Effect of Sedation Strategy on Duration Mechanical Ventilation in Patient After Cardiac Surgery

Comparing Effect of Propofol, Dexmedetomidine and Their Combination on Duration Mechanical Ventilation in Patient After Cardiac Surgery

There is a direct relationship between the sedative agent and the duration of ventilation.

Study Overview

• Status: Completed
• Conditions: Respiratory Failure; Mechanical Ventilation Complication; Sedation Complication
• Intervention / Treatment: Drug: Propofol; Drug: Dexmedetomidine; Drug: Propofol and dexmedetomidine

Detailed Description

Sedation and sedative agent have direct correlation to the mechanical length. As known mechanical length could increase length of the hospital stay (LOHS) and mortality rate. The right sedative agent can decrease the length go the mechanical ventilation. The goal of the research to compare 3 sedation strategies and their influence to the duration of mechanical ventilation.

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

Contacts and Locations

Study Locations

• Ukraine
  • Kyiv, Ukraine, 01000
    • Anesthesia department Medical Network Dobrobut

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, 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;

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;
  • 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; Patient sedation after cardiac surgery at the intensive care unit. Continuous infusion of propofol (hypnotic agent) using a syringe pump at the dose of 1-1.5 mg / kg / h	Drug: Propofol; patient sedation with a propofol (sedative agent) after cardiac surgery
Experimental: Dexmedetomidine; Patient sedation after cardiac surgery at the intensive care unit. continuous infusion of Dexmedetomidine (selective α2-adrenergic receptor (α2-AR) agonist) using a syringe pump at the dose of 0.5-1.0 mcg/ kg / h	Drug: Dexmedetomidine; patient sedation with dexmedetomidine (selective α2-adrenergic receptor (α2-AR) agonist) after cardiac surgery
Experimental: propofol and dexmedetomidine; Patient sedation after cardiac surgery at the intensive care unit. 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: Propofol and dexmedetomidine; Patients sedation with a drug combination: propofol and dexmedetomidine (selective α2-adrenergic receptor (α2-AR) agonist)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
length of the mechanical ventilation	measure the length of the mechanical ventilation	after cardiac surgery till extubation (up to first 24 hour after surgery)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of the ICU stay	thе amount of the days spent in the ICU	at the day of discharge of ICU (assessed up to day 5)
Length of the hospital stay	thе amount of the days spent in the hospital	at the day of discharge of hospital (assessed up to day 5)

Collaborators and Investigators

• Sponsor: Anesthesia Research Group UA
• Investigators: Study Chair: Yelyzaveta Plechysta, chief of the anesthesia department

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): July 1, 2019
• Study Completion (Actual): July 1, 2019

Study Registration Dates

• First Submitted: June 30, 2022
• First Submitted That Met QC Criteria: July 5, 2022
• First Posted (Actual): July 11, 2022

Study Record Updates

• Last Update Posted (Actual): July 11, 2022
• Last Update Submitted That Met QC Criteria: July 5, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: LOHS, sedation, cardiac surgery, intensive care unit
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency; 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: 0120U100656

Drug and device information, study documents

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