An interventional study of Propofol and Dexmedetomidine in Sedative Adverse Reaction, Sedation Complication and Hemodynamic Instability, sponsored by Anesthesia Research Group UA. Completed at 1 site in Ukraine. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-12.
Sponsored by Anesthesia Research Group UA · Not applicable, Interventional, and Prevention
Most of the patients after cardiac surgery need sedation in the iCU. Sedation strategy could impact the incidence of vasopressor use.
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.
500 studies on the registry are indexed under Psychomotor Agitation; 55 are open to participants now.
This study's enrollment of 356 is above the median of 90 across 413 interventional studies indexed under Psychomotor Agitation.
Browse Psychomotor Agitation studies →Anesthesia Research Group UA is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
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
Drug: Propofol
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
Drug: Dexmedetomidine
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
Drug: Dexmedetomidine and Propofol
sedation after cardiac surgery
Also known as: PR
sedation after cardiac surgery
Also known as: DEX
sedation after cardiac surgery
Also known as: DEX+PR
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
Time frame: 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
Time frame: every hour during sedation (up to 12 hours)
Length of stay in the ICU
measure at days
Time frame: before discharging from ICU to the ward ( up to 3 days)
Plan to share: No
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This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Anesthesia Research Group UA