Vasopressor Requirements Depends on Sedation Strategy

Not Applicable

Completed

• Conditions: Sedative Adverse Reaction; Sedation Complication; Hemodynamic Instability; Agitation on Recovery From Sedation; Respiratory Complication
• Interventions: Drug: Dexmedetomidine and Propofol; Drug: Propofol; Drug: Dexmedetomidine

• Registration Number: NCT05451381
• Lead Sponsor: Anesthesia Research Group UA

Brief Summary

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 Timeline

• Study Start: 2017-08-01
• Primary Completion: 2022-05-01
• Study Completion: 2022-05-29
• Study First Submitted: 2022-06-21
• Status Verified: 2022-07
• Study First Submitted QC: 2022-07-05
• Last Update Submitted: 2022-07-08
• Study First Posted: 2022-07-11
• Last Update Posted: 2022-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 356

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine and propofol group	Dexmedetomidine and Propofol	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
Propofol group	Propofol	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
Dexmedetomidine group	Dexmedetomidine	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

Primary Outcome Measures

Name	Time	Method
vasopressor requirements	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	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

Secondary Outcome Measures

Name	Time	Method
Length of stay in the ICU	before discharging from ICU to the ward ( up to 3 days)	measure at days

Trial Locations

Locations (1)

Cardiosurgery departments with intensive care block; 🇺🇦 Kyiv, Ukraine