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

NCT ID: NCT05451121

Last Updated: 2022-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 356 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2019-07-01

Brief Summary

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

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.

Conditions

Respiratory Failure; Mechanical Ventilation Complication; Sedation Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Propofol

Intervention Type: DRUG

patient sedation with a propofol (sedative agent) after cardiac surgery

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

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: DRUG

patient sedation with dexmedetomidine (selective α2-adrenergic receptor (α2-AR) agonist) after cardiac surgery

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

Group Type: EXPERIMENTAL

Propofol and dexmedetomidine

Intervention Type: DRUG

Patients sedation with a drug combination: propofol and dexmedetomidine (selective α2-adrenergic receptor (α2-AR) agonist)

Interventions

Propofol

patient sedation with a propofol (sedative agent) after cardiac surgery

Intervention Type: DRUG

Dexmedetomidine

patient sedation with dexmedetomidine (selective α2-adrenergic receptor (α2-AR) agonist) after cardiac surgery

Intervention Type: DRUG

Propofol and dexmedetomidine

Patients sedation with a drug combination: propofol and dexmedetomidine (selective α2-adrenergic receptor (α2-AR) agonist)

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anesthesia Research Group UA

OTHER

Sponsor Role: lead

Responsible Party

Plechysta Yelyzaveta

Chief of the anesthesia department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yelyzaveta Plechysta

Role: STUDY_CHAIR

Chief of the anesthesia department

Locations

Anesthesia department Medical Network Dobrobut

Kyiv, , Ukraine

Countries

Ukraine

Other Identifiers

0120U100656

Identifier Type: -

Identifier Source: org_study_id