Determining the effect of Medonex on the hemodynamics of patients undergoing coronary bypass with cardiopulmonary pump compared to the placebo group
Design
Blocked randomized clinical trial, three blinded, parallel, on 78 patients with the method of concealing the closed envelope
Settings and conduct
On the day before surgery, all patients were admitted to the cardiac surgery department, and diuretics, calcuim channel blocker, and angiotensin-converting enzyme inhibitors were stopped, but beta blockers and statins were continued.
On the day of the operation, non-invasive monitoring is installed for the patient, which includes: electrocardiography, ..
After recording the basic vital signs information in the checklist the infusion of drugs is established according to the previous explanations. The drugs are prepared and prescribed by the nurse anesthetist who is not involved in recording the information.
Variables are recorded at the time of arrival and at the times specified in the checklist by an anesthetist who is blinded to the study groups.
The anesthetist does not know about the groups.
Participants/Inclusion and exclusion criteria
Age 35 to 75 referred to educational medical hospital, who is a candidate for coronary bypass surgery with an elective cardiopulmonary pump
Intervention groups
Intervention group, Medonex is diluted in saline with a concentration of 0.1 microgram per kilogram per milliliter. Start with an infusion pump: within 10 minutes as a loading dose (1 microgram per kilogram) at a rate of 60 milliliter per hour. Maintenance dose of (0.5 microgram per kilogram per hour) until the end of the surgery.
Control group, normal saline solution is started with an infusion pump aat a rate of 60 ml per hour.
Main outcome variables
Mean arterial pressure, heart rate, Hemodynamic criteria based on the ultrasonic cardiac output monitor device
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130428013159N13
Registration date:2023-04-15, 1402/01/26
Registration timing:registered_while_recruiting
Last update:2023-04-15, 1402/01/26
Update count:0
Registration date
2023-04-15, 1402/01/26
Registrant information
Name
Shima Sheybani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3764 7230
Email address
sheybanish@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-10, 1401/10/20
Expected recruitment end date
2023-07-11, 1402/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Medonex on hemodynamics of patients undergoing coronary artery bypass grafting
Public title
Evaluation of the effect of Medonex on patients undergoing open heart surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 35 to 75 referring to eduacational medical hospital
ASA class II
Candidates for coronary bypass surgery with an elective cardiopulmonary pump,
Exclusion criteria:
Emergency operation
Simultaneous heart valve operation
Underlying lung or liver or kidney, thyroid or gastrointestinal disease (nausea-vomiting-diarrhea)
History of previous heart surgery
Fever
Trauma
Carotid artery occlusion
Diabetes
Difficult and longer intubation than 20 seconds
BMI more than 30 kg/m2
Patient with heart rate less than 50 per minute
History of heart bundle block
History of treatment with clonidine and methyldopa
Ejection fraction less than 35%
Age
From 35 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
78
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomize and determine the people of each group, the block method is used. The number of patients in each group is 40, and random blocks of 4, 6, and 8 are used to allocate samples to two intervention groups, P and M. The order of interventions is randomized within each block, and because the block sizes are also different, the person running the trial cannot infer subsequent treatment assignments.
Blinding (investigator's opinion)
Triple blinded
Blinding description
After obtaining informed consent from the patients, the patients will be randomly assigned to one of the study groups.
The checklist of intraoperative hemodynamic information is recorded by a person who is not aware of the groups.
Data analysts are also blinded to the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Azadi square, Mashhad University of Medical Sciences
Mean arterial pressure and heart rate and hemodinamic parameters in the attached tables at the end of the proposal. On entering the operating room, basic and hemodinamic information (T1) was recorded and at the time, 15 minutes after tracheal intobation (T2) and at the time, 15 minutes after From the sternotomy (T3) and 15 minutes after the start of the cardiopulmonary bypass pump (T4) and 30 minutes after disconnecting from the cardiopulmonary bypass pump (T5) by the anesthesia assistant, the dose is recorded in the checklist. Total propofol, sufentanil, fentanyl, epinephrine, dobutamine, nitroglycerin, norepinephrine, and atropine are recorded in the checklist at the end of the procedure.
Timepoint
Mean arterial pressure and heart rate and hemodynamic parameters in the attached tables at the end of the proposal. On entering the operating room, basic and hemodynamic information (T1) was recorded and at the time, 15 minutes after tracheal intubation (T2) and at the time, 15 minutes after From the sternotomy (T3) and 15 minutes after the start of the cardiopulmonary bypass pump (T4) and 30 minutes after disconnecting from the cardiopulmonary bypass pump (T5) by the anesthesia assistant, the dose is recorded in the checklist. Total propofol, sufentanil, fentanyl, epinephrine, dobutamine, nitroglycerin, norepinephrine, and atropine are recorded in the checklist at the end of the procedure.
Method of measurement
Checklist for measuring vital signs from monitoring USCOM
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:in the intervention group, Medonex is diluted in saline with a concentration of 0.1 μg/kg/ml. Start with an infusion pump: within 10 minutes as a loading dose (1 μg/kg) at a rate of 60 ml/hour and then for a maintenance dose as 0.5 micrograms/kg/hour (continues until the end of surgery).
Category
Treatment - Drugs
2
Description
Control group:
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem hospital
Full name of responsible person
Shima Sheybani
Street address
Ahmadabad, Ghaem hospital,
City
Mashhad
Province
Razavi Khorasan
Postal code
9176999311
Phone
+98 51 3840 0000
Email
sheybanish@mums.ac.ir
2
Recruitment center
Name of recruitment center
Imamreza hospital
Full name of responsible person
Shima Sheybani
Street address
Imamreza Squre, Ibn Sina Street, Imamreza hospital,
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
sheybanish@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayour-Mobarhan
Street address
Ghoreshi Building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3804 9080
Fax
Email
Mgr.te@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Shima Sheybani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Ahmadabad, Ghaem hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9176999311
Phone
+98 51 3840 0000
Email
sheybanish@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Shima Sheybani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Qaim Hospital , Ahmad Abad Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9176999311
Phone
+98 51 3840 0000
Email
sheybanish@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Shima Sheybani
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
GHaem hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9176999311
Phone
009838405100
Email
sheybanish@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All data including the main outcome can be shared.
When the data will become available and for how long
6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
For use in research related to the subject after obtaining permission from the researchers of this project
From where data/document is obtainable
sheybanish@mums.ac.ir
What processes are involved for a request to access data/document
Sending a message to Dr. Sheybani's email and waiting for a reply for a maximum of one week.