NCT05451121

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
356

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

June 30, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 11, 2022

Completed
Last Updated

July 11, 2022

Status Verified

July 1, 2022

Enrollment Period

2 years

First QC Date

June 30, 2022

Last Update Submit

July 5, 2022

Conditions

Respiratory FailureMechanical Ventilation ComplicationSedation Complication

Keywords

LOHS, sedation, cardiac surgery, intensive care unit

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Length of the ICU stay

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

  • Length of the hospital stay

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

Study Arms (3)

propofol

EXPERIMENTAL

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

Dexmedetomidine

EXPERIMENTAL

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

propofol and dexmedetomidine

EXPERIMENTAL

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

Interventions

PropofolDRUG

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

propofol
DexmedetomidineDRUG

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

Dexmedetomidine
Propofol and dexmedetomidineDRUG

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

propofol and dexmedetomidine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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)
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anesthesia department Medical Network Dobrobut

Kyiv, 01000, Ukraine

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

PropofolDexmedetomidine

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Yelyzaveta Plechysta

    Chief of the anesthesia department

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of the anesthesia department

Study Record Dates

First Submitted

June 30, 2022

First Posted

July 11, 2022

Study Start

July 1, 2017

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

July 11, 2022

Record last verified: 2022-07

Locations

UA(1)