Vasopressor Requirements Depends on Sedation Strategy

NCT05451381 | Completed

• 1 other identifier: 0120U100657
• Study Type: interventional
• Target: 356
• Locations: 1 country
• Sites: 1

Brief Summary

Most of the patients after cardiac surgery need sedation in the iCU. Sedation strategy could impact the incidence of vasopressor use.

Conditions

Sedative Adverse Reaction; Sedation Complication; Hemodynamic Instability; Agitation on Recovery From Sedation; Respiratory Complication

Outcome Measures

Primary Outcomes (2)

• vasopressor requirements

  incidence of cases of using norepinephrine. measurement tool is a fact of using that is marked as yes\\no in the check-list

  every hour during sedation(up to 12 hours)

• dose of norepinephrine

  measure the maximum dose of norepinephrine in mcg\\kg\\min to achieve mean arterial pressure 70 mmHg

  every hour during sedation (up to 12 hours)

Secondary Outcomes (1)

• Length of stay in the ICU

  before discharging from ICU to the ward ( up to 3 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

Dexmedetomidine group

EXPERIMENTAL

Patient sedation after cardiac surgery at the intensive care unit. Sedation group Dexmedetomidine (DEX): continuous infusion of Dexmedetomidine using a syringe pump at the dose of 0.5-1.0 mcg/ kg / h

Drug: Dexmedetomidine

Dexmedetomidine and propofol group

EXPERIMENTAL

Patient sedation after cardiac surgery at the intensive care unit. Sedation group DEX+PR: 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 DRUG

sedation after cardiac surgery

Also known as: PR

Propofol group

Dexmedetomidine DRUG

sedation after cardiac surgery

Also known as: DEX

Dexmedetomidine group

Dexmedetomidine and Propofol DRUG

sedation after cardiac surgery

Also known as: DEX+PR

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)
• Age of patients from 18-80 years;
• 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)

Cardiosurgery departments with intensive care block

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, MD

  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: June 21, 2022
• First Posted: July 11, 2022
• Study Start: August 1, 2017
• Primary Completion: May 1, 2022
• Study Completion: May 29, 2022
• Last Updated: July 12, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

UA (1)