Hemodynamic Instability Clinical Trial
Official title:
Vasopressor Requirements During Dexmedetomidine Sedation vs Propofol vs Their Combination (Dexmedetomidine and Propofol) Sedation in Patients After Cardiac Surgery
NCT number | NCT05451381 |
Other study ID # | 0120U100657 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 1, 2017 |
Est. completion date | May 29, 2022 |
Verified date | July 2022 |
Source | Anesthesia Research Group UA |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Most of the patients after cardiac surgery need sedation in the iCU. Sedation strategy could impact the incidence of vasopressor use.
Status | Completed |
Enrollment | 356 |
Est. completion date | May 29, 2022 |
Est. primary completion date | May 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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; Exclusion Criteria: - 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; - 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. |
Country | Name | City | State |
---|---|---|---|
Ukraine | Cardiosurgery departments with intensive care block | Kyiv |
Lead Sponsor | Collaborator |
---|---|
Anesthesia Research Group UA |
Ukraine,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | every hour during sedation(up to 12 hours) | |
Primary | dose of norepinephrine | measure the maximum dose of norepinephrine in mcg\kg\min to achieve mean arterial pressure 70 mmHg | every hour during sedation (up to 12 hours) | |
Secondary | Length of stay in the ICU | measure at days | before discharging from ICU to the ward ( up to 3 days) |
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