Effect of Sedative Agent on Reducing the Frequency of Arrhythmia in the Patients After Cardiac Surgery

NCT05450497 | Completed

• 1 other identifier: 0120U100655
• Study Type: interventional
• Target: 356
• Locations: 1 country
• Sites: 1

Brief Summary

Arrhythmias early in the recovery period after cardio thoracic surgery are common they develop in 11 to 40 percent of patients after coronary-artery bypass grafting. The right chose of sedative agent could decrease the level of arrhythmia incidence.

Conditions

Arrythmia

Outcome Measures

Primary Outcomes (1)

• incidence of arrhythmia

  incidence of deviation from the rhythm before the surgery and at the day of the discharge from the hospital after cardia surgery

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

Study Arms (3)

Propofol Group

EXPERIMENTAL

Patient sedation after cardiac surgery at the intensive care unit. Continuous infusion of propofol 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 using a syringe pump at the dose of 0.5-1.0 mcg/ kg / h

Drug: Dexmedetomidine

Dexmedetomidine and propofol

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

comparing sedative agents

Propofol Group

Dexmedetomidine DRUG

comparing sedative agents

Dexmedetomidine

Dexmedetomidine and propofol DRUG

comparing sedative agents

Dexmedetomidine and propofol

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;

You may not qualify if:

• Refusal to participate;
• Hypersensitivity to propofol, dexmedetomidine;
• 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

Conditions

Arrhythmias, Cardiac

Interventions

Propofol; Dexmedetomidine

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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

  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 8, 2022
• Study Start: July 1, 2017
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: July 8, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

UA (1)