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

Primary Purpose

Arrythmia

Status
Completed
Phase
Not Applicable
Locations
Ukraine
Study Type
Interventional
Intervention
Propofol
Dexmedetomidine
Dexmedetomidine and propofol
Sponsored by
Anesthesia Research Group UA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Arrythmia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Medical Network Dobrobut

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Propofol Group

Dexmedetomidine

Dexmedetomidine and propofol

Arm 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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 30, 2022
Last Updated
July 5, 2022
Sponsor
Anesthesia Research Group UA
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1. Study Identification

Unique Protocol Identification Number
NCT05450497
Brief Title
Effect of Sedative Agent on Reducing the Frequency of Arrhythmia in the Patients After Cardiac Surgery
Official Title
Effect of Propofol vs Dexmedetomidine or Propofol+Dexmedetomidine on Reducing the Frequency of Arrhythmia in Patients After Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
July 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Anesthesia Research Group UA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrythmia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
356 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Propofol Group
Arm Type
Experimental
Arm 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
Arm Title
Dexmedetomidine
Arm Type
Experimental
Arm 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
Arm Title
Dexmedetomidine and propofol
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
comparing sedative agents
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
comparing sedative agents
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine and propofol
Intervention Description
comparing sedative agents
Primary Outcome Measure Information:
Title
incidence of arrhythmia
Description
incidence of deviation from the rhythm before the surgery and at the day of the discharge from the hospital after cardia surgery
Time Frame
day of the discharge from the hospital (assessed up to day 5)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yelyzaveta Plechysta, MD
Organizational Affiliation
Chief of the anesthesia department
Official's Role
Study Chair
Facility Information:
Facility Name
Medical Network Dobrobut
City
Kyiv
ZIP/Postal Code
01000
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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