-list
dose of norepinephrine
Time frame: every hour during sedation (up to 12 hours)
measure the maximum dose of norepinephrine in mcg\kg\min to achieve mean arterial pressure 70 mmHg
1 secondary outcome
Length of stay in the ICU
Time frame: before discharging from ICU to the ward ( up to 3 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 12 Jul 2022.
- Individual participant dataSharing planned: No
Related trials for Sedative Adverse Reaction
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RecruitingPhase 4
Evaluation of Ketamine as Sedative Agent in Endoscopic Retrograde Cholangiopancreatography (ERCP)
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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, MD principal investigator
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 Sedative Adverse Reaction and Sedation 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 5 inclusion and 21 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 12 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?
vasopressor requirements (time frame: every hour during sedation(up to 12 hours)). The study lists 2 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 12 Jul 2022.