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

Anesthesia Research Group UA

Status: Completed

Conditions: Arrythmia

Treatments: Drug: Dexmedetomidine; Drug: Propofol; Drug: Dexmedetomidine and propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT05450497

0120U100655

Details and patient eligibility

About

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.

Full 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.

Enrollment: 356 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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356 participants in 3 patient groups

Propofol Group

Experimental group

Description:

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

Treatment:

Drug: Propofol

Dexmedetomidine

Experimental group

Description:

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

Treatment:

Drug: Dexmedetomidine

Dexmedetomidine and propofol

Experimental group

Description:

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

Treatment:

Drug: Dexmedetomidine and propofol