Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001012662
Ethics application status
Approved
Date submitted
31/08/2014
Date registered
19/09/2014
Date last updated
3/04/2017
Type of registration
Prospectively registered

Titles & IDs
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
Secondary ID [1] 285267 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 292916 0
Hemodynamic Stability During Induction And Orotracheal Intubation 292917 0
Condition category
Condition code
Anaesthesiology 293203 293203 0 0
Anaesthetics
Metabolic and Endocrine 293204 293204 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 290147 0
Prevention
Intervention code [2] 290148 0
Treatment: Drugs
Comparator / control treatment
M 30 group control group ( n = 25): will receive magnesium sulfate 30 mg/kg added to 100 ml of normal saline over 15 minutes before induction of general anesthesia
Control group
Dose comparison

Outcomes
Primary outcome [1] 293072 0
The systolic arterial blood pressure
noninvasive monotoring
Timepoint [1] 293072 0
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.
Primary outcome [2] 293073 0
diastolic arterial blood pressure
noninvasive monotoring
Timepoint [2] 293073 0
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.
Primary outcome [3] 293074 0
mean arterial blood pressure
noninvasive monotoring
Timepoint [3] 293074 0
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 [1] 310291 0
heart rate
ECG
Timepoint [1] 310291 0
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.

Eligibility
Key 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.
Minimum age
40 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/09/2014
Actual
11/11/2015
Date of last participant enrolment
Anticipated
Actual
30/11/2016
Date of last data collection
Anticipated
Actual
30/11/2016
Sample size
Target
50
Accrual to date
Final
50
Recruitment outside Australia
Country [1] 6331 0
Egypt
State/province [1] 6331 0

Funding & Sponsors
Funding source category [1] 289887 0
Self funded/Unfunded
Name [1] 289887 0
dr doaa rashwna
Country [1] 289887 0
Egypt
Primary sponsor type
Individual
Name
dr doaa rashwan
Address
egypt
benisuef university
faculty of medicine
egypt,benisuef governerate
,mokbel,mohamad anwar hassan street, 62511
Country
Egypt
Secondary sponsor category [1] 288567 0
None
Name [1] 288567 0
Address [1] 288567 0
Country [1] 288567 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291610 0
benisuef ethical comitee
Ethics committee address [1] 291610 0
egypt,benisuef governerate
,mokbel,mohamad anwar hassan street, 62511
Ethics committee country [1] 291610 0
Egypt
Date submitted for ethics approval [1] 291610 0
02/09/2014
Approval date [1] 291610 0
10/11/2015
Ethics approval number [1] 291610 0

Summary
Brief summary
Patients and Methods:
After approval of the ethical committee in Beni Suef University (Egypt), a written informed consent will be obtained from 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.

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.
All patients will be prepared preoperatively by taking history, examination, routine investigations.

On arrival to the operating theatre, 18 G intravenous cannula will be inserted and IV crystalloid fluids will be infused ,the monitor will be attached to the patients to take preoperative readings of heart rate, non-invasive arterial blood pressure,SpO2
The patients will be randomly divided using closed envelope
technique for randomization to one of two groups:
M 30 group ( n = 25): will receive 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 magnesium sulfate 50 mg/kg

added to 100 ml of normal saline over 15 minutes before induction of general anesthesia


General anesthesia will be induced after preoxygenation for 3- 5 minute with 100% oxygen by facemask, then induction of anesthesia in all patients will be with the use of i.v. propofol 2 mg/ kg slowly, fentanyl 2 micogram/ kg, atracurium (0.5mg/kg) and will be ventilated manually with sevoflorane 2 volume % ,oxygen 100% via a face mask then oral cuffed endotracheal tube will be inserted by expert anesthesiologist.
Hypotension (systolic blood pressure less than 90 mmHg) will be treated with volume replacement and ephedrine as indicated. Persistent hypertension (systolic blood pressure more than 160 mmHg lasting more than one minute) will be treated with IV nitroglycerin. Tachycardia (heart rate more than 120 beats/min) will be treated with IV boluses of esmolol. Bradycardia (heart rate less than 50 beats/minute) will be treated with 0.5 mg atropine IV.
At the end of surgery, neuromuscular blockade will be reversed with IV neostigmine 0.04mg/kg and atropine 0.02 mg/kg, the trachea will be extubated when the patient respond to commands, all patients will be transferred to PACU, where they receive oxygen via face mask 3-4 L/min and will be monitored.

The following parameters will be evaluated and recorded by senior anesthesiologist unaware of the study protocol:
1. Demographic data: age, sex, weight, height.
2. The systolic , diastolic , mean arterial blood pressure and heart rate 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.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1618 1618 0 0
/AnzctrAttachments/367020-eth..docx (Ethics approval)

Contacts
Principal investigator
Name 51138 0
Dr doaa rashwan
Address 51138 0
benisuef university
faculty of medicine
egypt,benisuef governerate
,mokbel,mohamad anwar hassan street, 62511
Country 51138 0
Egypt
Phone 51138 0
+208222318605
Fax 51138 0
Email 51138 0
[email protected]
Contact person for public queries
Name 51139 0
Dr doaa rashwan
Address 51139 0
benisuef university
faculty of medicineegypt,benisuef governerate
,mokbel,mohamad anwar hassan street, 62511
Country 51139 0
Egypt
Phone 51139 0
+208222318605
Fax 51139 0
Email 51139 0
[email protected]
Contact person for scientific queries
Name 51140 0
Dr doaa rashwan
Address 51140 0
benisuef university
faculty of medicine egypt,benisuef governerate
,mokbel,mohamad anwar hassan street, 62511
Country 51140 0
Egypt
Phone 51140 0
+208222318605
Fax 51140 0
Email 51140 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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