Influence of Sedation Strategies on Hospital LOS and ICU LOS in Patients Cardiac Surgery (LOS)

Influence of Sedation Strategies on Hospital LOS and ICU LOS in Patients After Cardiac Surgery With Cardiac Pulmonary Bypass. Comparison of Propofol-based, Dexmedetomidine-based Sedation or Their Combination.

Preoperative, intraoperative and postoperative management of the patient are some of the main stages that can affect the hospital LOS and ICU LOS. Experience on the evidence-based approach and the progressive guidelines implementation of recommendations, the issue of the choice of drugs for sedation in the family and their impact on the length of stay in the intensive care unit and the length of hospitalization remain unsolved.

Study Overview

• Status: Completed
• Conditions: Sedation Complication
• Intervention / Treatment: Drug: Dexmedetomidine and Propofol; Drug: Propofol injection; Drug: Dexmedetomidine injection

Detailed Description

Optimization of sedation regimes can become one of the factors that will help to reduce the length of hospital and ICU stay. The purpose of the study is to track is there a relationship between the drug for sedation and the length of stay of patients in the intensive care unit and in hospital treatment.

• Study Type: Interventional
• Enrollment (Actual): 194
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Multi vascular lesions of the coronary arteries according to coronary angiography;
• Heart valve damage was confirmed by heart ultrasound, 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)
• Patient consent to participate in the study;
• Women who have a negative pregnancy test and use effective contraception throughout the study and for 3 weeks after its completion, or women who are unable to have children (women who have undergone a hysterectomy (removal of the uterus) or tubal ligation, women with a clinical diagnosis of infertility) or are menopausal for more than 1 year (absence of menstruation for at least 12 months). Adequate methods of contraception include: surgical sterilization, double barrier method of contraception, local contraception;

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;
• Gastric or duodenal ulcer with risk of bleeding;
• 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 Group; Patient sedation after cardiac surgery at the intensive care unit. Sedation group (Pr): continuous infusion of propofol using a syringe pump at the dose of 1-1.5 mg / kg / h	Drug: Propofol injection; sedation after cardiac surgery; Other Names: Pr
Experimental: Dexmedetomidine group; Patient sedation after cardiac surgery at the intensive care unit. Sedation group Dexmedetomidine (Dx): continuous infusion of Dexmedetomidine using a syringe pump at the dose of 0.5-1.0 mcg/ kg / h	Drug: Dexmedetomidine injection; sedation after cardiac surgery; Other Names: Dx
Experimental: Dexmedetomidine and propofol group; Patient sedation after cardiac surgery at the intensive care unit. Sedation group DxPr: 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: Dexmedetomidine and Propofol; sedation after cardiac surgery; Other Names: DxPr

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hospital LOS	measure at days	from admission to discharge ( up to 20 days)
ICU LOS	measure at days	before discharging from ICU to the ward ( up to 7 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
difference in ICU LOS in patients with vasopressors and without vasopressors	measure at days	before discharging from ICU to the ward ( up to 7 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
difference in hospital LOS in patients with vasopressors and without vasopressors	measure at days	from admission to discharge ( up to 20 days)

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): February 15, 2018
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: March 30, 2023
• First Submitted That Met QC Criteria: March 30, 2023
• First Posted (Actual): April 12, 2023

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: March 30, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: cardiac surgery; ICU LOS; vasopressors; postoperative sedation; ICU sedation; hospital LOS
• Additional Relevant MeSH Terms: 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: 5-08-039.35

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No