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

Primary Purpose

Respiratory Failure, Mechanical Ventilation Complication, Sedation Complication

Status

Completed

Phase

Not Applicable

Locations

Ukraine

Study Type

Interventional

Intervention

Propofol

Dexmedetomidine

Propofol and dexmedetomidine

About this trial

This is an interventional prevention trial for Respiratory Failure focused on measuring LOHS, sedation, cardiac surgery, intensive care unit

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Anesthesia department Medical Network Dobrobut

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

propofol

Dexmedetomidine

propofol and dexmedetomidine

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

length of the mechanical ventilation

measure the length of the mechanical ventilation

Secondary Outcome Measures

Length of the ICU stay

thе amount of the days spent in the ICU

Length of the hospital stay

thе amount of the days spent in the hospital

Full Information

NCT ID

NCT05451121

First Posted

June 30, 2022

Last Updated

July 5, 2022

Sponsor

Anesthesia Research Group UA

1. Study Identification

Unique Protocol Identification Number

NCT05451121

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Completed

Study Start Date

July 1, 2017 (Actual)

Primary Completion Date

July 1, 2019 (Actual)

Study Completion Date

July 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Anesthesia Research Group UA

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Respiratory Failure, Mechanical Ventilation Complication, Sedation Complication

Keywords

LOHS, sedation, cardiac surgery, intensive care unit

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

356 (Actual)

8. Arms, Groups, and Interventions

Arm Title

propofol

Arm Type

Experimental

Arm Description

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

Arm Title

Dexmedetomidine

Arm Type

Experimental

Arm Description

Arm Title

propofol and dexmedetomidine

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Propofol

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Dexmedetomidine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Propofol and dexmedetomidine

Intervention Description

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

Primary Outcome Measure Information:

Title

length of the mechanical ventilation

Description

measure the length of the mechanical ventilation

Time Frame

after cardiac surgery till extubation (up to first 24 hour after surgery)

Secondary Outcome Measure Information:

Title

Length of the ICU stay

Description

thе amount of the days spent in the ICU

Time Frame

at the day of discharge of ICU (assessed up to day 5)

Title

Length of the hospital stay

Description

thе amount of the days spent in the hospital

Time Frame

at the day of discharge of hospital (assessed up to day 5)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yelyzaveta Plechysta

Organizational Affiliation

Chief of the anesthesia department

Official's Role

Study Chair

Facility Information:

Facility Name

Anesthesia department Medical Network Dobrobut

City

Kyiv

ZIP/Postal Code

01000

Country

Ukraine

12. IPD Sharing Statement

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

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