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

Sponsor

Anesthesia Research Group UA (Other)

Overall Status

Completed

CT.gov ID

NCT05450497

Collaborator

(none)

356

Enrollment

Location

Arms

Actual Duration (Months)

14.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Arrythmia	Drug: Propofol Drug: Dexmedetomidine Drug: Dexmedetomidine and propofol	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

356 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jul 1, 2017

Actual Primary Completion Date :

Jul 1, 2019

Actual Study Completion Date :

Jul 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Propofol Group 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 comparing sedative agents
Experimental: 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	Drug: Dexmedetomidine comparing sedative agents
Experimental: 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	Drug: Dexmedetomidine and propofol comparing sedative agents

Arm

Intervention/Treatment

Experimental: Propofol Group

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

comparing sedative agents

Experimental: 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

Drug: Dexmedetomidine

comparing sedative agents

Experimental: 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

Drug: Dexmedetomidine and propofol

comparing sedative agents

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical Network Dobrobut	Kyiv		Ukraine	01000

Sponsors and Collaborators

Anesthesia Research Group UA

Investigators

Study Chair: Yelyzaveta Plechysta, MD, Chief of the anesthesia department

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Plechysta Yelyzaveta, Chief of the anesthesia Department, Anesthesia Research Group UA

ClinicalTrials.gov Identifier:

NCT05450497

Other Study ID Numbers:

0120U100655

First Posted:

Jul 8, 2022

Last Update Posted:

Jul 8, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Arrhythmias, Cardiac

Dexmedetomidine

Propofol

Study Results

No Results Posted as of Jul 8, 2022