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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05450497
Enrollment
356
Registered
2022-07-08
Start date
2017-07-01
Completion date
2019-07-01
Last updated
2022-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arrythmia

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.

Interventions

DRUGPropofol

comparing sedative agents

DRUGDexmedetomidine

comparing sedative agents

DRUGDexmedetomidine and propofol

comparing sedative agents

Sponsors

Anesthesia Research Group UA
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
incidence of arrhythmiaday 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

Countries

Ukraine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026