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

Arrythmia Clinical Trial

Official title:

Effect of Propofol vs Dexmedetomidine or Propofol+Dexmedetomidine on Reducing the Frequency of Arrhythmia in Patients After Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05450497
• Other study ID #: 0120U100655
• Status: Completed
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: July 1, 2019

Study information

• Verified date: July 2022
• Source: Anesthesia Research Group UA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Arrhythmias are really common in patients after cardiac surgery. Most of the patients get sedation after cardiac surgery. The goal is to determine if the propofol (PR) (sedative agent), dexmedetomidine (DEX)(selective α2-adrenergic receptor (α2-AR) agonist) or their combination could improve and decrease the incidence of the arrhythmia in patients after cardiac surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 356
• Est. completion date: July 1, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)
• Age of patients from 18-80 years;

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Arrythmia

Intervention

Drug:
• Propofol
comparing sedative agents
• Dexmedetomidine
comparing sedative agents
• Dexmedetomidine and propofol
comparing sedative agents

Locations

Country	Name	City	State
Ukraine	Medical Network Dobrobut	Kyiv

Sponsors (1)

Lead Sponsor	Collaborator
Anesthesia Research Group UA

Country where clinical trial is conducted

Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)