Vasopressor Requirements Depends on Sedation Strategy

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Complication; Hemodynamic Instability; Sedation Complication; Agitation on Recovery From Sedation; Sedative Adverse Reaction
• Intervention / Treatment: Drug: Propofol; Drug: Dexmedetomidine; Drug: Dexmedetomidine and Propofol

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 Type: Interventional
• Enrollment (Actual): 356
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ukraine
  • Kyiv, Ukraine, 01000
    • Cardiosurgery departments with intensive care block

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Propofol group; 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; sedation after cardiac surgery; Other Names: PR
Experimental: Dexmedetomidine group; 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; sedation after cardiac surgery; Other Names: DEX
Experimental: Dexmedetomidine and propofol group; 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; Other Names: DEX+PR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay in the ICU	measure at days	before discharging from ICU to the ward ( up to 3 days)

Collaborators and Investigators

• Sponsor: Anesthesia Research Group UA
• Investigators: Principal Investigator: Yelyzaveta Plechysta, MD, chief of the anesthesia department

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): May 1, 2022
• Study Completion (Actual): May 29, 2022

Study Registration Dates

• First Submitted: June 21, 2022
• First Submitted That Met QC Criteria: July 5, 2022
• First Posted (Actual): July 11, 2022

Study Record Updates

• Last Update Posted (Actual): July 12, 2022
• Last Update Submitted That Met QC Criteria: July 8, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Dyskinesias; Psychomotor Disorders; Psychomotor Agitation; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Propofol; Dexmedetomidine
• Other Study ID Numbers: 0120U100657

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No