Vasopressor Requirements Depends on Sedation Strategy

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05451381
• Other study ID #: 0120U100657
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: May 29, 2022

Study information

• Verified date: July 2022
• Source: Anesthesia Research Group UA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Most of the patients after cardiac surgery need sedation in the iCU. Sedation strategy could impact the incidence of vasopressor use.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Agitation on Recovery From Sedation
• Hemodynamic Instability
• Psychomotor Agitation
• Respiratory Complication
• Sedation Complication
• Sedative Adverse Reaction

Intervention

Drug:
• Propofol
sedation after cardiac surgery
• Dexmedetomidine
sedation after cardiac surgery
• Dexmedetomidine and Propofol
sedation after cardiac surgery

Locations

Country	Name	City	State
Ukraine	Cardiosurgery departments with intensive care block	Kyiv

Sponsors (1)

Lead Sponsor	Collaborator
Anesthesia Research Group UA

Country where clinical trial is conducted

Ukraine, 

Outcome

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)