Comparison of the effects of magnesium sulfate at a dose of 30mg / kg compared to a dose of 40mg / kg on responses
Hemodynamics of tracheal intubation in patients undergoing CABG
Design
A randomized, placebo-controlled, placebo-controlled clinical trial on patients undergoing CABG
Settings and conduct
Patients III-IIASA are candidates for CABG Elective Surgery at Kashan Shahid Beheshti Hospital with EF greater than 40%. After obtaining written consent, they will be randomly divided into 4 groups with 4 blocks each. The operation continues until morning. Age, sex, weight, height, chronic illness and medications are recorded. All patients receive 1mg and 0.1mg / kg intramuscular morphine as pre-medication the night before surgery and one hour before surgery. After entering the operating room, patients are monitored by pulse oximeter, electrocardiogram, and non-invasive blood pressure.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients III-ASA II elective CABG candidate with EF greater than 40%. And ages 18 to 75 years.
Exclusion criteria: Emergency surgery - Probability of intubation problem - Magnesium sulfate sensitivity
Intervention groups
Group A: Magnesium sulfate is infused at 30mg / kg within 5 minutes, which continues before induction.
Group B: Magnesium sulfate 40mg / kg is infused over a period of 5 minutes, which continues before induction.
Group C: Normal saline equivalent to group
Main outcome variables
Body Mass Index, Systolic Pressure, Diastolic Pressure, Medium Blood Pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191229045935N1
Registration date:2020-03-04, 1398/12/14
Registration timing:retrospective
Last update:2020-03-04, 1398/12/14
Update count:0
Registration date
2020-03-04, 1398/12/14
Registrant information
Name
Jafar Kazemeini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5550 0111
Email address
kazemeini-j@mail.kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-27, 1397/12/08
Expected recruitment end date
2019-08-30, 1398/06/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison study of two doses of magnesium sulfate on hemodynamic response to endotracheal intubation in laparoscopic cholecystectomy
Public title
The effect of two different doses of the drug on hemodynamic responses in patients undergoing laparoscopic cholecystectomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
ASA II-III Patients Candidate for Laparoscopic Elective Cholecystectomy
Exclusion criteria:
Emergency Surgery
Probability of intubation problem
Sensitivity to magnesium sulfate
Cardiac arrhythmia
Serum creatinine above 2 mg / dl
pregnant women
Patients with severe heart valve disorders Patients with aortic stenosis
Age
From 18 years old to 75 years old
Gender
Both
Phase
0
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients III-IASA were candidates for elective laparoscopic elective cholecystectomy at Shahid Beheshti Hospital in Kashan after obtaining written consent random blocks with 6 blocks are divided into 3 groups. In the case of central hiding randomization, in this method, the random sequence is assigned to a particular person or center and sampling is performed at one or more centers simultaneously. Based on the order of the participants' entry into the study, the researcher communicates with the relevant center and asks about the random assignment of the participant to a specific group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients from two different doses of magnesium sulfate are completely blind to their hemodynamic responses.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kashan university of medical sciences, Qotbe Ravandi Blvd, Kashan
Street address
Kashan university of medical sciences, Qotbe Ravandi Blvd, Kashan
City
Kashan
Province
Isfehan
Postal code
8711111111
Approval date
2019-02-12, 1397/11/23
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1397.106
Health conditions studied
1
Description of health condition studied
Patients undergoing CABG
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Heart rate
Timepoint
At the time of tracheal, and 2, 4, 6, and 10 minutes after tracheal intubation.
Method of measurement
Digital barometer
2
Description
systolic blood pressure, diastolic blood pressure, and mean blood pressure
Timepoint
systolic blood pressure, diastolic blood pressure, and mean blood pressure before infusion to induction were recorded at different time points, including anesthesia induction, at the time of tracheal, and 2, 4, 6, and 10 minutes after tracheal intubation.
Method of measurement
Mercury barometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Magnesium sulfate 30mg / kg infusion within 5 minutes which continues before induction. The studied drugs were manufactured by Judge Tabriz Company from Alborz Broadcasting Company and recorded at the time of tracheal intubation, 2, 4, 6 and 10 minutes after tracheal intubation.nd 10 minutes after tracheal intubation.
Category
Treatment - Drugs
2
Description
Intervention group: Magnesium sulfate 40mg / kg is infused for 5 minutes and continues until induction. The studied drugs were manufactured by Judge Tabriz Company from Alborz Broadcasting Company and recorded at the time of tracheal intubation, 2, 4, 6 and 10 minutes after tracheal intubation.
Category
Treatment - Drugs
3
Description
Control group: Normal saline equal to the intervention group as placebo, which is infused like the other two groups within 5 minutes and will continue until induction.The studied drugs were manufactured by Judge Tabriz Company from Alborz Broadcasting Company and recorded at the time of tracheal intubation, 2, 4, 6 and 10 minutes after tracheal intubation.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashan Shahid Beheshti Hospital
Full name of responsible person
Mohammadreza Tashakor
Street address
Kashan university of medical sciences, Qotbe Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8711111111
Phone
+98 31 5550 0111
Email
kazemeini-j@mail.kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mohammadreza Tashakor
Street address
Kashan university of medical sciences, Qotbe Ravandi Blvd, Kashan
City
Kashan
Province
Isfehan
Postal code
8711111111
Phone
+98 31 5550 0111
Email
kazemeini-j@mail.kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Jafar Kazemeini
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Kashan university of medical sciences, Qotbe Ravandi Blvd, Kashan
City
Kashan
Province
Isfehan
Postal code
8711111111
Phone
+98 31 5550 0111
Email
kazemeini-j@mail.kaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Jafar Kazemaini
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Kashan university of medical sciences, Qotbe Ravandi Blvd, Kashan
City
Kashan
Province
Isfehan
Postal code
8711111111
Phone
+98 31 5550 0111
Email
kazemeini-j@mail.kaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Jafar Kazemaini
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Kashan university of medical sciences, Qotbe Ravandi Blvd, Kashan
City
Kashan
Province
Isfehan
Postal code
8711111111
Phone
+98 31 5550 0111
Email
kazemeini-j@mail.kaums.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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Some portion of the dose information can be shared.
When the data will become available and for how long
Starting access after printing the article.
To whom data/document is available
All researchers
Under which criteria data/document could be used
For use in surgeries
From where data/document is obtainable
Author corresponding
What processes are involved for a request to access data/document