Comparison effect of sodium nitroprusside effect on reducing of incidence and duration of atrial fibrillation after coronary artery bypass graft surgery
This study compared the effect of Sodium nitroprusside in reducing the incidence and duration of atrial fibrillation after coronary Artery Bypass graft surgery using cardio pulmonary Bypass is performed. People over 18 years who were only undergoing coronary bypass surgery and unknot previous history of arrhythmia and anemia and sever valvular disease and systematic disease studied and the sample size is 52 people, which is 26 case and 26 control.
During surgery and the start of the rewarming period for minutes in case 9% up given nitro preside and in the control group dextrose water 5% as a placebo.
So that the mean arterial pressure kept 65 MMHg. Then electrocardiogram daily for five dugs to prove the start and end of atrial fibrillation episodes will be logged.
General information
Acronym
does not have
IRCT registration information
IRCT registration number:IRCT2017031533055N2
Registration date:2017-05-30, 1396/03/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-05-30, 1396/03/09
Registrant information
Name
Zahra Fassihi
Name of organization / entity
JundiShapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3222 8037
Email address
fasihi.z@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahwaz Jundishapur University of Medical Sciences, Department of Research and Technology Development
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2016-12-20, 1395/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effect of sodium nitroprusside effect on reducing of incidence and duration of atrial fibrillation after coronary artery bypass graft surgery
Public title
Comparison effect of sodium nitroprusside effect on reducing of incidence and duration of atrial fibrillation after coronary artery bypass graft surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: All patients who underwent coronary artery bypass surgery are; patients older than 18 years; would like to participate in the study. Exclusion criteria: history of atrial fibrillation; history of surgery for coronary artery bypass; a history of severe disease; valvular; surgery to repair or replace the valve; the candidate of the current surgical repair or replace the valve; atrium size greater than normal echo cardiogram before surgery; history of anemia or severe electrolyte abnormalities before surgery; history of thyroid disease; syndrome sick sinus; bradycardia and significant changes in atrial conduction; patients with a permanent pacemaker fitted.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
This study is a randomized, double-blind, prospective, randomized controlled study for comparison of the effect of sodium nitroprusside in reducing the incidence and duration of atrial fibrillation after coronary artery bypass graft surgery in patients who are at the heart of Ahwaz Golestan hospital Bbymarstan you will Shvndanjam. Before the operation the patients provided written informed consent form and questionnaire included age, sex, weight, BMI original complaint, a family history of heart disease pre Machvr (first-degree relative under 65 and men under 55 years old), presence of hypertension (pressure ≥140 systolic and / or diastolic BP ≥90), dyslipidemia (increased triglycerides, cholesterol, LDL, decreased HDL), diabetes mellitus (fasting blood glucose ≥ mg / dl 126 (smoking and use of information by researcher interviewing patients the case is completed.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahwaz JundiShapur University of Medical Sciences
Street address
Ahwaz Golestan University of Medical Sciences Jundishapur
City
Ahwaz
Postal code
Approval date
2017-02-07, 1395/11/19
Ethics committee reference number
IR.AJUMS.REC.1395.751
Health conditions studied
1
Description of health condition studied
Atrial Fibrillation
ICD-10 code
I48
ICD-10 code description
Atial Fibrillation and flutter
Primary outcomes
1
Description
The incidence of atrial fibrillation after coronary artery bypass surgery
Timepoint
Within 5 days after coronary artery bypass surgery every day
Method of measurement
Within 5 days after coronary artery bypass surgery patients daily 12-lead ECG is taken. Start and end of each episode of atrial Fyrylasyvn recorded by the doctor.
2
Description
Time Dora atrial fibrillation after coronary artery bypass surgery
Timepoint
Within 5 days after coronary artery bypass surgery every day
Method of measurement
Within 5 days after coronary artery bypass surgery patients daily 12-lead ECG is taken. Start and end of each episode of atrial Fyrylasyvn recorded by the doctor.
Secondary outcomes
1
Description
Onset atrial fibrillation after coronary artery bypass surgery
Timepoint
Within 5 days after surgery daily
Method of measurement
12-lead ECG is taken daily for 5 days.
Intervention groups
1
Description
During the surgical treatment group and re-warming period starting dose of sodium nitroprusside Mg / Kg / Min 5-1% for 60 minutes will receiveSo that the mean arterial pressure without drugs or drugs Anytrvp increase of intravascular volume is maintained at 65 mm Hg.
Category
Treatment - Drugs
2
Description
Patients in the control group from start to finish re-serum dextrose water 5 percent to 200 cc, but 60 minutes into receive.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
The Training Center, Golestan Hospital
Full name of responsible person
Zahra Fassihi
Street address
Golestan Alley, Golestan Hospital
City
Ahwaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahwaz JundiShapur University of Medical Sciences
Full name of responsible person
Behzad Sharif Makhmalzadeh
Street address
Ahwaz Jundishapur University, Department of Research and Technology Development
City
Ahwaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahwaz JundiShapur University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Ahwaz Jundishapur University of Medical Sciences
Full name of responsible person
Seyed Mostafa Ariafar
Position
Professor of Cardiology
Other areas of specialty/work
Street address
The Training Center, Golestan Hospital
City
Ahwaz
Postal code
Phone
+98 61 3374 3352
Fax
Email
Armx51@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahwaz Jundishapur University of Medical Sciences
Full name of responsible person
Mohammad Ali Sheikhi
Position
Cardiovascular Surgery
Other areas of specialty/work
Street address
Ahvaz, Golestan Hospital, Department of Heart
City
Ahwaz
Postal code
Phone
+98 61 3374 3036
Fax
Email
Sheikhi.MA@YAHOO.COM
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahwaz Jundishapur University of Medical Sciences
Full name of responsible person
Zahra Fassihi
Position
Student
Other areas of specialty/work
Street address
The Training Center, Golestan Hospital
City
Ahwaz
Postal code
Phone
+98 61 3374 3036
Fax
Email
Drfassihi92@gmail.com fasihi.z@ajums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)