The Effect of Low Dose and High Dose Magnesium Sulphate on Hemodynamic Changes during Sternotomy and Laryngoscopy in Patients Undergoing Coronary Artery Bypass Graft Surgery
Objective:Hemodynamic stability during anesthesia and surgery is one of the basic goals that every anesthesiologist wishes to achieve. Laryngoscopy and sternotomy are two major stresses to human body that could alter heart rate and blood pressure significantly .The primary goal of this study was to evaluate the effect of low and high doses of magnesium sulfate on mean arterial pressure of patients undergoing CABG during laryngoscopy and sternotomy and compare it with the placebo.Design:Randomized placebo controlled.Methods:90 patients were randomly allocated in to three groups.Intervention:Patients in group one received a 20mg/kg bolus dose of magnesium sulphate over a period of 3 minutes followed by an infusion of magnesium sulphate(10 mg/kg/hour).
Patients in group two received a 40mg/kg bolus dose of magnesium sulphate over a period of 3 minutes followed by an infusion of magnesium sulphate(20 mg/kg/hour). Patients in group three received placebo.
Exclusion Criteria:Patients with left ventricular ejection fraction less than 40% , left ventricular aneurysm, valvular heart disease, previously documented hypertension and diabetes mellitus were not enrolled in the study.
Outcome measures:Heart rate and blood pressure were recorded on arrival and before intubation and 2 and 4 minutes after intubation and 1 minute before sternotomy and 2 and 4 minutes after sternotomy.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201209235140N7
Registration date:2014-11-23, 1393/09/02
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-11-23, 1393/09/02
Registrant information
Name
Omid Azimaraghi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2206 6194
Email address
cazimaraghi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences, Dr. Shariati Hospital
Expected recruitment start date
2014-12-01, 1393/09/10
Expected recruitment end date
2015-03-01, 1393/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Low Dose and High Dose Magnesium Sulphate on Hemodynamic Changes during Sternotomy and Laryngoscopy in Patients Undergoing Coronary Artery Bypass Graft Surgery
Public title
The effect of Magnesium Sulphate on hemodynamics
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients refered to our anesthesia clinic; Patients aged 40 to 80 years undergoing Coronary Artery Bypass Graft Surgery
Exclusion Criteria:Patients with left ventricular ejection fraction less than 40% ; left ventricular aneurysm;valvular heart disease; previously documented hypertension; diabetes mellitus
Age
From 40 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee, Faculty of medicine of Tehran University of Medical Sciences
Street address
Research deputy, Ethics Committee of Tehran University of Medical Sciences, 6th floor, Tehran University of Medical Sciences building, Ghods St,Keshavarz Blvd
City
Tehran
Postal code
Approval date
2013-02-01, 1391/11/13
Ethics committee reference number
25612/2321
Health conditions studied
1
Description of health condition studied
Other and unspecified disorders of circulatory system
ICD-10 code
I99
ICD-10 code description
Other and unspecified disorders of circulatory system
Primary outcomes
1
Description
Heart rate during intubation
Timepoint
Before intubation and 2 and 4 minutes after intubation
Method of measurement
Using patients monitoring
2
Description
Heart rate during sternotomy
Timepoint
Before sternotomy and 2 and 4 minutes after
Method of measurement
Using patients monitoring
Secondary outcomes
1
Description
Blood pressure during intubation
Timepoint
Before intubation and 2 and 4 minutes after
Method of measurement
Using sphygmomanometer
2
Description
Blood pressure during sternotomy
Timepoint
Before sternotomy and 2 and 4 minutes after
Method of measurement
Using sphygmomanometer
Intervention groups
1
Description
Patients in group one received a 20mg/kg bolus dose of magnesium sulphate over a period of 3 minutes followed by an infusion of magnesium sulphate10 mg/kg/hour
Category
Prevention
2
Description
Patients in group two received a 40mg/kg bolus dose of magnesium sulphate over a period of 3 minutes followed by an infusion of magnesium sulphate(20 mg/kg/hour).
Category
Treatment - Drugs
3
Description
Patients in group three received saline as placebo for bolus and infusion.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Shariati Hospital
Full name of responsible person
Dr. Omid Azimaraghi
Street address
Dr Shariati Hospital, North Kargar Ave ,Amirabad
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor of research-Tehran University of Medical Sciences
Full name of responsible person
Dr. Shahin Akhoondzadeh
Street address
Vice Chancellor for research , Tehran University of Medical Sciences Tehran Tehran Iran, Islamic Republic Of
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor of research-Tehran 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
Dr Shariati Hospital
Full name of responsible person
Dr. Omid Azimaraghi
Position
Chief Resident of Anesthesiology
Other areas of specialty/work
Street address
Dr Shariati Hospital, North Kargar Ave ,Amirabad
City
Tehran
Postal code
Phone
+98 21 2206 6194
Fax
Email
o.azimaraghi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dr. Shariati Hospital
Full name of responsible person
Dr. Ali Movafegh
Position
Professor of anesthesiology
Other areas of specialty/work
Street address
Dr.Shariati Hospital, North Kargr ave, Amir Abad
City
Tehran
Postal code
Phone
+98 21 8822 0033
Fax
Email
movafegh@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Anesthesiology, Dr Shariati Hospital
Full name of responsible person
Dr. Omid Azimaraghi
Position
Chief resident of Anesthesiology
Other areas of specialty/work
Street address
Dr. Shariati Hospital, North Kargar Ave,Amir Abad,
City
Tehran
Postal code
Phone
+98 21 2206 6194
Fax
Email
o.azimaraghi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)