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

Not Applicable

Completed

• Conditions: Arrythmia
• Interventions: Drug: Propofol; Drug: Dexmedetomidine; Drug: Dexmedetomidine and propofol

• Registration Number: NCT05450497
• Lead Sponsor: Anesthesia Research Group UA

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.

Detailed 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.

Study Timeline

• Study Start: 2017-07-01
• Primary Completion: 2019-07-01
• Study Completion: 2019-07-01
• Study First Submitted: 2022-06-30
• Status Verified: 2022-07
• Study First Submitted QC: 2022-07-05
• Last Update Submitted: 2022-07-05
• Study First Posted: 2022-07-08
• Last Update Posted: 2022-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 356

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propofol Group	Propofol	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
Dexmedetomidine	Dexmedetomidine	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
Dexmedetomidine and propofol	Dexmedetomidine and propofol	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

Primary Outcome Measures

Name	Time	Method
incidence of arrhythmia	day of the discharge from the hospital (assessed up to day 5)	incidence of deviation from the rhythm before the surgery and at the day of the discharge from the hospital after cardia surgery

Trial Locations

Locations (1)

Medical Network Dobrobut; 🇺🇦 Kyiv, Ukraine