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

NCT05809518 | Completed

• 1 other identifier: 5-08-039.35
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sedation Complication

Keywords

cardiac surgery; ICU sedation; hospital LOS; ICU LOS; vasopressors; postoperative sedation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• difference in ICU LOS in patients with vasopressors and without vasopressors

  before discharging from ICU to the ward ( up to 7 days

Other Outcomes (1)

• difference in hospital LOS in patients with vasopressors and without vasopressors

  from admission to discharge ( up to 20 days)

Study Arms (3)

Propofol Group

EXPERIMENTAL

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

Dexmedetomidine group

EXPERIMENTAL

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

Dexmedetomidine and propofol group

EXPERIMENTAL

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

Interventions

Propofol injection DRUG

sedation after cardiac surgery

Also known as: Pr

Propofol Group

Dexmedetomidine injection DRUG

sedation after cardiac surgery

Also known as: Dx

Dexmedetomidine group

Dexmedetomidine and Propofol DRUG

sedation after cardiac surgery

Also known as: DxPr

Dexmedetomidine and propofol group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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 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;

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;
• 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)

Sponsors & Collaborators

• Anesthesia Research Group UA: lead

Study Sites (1)

Medical Network Dobrobut

Kyiv, 01000, Ukraine

Location

MeSH Terms

Interventions

Propofol; Dexmedetomidine

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Yelyzaveta Plechysta

  Chief of the anesthesia department

  PRINCIPAL INVESTIGATOR

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: March 30, 2023
• First Posted: April 12, 2023
• Study Start: January 1, 2017
• Primary Completion: February 15, 2018
• Study Completion: December 31, 2019
• Last Updated: April 12, 2023

Record last verified: 2023-03

Locations

UA (1)