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

Not Applicable

Completed

• Conditions: Mechanical Ventilation Complication; Respiratory Failure; Sedation Complication
• Interventions: Drug: Propofol and dexmedetomidine; Drug: Dexmedetomidine; Drug: Propofol

• Registration Number: NCT05451121
• Lead Sponsor: Anesthesia Research Group UA

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.

Study Timeline

• Study Start: 2017-07-01
• Primary Completion: 2019-07-01
• Study Completion: 2019-07-01
• Study First Submitted: 2022-06-30
• Status Verified: 2022-07
• Study First Submitted QC: 2022-07-05
• Last Update Submitted: 2022-07-05
• Study First Posted: 2022-07-11
• Last Update Posted: 2022-07-11

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, 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
propofol and dexmedetomidine	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
Dexmedetomidine	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
propofol	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

Primary Outcome Measures

Name	Time	Method
length of the mechanical ventilation	after cardiac surgery till extubation (up to first 24 hour after surgery)	measure the length of the mechanical ventilation

Secondary Outcome Measures

Name	Time	Method
Length of the ICU stay	at the day of discharge of ICU (assessed up to day 5)	thе amount of the days spent in the ICU
Length of the hospital stay	at the day of discharge of hospital (assessed up to day 5)	thе amount of the days spent in the hospital

Trial Locations

Locations (1)

Anesthesia department Medical Network Dobrobut; 🇺🇦 Kyiv, Ukraine