Protocol summary

Summary
According to anti-hypertensive drugs should be withdrawn before surgery, nowadays it is accepted that some drugs effectively control systemic blood pressure to assure its desirable therapeutic control. So in this study, the efficacy of angiotensin inhibitors before the CABG surgery on hemodynamic changes was surveyed. the inclusion criteria for the patients were having the history of involvement of the coronary arteries, the blockage of two to three major vessels, having the history of high blood pressure, and for the use or not use of angiotensin inhibitor drugs in patients to control blood pressure and The exclusion criteria of the study included the history of renal and hepatic failure, pregnancy, record of angioedema, allergy to angiotensin inhibitor. For the research 54 patients randomly were selected from the patients hospitalized in the cardiac surgery ward of Ahvaz Golestan Hospital. They were divided into two groups of 27 patiants. The first group did not use angiotensin inhibitor to control blood pressure but the second group consumed it. In these groups, the amount of vasoactive drug needed for the patients and the efficiency of angiotensin inhibitor on hypotension rate before , during, and after surgery, and the amount of vasopressor drugs which needed were surveyed .

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013100514862N1
Registration date: 2013-11-23, 1392/09/02
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-11-23, 1392/09/02
Registrant information
Name
Mansooreh Atarian
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1222 0168
Email address
attarian.m@agum.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2013-01-15, 1391/10/26
Expected recruitment end date
2013-07-20, 1392/04/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of angiotensin inhibitor before coronary bypass on hemodynamic changes and need to vasoactive medicines
Public title
The effect of blood pressure medicines in Coronary Artery operation
Purpose
Treatment
Inclusion/Exclusion criteria
the inclusion criteria: involvement of the coronary arteries; the blockage of two to three major vessels; history of high blood pressure; hyperlipidemia; the use of angiotensin inhibitor drugs; none use of angiotensin inhibitor drugs The exclusion criteria:renal failure; hepatic failure; pregnancy; record of angioedema; allergy to angiotensin inhibitor
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 54
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Science , Ahvaz ,Iran
City
Ahvaz
Postal code
iran
Approval date
2013-01-08, 1391/10/19
Ethics committee reference number
ETh-664

Health conditions studied

1

Description of health condition studied
Cardiovascular disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease

Primary outcomes

1

Description
Blood-Oxygen Saturaion
Timepoint
Pre Operation, Operation, Post Operation
Method of measurement
Pulse Oximeter

2

Description
blood pressure
Timepoint
pre Operation,Operation,Post operation
Method of measurement
Pressure Measurement

Secondary outcomes

empty

Intervention groups

1

Description
This study included 27 persons (control group) who did not use angiotensin inhibitors to control blood pressure. They used drugs such as 20 mg Metoral four times a day and 50 mg Atenolol twice a day in order to control blood pressure. In this group, their hemodynamic changes were evaluated before, during, and after the CABG surgery.
Category
Treatment - Drugs

2

Description
The other group included 27 persons (experimental group) who received the angiotensin inhibitor with the dosage of 25 mg twice a day and underwent surgery by general anesthesia. The experiment group patients, who are explained above, used only blood pressure medication or if they received a second drug like β-blocker, the dosage forms would be the same. In this group of patients, the needed amount of vasoactive drugs, the efficacy of angiotensin inhibitor on the hypotension rate during surgery, and induction, and the needed amount of vasopressor drugs were surveyed
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Atarian Mansooreh
Street address
Department of Anesthesiology, Ahvaz Jundishapur University of Medical Science,Golestan St, Ahvaz, Iran
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Deputy Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mostafa Feghhi
Street address
Ahvaz Jundishapur University of Medical Sciences,Golestan St, Ahvaz, Iran
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Deputy Ahvaz 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Atarian Mansooreh
Position
Resident
Other areas of specialty/work
Street address
Department of Anesthesiology, Ahvaz Jundishapur University of Medical Science,Golestan St, Ahvaz, Iran
City
Ahvaz
Postal code
Phone
+98 61 1222 0168
Fax
Email
attarian.m@agum.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Ebadi Ahmed
Position
َAssociate proffesor
Other areas of specialty/work
Street address
Department of Anesthesiology, Ahvaz Jundishapur University of Medical Science,Golestan St, Ahvaz, Iran
City
Ahvaz
Postal code
15794-61357
Phone
+98 61 1222 0168
Fax
Email
a_ebadi@hotmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Atarian Mansooreh
Position
Resident
Other areas of specialty/work
Street address
Department of Anesthesiology, Ahvaz Jundishapur University of Medical Science,Golestan St, Avaz, Iran
City
Ahvaz
Postal code
15794-61357
Phone
+98 61 1222 0168
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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