Comparison of the Effectiveness of Pancronium and Cisatracorium In the amount of oxygen consumption When Cardiopulmunary Bypass in Coronary Artery Bypass Graft surgery
Checking the amount of oxygen used and lactate and acidosis in patients undergoing coronary artery bypass graft surgery underlying illness and diffuse atherosclerosis and predisposed to vascular disease and hemodynamic disorders
Design
This study is a parallel clinical trials study
Settings and conduct
Study population will be patients with acute coronary syndrome who have been referred to Ardabil Imam Khomeini hospital for elective coronary vessel grafting. 39 patients will be randomly allocated to two groups. Patients in one group will recieve cisatracurium while patients in the other group will recieve pancrunium. Later, the amount of intraoperative oxygen consumption will be calculated in both groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
a) Age:35 - 75
b) ASA Class: 2 or 3
c) EF 40% or More than
d) Elective surgery
Exclusion criteria:
a) Sigaret or Opiat users
b) Reoperation
c) Allergy to drugs that using Sever
d) Heart failure
Intervention groups
Intervention group 1: Patients receiving Pancuronium muscle relaxant at a rate of 1 microgram per kilogram body weight per minute
Intervention group 2:Patients receiving Cisatracurium at 3 micrograms per kg of body weight per minute
Main outcome variables
Changes in oxygen consumption in surgery were coronary artery bypass
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190608043842N1
Registration date:2019-09-23, 1398/07/01
Registration timing:retrospective
Last update:2019-09-23, 1398/07/01
Update count:0
Registration date
2019-09-23, 1398/07/01
Registrant information
Name
Azita Nikpoor
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3359 1154
Email address
a.nikpoor@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-23, 1397/08/01
Expected recruitment end date
2019-03-16, 1397/12/25
Actual recruitment start date
2018-12-31, 1397/10/10
Actual recruitment end date
2019-05-20, 1398/02/30
Trial completion date
2019-05-20, 1398/02/30
Scientific title
Comparison of the Effectiveness of Pancronium and Cisatracorium In the amount of oxygen consumption When Cardiopulmunary Bypass in Coronary Artery Bypass Graft surgery
Public title
Comparison of Pancronium and Cisatracorium in Reduse of oxygen Consumption
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age:35 - 75
ASA Class: 2 or 3
EF 40% or More than
Elective surgery
Exclusion criteria:
Sigaret or Opiat users
Reoperation
Allergy to drugs that using
Sever Heart failure
Age
From 35 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
54
Actual sample size reached:
39
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is a block type with 4 blocks and computer software.
Blinding (investigator's opinion)
Double blinded
Blinding description
In a double-blinded study, patients and the evaluator were blinded to the study procedure. Nevertheless, to prevent putting the patients at risk, there was no possibility of blinding for the anesthetis
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ardebil University of Medical Sciences
Street address
Ardabil University of Medical Sciences ,Daneshgah street
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۸۹-۸۵۹۹۱
Approval date
2018-12-26, 1397/10/05
Ethics committee reference number
IR.ARUMS.REC.1397.188
Health conditions studied
1
Description of health condition studied
Oxygen consumption in CABG surgery with CPB
ICD-10 code
I25.7
ICD-10 code description
Atherosclerosis of coronary artery bypass graft(s) and coronary artery of transplanted heart with angina pectoris
Primary outcomes
1
Description
Changes in oxygen consumption in surgery were coronary artery bypass Surgery
Timepoint
Oxygen Consumption Measurement at Beginning (0) , 15 , 30 and 45 Minutes after Start of Cardiopulmunary Bypass
Method of measurement
Instrument for Arterial Blood Gass (ABG) Assessmentation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Patients receiving Pancuronium muscle relaxant at a rate of 1 microgram per kilogram body weight per minute
Category
Treatment - Drugs
2
Description
Control group:Patients receiving Cisatracurium at 3 micrograms per kg of body weight per minute
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Mohammad Hasanpour
Street address
Imam Khomeini Hospital , The street of martyrs Dr. Salman and Salim Noie Aghdam , Ardabil
City
Ardebil
Province
Ardabil
Postal code
5619647531
Phone
+98 45 3325 1401
Fax
+98 45 3325 1401
Email
Drmhd3051@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr.Vadood Norouzi hassan borough
Street address
Fatemi Hospital , Shariati Square, Ardabil
City
Ardebil
Province
Ardabil
Postal code
5614733775
Phone
+98 45 3323 2520
Fax
+98 45 3323 2520
Email
V.norouzi@arums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr.Vadood Norouzi hassan barough
Position
Assistant Professor/Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Fatemi Hospital , Shariati Square, Ardabil
City
Ardabil
Province
Ardabil
Postal code
5614733775
Phone
+98 45 3323 2520
Fax
+98 45 3323 2520
Email
V.norouzi@arums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr.Vadood Norouzi hassan borough
Position
Assistant Professor/Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Fatemi Hospital , Shariati Square, Ardabil
City
Ardabil
Province
Ardabil
Postal code
5614733775
Phone
+98 45 3323 2520
Fax
+98 45 3323 2520
Email
V.norouzi@arums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr.Vadood Norouzi hassan borough
Position
Assistant Professor/Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Fatemi Hospital , Shariati Square, Ardabil
City
Ardabil
Province
Ardabil
Postal code
5614733775
Phone
+98 45 3323 2520
Fax
+98 45 3323 2520
Email
V.norouzi@arums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
all collected deidentified IPD, IPD collected for the primary outcome measure are to be shared.
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
documents will be available for people working in academic institutions and also people working in businesses.
Under which criteria data/document could be used
There will be no specific limitations to the utilization of the data.
From where data/document is obtainable
En Dr Mohammad Hassan pour-Imam khomeini Hospital , Ardabil; Islamic Republic of Iran Phone+98 452251401 Fax+98 452251401
What processes are involved for a request to access data/document