The effect of intravenous magnesium sulfate on intraocular pressure changes following tracheal intubation in adults in Shiraz University affiliated hospital
Magnesium sulfate a cost effective and safe drug. Magnesium can act as adrenergic antagonist and inhibited the release of catecholamines. One of the most problems in the anesthesia is control of pressure responses due to laryngoscopic intubation. This study was designed to assess the effect of magnesium sulfate on pressure responses of laryngoscopic intubation in anesthesia including hypertension, tachycardia and increased in intraocular pressure (IOP).
This randomized, double blind study was conducted in 180 patients ASA I that were undergoing non ocular surgery. The magnesium group A (n 90) received 30 mg/kg before induction of anesthesia and group B (n 90) received the same volume of normal saline. Intra ocular pressure, hemodynamic variables and heart rate measured in 4 stages: before induction of anesthesia (T1), just before intubation (T2), 1minute after intubation (T3), and 5 minute after intubation (T4).
These revealed significant interaction effect when comparing IOP in two groups in T2 to T3; (P=0.031).
There were significant differences between in the Systolic BP (p= 0.018), in the Diastolic BP (p= 0.01), in the Mean BP (p= 0.027), in two groups across levels of time.
There was not an overall significant difference in the heart rate between two groups. (P= 0.524)
Intravenous magnesium sulfate before induction of anesthesia reduced pressure responses of laryngoscopic intubation, and attenuated Iop in the time of before and after intubation. This attenuation is might be related to reduction in the release of catecholamine and vasodilatation of smooth muscle of systemic vessels.
Keyword: magnesium sulfate, Iop.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138812013376N1
Registration date:2011-02-16, 1389/11/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-02-16, 1389/11/27
Registrant information
Name
Dr. Fatemeh Karami Tireh Shabankareh
Name of organization / entity
Shiraz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 71 1233 7636
Email address
fakarami@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research Affairs of Shiraz University of Medical Science , Anesthesia department
Expected recruitment start date
2007-07-23, 1386/05/01
Expected recruitment end date
2009-09-16, 1388/06/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of intravenous magnesium sulfate on intraocular pressure changes following tracheal intubation in adults in Shiraz University affiliated hospital
Public title
The effect of Magnesium sulphate on increased intra ocular pressure due to general anesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 180 patients (ASA I) healthy adult, (18 to 38years old, both man and woman) that were scheduled for elective non ocular surgery (ENT and ambulatory surgery that needed tracheal intubation), were selected. exclusion criteria: The patients with specific major hepatic, renal and cardio-vascular disease as well as those known to have allergic reaction to magnesium sulphate or other drugs on basis of the history of patients, and hypermagnesemia, hypocalcemia on the basis on lab data, anuria, heart block (ECG), pregnancy, any degree of renal insufficiency, digitalised patients, positive history of glaucoma, or intra ocular hypertension, and patients who refused to participate in this study, were excluded.
Age
From 18 years old to 38 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
180
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
Shiraz University of Medical Science
Street address
Shiraz, Zand avenue, Central building of Shiraz University of Medical Science
City
Shiraz
Postal code
71345 - 1978
Approval date
2008-03-16, 1386/12/26
Ethics committee reference number
3905-86
Health conditions studied
1
Description of health condition studied
Persons encountering health services for specific procedures and health care
ICD-10 code
Z40 - Z41
ICD-10 code description
Persons encountering health services for specific procedures and health care
Primary outcomes
1
Description
iop (Intra ocular pressure)
Timepoint
In 4 stage (T1:Before induction of anesthesia ,T2 :Just before intubation , T3:1 minute after intubation ,T4:5 minute after intubation
Method of measurement
TONOPEN Instrument
Secondary outcomes
1
Description
Systolic BP
Timepoint
4 stages ; T1 :Before Induction of anesthesia , T2 : just before intubation ,T3 : 1 minute after intubation, T4 :5 minute after intubation
Method of measurement
NIBP monitoring
2
Description
Diastolic BP
Timepoint
4 stages ; T1 :Before Induction of anesthesia , T2 : just before intubation ,T3 : 1 minute after intubation, T4 :5 minute after intubation
Method of measurement
NIBP monitoring
3
Description
Mean Arterial Pressure
Timepoint
4 stages ; T1 :Before Induction of anesthesia , T2 : just before intubation ,T3 : 1 minute after intubation, T4 :5 minute after intubation
Method of measurement
NIBP monitoring
4
Description
Heart Rate
Timepoint
4 stages ; T1 :Before Induction of anesthesia , T2 : just before intubation ,T3 : 1 minute after intubation, T4 :5 minute after intubation
Method of measurement
EKG monitoring
Intervention groups
1
Description
administration of magnesium sulphate once 30mg/kg IV before induction of Anesthesia
Category
Prevention
2
Description
administration of normal saline once 30mg/kg IV before induction of Anesthesia
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Khalili and Dastgheib Shiraz University affiliated hospitals
Full name of responsible person
Fatemeh Karami tire shabankare
Street address
Shiraz University of medical of science,Faghihi hospital, nesthesia department
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Shiraz University of Medical Science,Anesthesia department
Full name of responsible person
Dr Mohammad ali sahmeddini
Street address
Shiraz university of Medical Science, central buldding,7th stairs,research and technology center
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Shiraz University of Medical Science,Anesthesia department
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
Shiraz Universityof Medical Science
Full name of responsible person
Dr Sina Ghaffari pour
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Shiraz, Shahid Faghihi Hospital, Department of Anesthesia
City
Shiraz
Postal code
7134844119
Phone
+98 71 1233 7636
Fax
+98 71 1230 7072
Email
sina50@gmail.com
Web page address
www.sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical of Science Department of Anesthesia
Full name of responsible person
Dr Sina Ghaffari poor
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Shiraz, Shahid Faghihi Hospital ,Anesthesia Department
City
Shiraz
Postal code
7134844119
Phone
+98 71 1233 7636
Fax
+98 71 1230 7072
Email
sina50@gmail.com
Web page address
www.sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Science
Full name of responsible person
Fatemeh karami Tire Shabankare
Position
Anesthesia Resident
Other areas of specialty/work
Street address
Shiraz, Shahid Faghihi Hospital. Anesthesia Department
City
Shiraz
Postal code
7134844119
Phone
+98 71 1233 7636
Fax
+98 71 1230 7072
Email
fakarami@sums.ac.ir;fkarami36@yahoo.com
Web page address
www.sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)