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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ANZCTR
Last refreshed on: 13 January 2020
Main ID:  ACTRN12614001012662
Date of registration: 19/09/2014
Prospective Registration: Yes
Primary sponsor: dr doaa rashwan
Public title: Effect Of Two Doses Of Magnesium Sulfate On Hemodynamic Stability During Induction And Orotracheal Intubation In Adult Diabetic Patients
Scientific title: Effect Of Two Doses Of Magnesium Sulfate On Hemodynamic Stability During Induction And Orotracheal Intubation In Adult Diabetic Patients
Date of first enrolment: 11/11/2015
Target sample size: 50
Recruitment status: Completed
URL:  https://anzctr.org.au/ACTRN12614001012662.aspx
Study type:  Interventional
Study design:  Purpose: Prevention; Allocation: Randomised controlled trial;  
Phase:  Phase 2
Countries of recruitment
Egypt
Contacts
Name: Dr doaa rashwan   
Address:  benisuef university faculty of medicine egypt,benisuef governerate ,mokbel,mohamad anwar hassan street, 62511 Egypt
Telephone: +208222318605
Email: doaa_rashwan2007@yahoo.com
Affiliation: 
Name: Dr doaa rashwan   
Address:  benisuef university faculty of medicineegypt,benisuef governerate ,mokbel,mohamad anwar hassan street, 62511 Egypt
Telephone: +208222318605
Email: doaa_rashwan2007@yahoo.com
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: 50 ASA II males and females patients aged 40-65 years old, with controlled type II diabetes mellitus planned for elective surgery under general anesthesia requiring orotracheal intubation.
Exclusion criteria: Patients will be excluded from the study if they had history of
type I diabetes mellitus, hypertension, cardiac disease, hypomagnesemia or hypermagenesmia , a known allergy to the study drugs, neuromuscular, liver and renal diseases ,suspected or history of difficult intubation, prolonged intubation longer than 30 secs or more than one attempt required, BMI >30 .
Patients undergoing cardiac and neurosurgical procedures will be also excluded.


Age minimum: 40 Years
Age maximum: 65 Years
Gender: Both males and females
Health Condition(s) or Problem(s) studied
Anaesthesiology - Anaesthetics
Diabetes;Hemodynamic Stability During Induction And Orotracheal Intubation;
Diabetes
Hemodynamic Stability During Induction And Orotracheal Intubation
Metabolic and Endocrine - Diabetes
Intervention(s)
The patients will be randomly divided using closed envelope
technique for randomization to one of two groups:
M 30 group ( n = 25): will receive intravenous magnesium sulfate 30 mg/kg added to 100 ml of normal saline over 15 minutes before induction of general anesthesia
M 50 ( n =25): will receive intravenous magnesium sulfate 50 mg/kg

added to 100 ml of normal saline over 15 minutes before induction of general anesthesia
Primary Outcome(s)
diastolic arterial blood pressure
noninvasive monotoring[ will be measured and recorded:
a- Before the administration of the study drug at baseline
b-after induction of anesthesia
c –at 1,5,10 minutes following tracheal intubation and before skin incision.
]
mean arterial blood pressure
noninvasive monotoring[will be measured and recorded:
a- Before the administration of the study drug at baseline
b-after induction of anesthesia
c –at 1,5,10 minutes following tracheal intubation and before skin incision.
]
The systolic arterial blood pressure
noninvasive monotoring[will be measured and recorded:
a- Before the administration of the study drug at baseline
b-after induction of anesthesia
c –at 1,5,10 minutes following tracheal intubation and before skin incision.
]
Secondary Outcome(s)
heart rate
ECG [ will be measured and recorded:
a- Before the administration of the study drug at baseline
b-after induction of anesthesia
c –at 1,5,10 minutes following tracheal intubation and before skin incision.
]
Secondary ID(s)
nil
Source(s) of Monetary Support
dr doaa rashwna
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date:
Contact:
benisuef ethical comitee
Results
Results available:
Date Posted:
Date Completed:
URL:
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