Main
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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:
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ANZCTR |
Last refreshed on:
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13 January 2020 |
Main ID: |
ACTRN12614001012662 |
Date of registration:
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19/09/2014 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Effect Of Two Doses Of Magnesium Sulfate On
Hemodynamic Stability During Induction And Orotracheal Intubation In Adult Diabetic Patients
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Scientific title:
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Effect Of Two Doses Of Magnesium Sulfate On
Hemodynamic Stability During Induction And Orotracheal Intubation In Adult Diabetic Patients
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Date of first enrolment:
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11/11/2015 |
Target sample size:
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50 |
Recruitment status: |
Completed |
URL:
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https://anzctr.org.au/ACTRN12614001012662.aspx |
Study type:
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Interventional |
Study design:
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Purpose: Prevention; Allocation: Randomised controlled trial;
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Phase:
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Phase 2
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Countries of recruitment
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Egypt
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Contacts
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Name:
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Dr doaa rashwan
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Address:
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benisuef university
faculty of medicine egypt,benisuef governerate
,mokbel,mohamad anwar hassan street, 62511
Egypt |
Telephone:
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+208222318605 |
Email:
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doaa_rashwan2007@yahoo.com |
Affiliation:
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Name:
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Dr doaa rashwan
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Address:
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benisuef university
faculty of medicineegypt,benisuef governerate
,mokbel,mohamad anwar hassan street, 62511
Egypt |
Telephone:
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+208222318605 |
Email:
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doaa_rashwan2007@yahoo.com |
Affiliation:
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Anaesthesiology - Anaesthetics
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Diabetes;Hemodynamic Stability During Induction And Orotracheal Intubation; Diabetes Hemodynamic Stability During Induction And Orotracheal Intubation
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Metabolic and Endocrine - Diabetes
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Intervention(s)
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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
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Primary Outcome(s)
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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. ]
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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. ]
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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. ]
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Secondary Outcome(s)
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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.
]
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Source(s) of Monetary Support
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dr doaa rashwna
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Ethics review
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Status: Approved
Approval date:
Contact:
benisuef ethical comitee
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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