Protocol summary

Summary
Objective: Effect of magnesium sulfate on intraoperative hemodynamic undergoing cerebral ‎aneurism surgery and rate of postoperative cerebral vasospasm. Design: Interventional, Randomized, Single blind (researchers were not aware), Target sample size : 46 People.‎ Setting and conduct: The magnesium group received magnesium sulfate 50% (20 mg/per kg) (manufactured by Pasteur Institute of Iran), diluted ‎in 100 cc normal saline over 15 min before anesthetic induction. Then, 10 mg/kg/h of magnesium sulfate with saline ‎solution is infused within fifteen minutes for the patients after clip application. If the mean arterial pressure decreases to ‎less than 80 mmHg, propofol infusion, fentanyl, and magnesium sulfate are reduced or stopped to maintain the arterial ‎pressure in 80-100 mmHg range, before clip application. In the normal saline group, the same volume of magnesium ‎sulfate is administered to the patients. Intraoperative fluid management is performed according to the standard ‎procedures (4-2-1 rule); bleeding is compensated by a three-fold increase in magnesium and 0.9% normal saline.‎ Participants including major inclusion criteria:‏ candidate for brain aneurysm surgery after 3 days of aneurysm bleeding;‎ American Society of Anesthesiologists (ASA) class I and II.‎ Participants including major exclusion criteria:‎ pathology of cardiovascular system; heart failure [Ejection fraction (EF) less than ‎‎40%],‎ Previous history of hypertension; Liver or kidney diseases (impaired Liver function ‎test (FT) and Glomerular filtration rate (GFR) less than 50 ml/min); Motor, ‎neurological, and muscle disorders, coagulopathy [Prothrombin time (PT) more than ‎‎16, International Normalized Ratio (INR) more than 1.5; Partial thromboplastin ‎time (PTT) more than 35]; Hypomagnesaemia, More than 60 years of age;‎ History of allergy to any of the used medications in the experiment,‎ ‎ Overweight [Body mass index (BMI) more than 30]; Previous use of calcium channel ‎blockers; Atrioventricular block.‎ Intervention group: Magnesium sulphate 50%, 20 mg/kg, during 15 minutes before infusion of anesthesia and 10 mg/kg/hour till 15 minutes after end of improvising the tresses. Control group: Normal Saline 0.9%, Fluid therapy During surgery according to standard procedures (Rule 4-2-1) and compensation bleeding occurs with three times of Normal Saline 0.9%. Primary outcome measure: Vasospasm after intervention, Daily, By angiography and transcranial Doppler

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013042813159N1
Registration date: 2014-06-14, 1393/03/24
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-06-14, 1393/03/24
Registrant information
Name
Shima Sheybani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3764 7230
Email address
sheybanish@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Mashhad University of Medical Sciences
Expected recruitment start date
2014-05-25, 1393/03/04
Expected recruitment end date
2015-05-25, 1394/03/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing effect of magnesium sulfate and normal saline on intraoperative hemodynamic of patients undergoing cerebral ‎aneurism surgery and rate of postoperative cerebral vasospasm‎
Public title
Evaluation of effect of magnesium sulfate on reduction of cerebral vasospasm‎
Purpose
Treatment
Inclusion/Exclusion criteria
The major inclusion criteria‏:‏ candidate for brain aneurysm surgery after 3 days of aneurysm bleeding;‎ American Society of Anesthesiologists (ASA) class I and II.‎ The major exclusion criteria:‎ pathology of cardiovascular system; heart failure [Ejection fraction (EF) less than ‎‎40%]. Previous history of hypertension; Liver or kidney diseases (impaired Liver function ‎test (FT) and Glomerular filtration rate (GFR) less than 50 ml/min); Motor, ‎neurological, and muscle disorders, coagulopathy [Prothrombin time (PT) more than ‎‎16, International Normalized Ratio (INR) more than 1.5; Partial thromboplastin ‎time (PTT) more than 35]; Hypomagnesaemia, More than 60 years of age;‎ History of allergy to any of the used medications in the experiment,‎ ‎ Overweight [Body mass index (BMI) more than 30]; Previous use of calcium channel ‎blockers; Atrioventricular block.‎
Age
From 20 years old to 61 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 46
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Patients using a randomized block split into two groups of 23 people magnesium sulphate and normal saline. Researchers are unaware.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street, Mashhad
City
Mashhad
Postal code
Approval date
2013-11-16, 1392/08/25
Ethics committee reference number
920552

Health conditions studied

1

Description of health condition studied
Cerebral aneurism ‎
ICD-10 code
160.7
ICD-10 code description
Subarachnoid haemorrhage from intracranial artery, unspecified

Primary outcomes

1

Description
Vasospasm
Timepoint
After intervention, daily
Method of measurement
Angiography and transcranial Doppler

2

Description
Mean arterial pressure
Timepoint
Before infusion, 5 minutes after infusion, every 15 minutes after infusion
Method of measurement
Arterial Line during the surgery

3

Description
Heart rate
Timepoint
Before infusion, 5 minutes after infusion, every 15 minutes after infusion
Method of measurement
Heart monitoring during the surgery

Secondary outcomes

1

Description
Bleeding rate
Timepoint
End of surgery
Method of measurement
Based on CC of gases and suction contents

2

Description
The amount of anesthetic drugs used (propofol 2 mg/kg, fentanyl 2 mcg/kg, atracurium 0.5 mg/kg lidocaine 1.5 mg/kg)
Timepoint
End of surgery
Method of measurement
Based on patient weight (kg) and Duration of Surgery

Intervention groups

1

Description
Intervention group: Magnesium sulphate 50%, 20 mg/kg diluted in 100 ml of saline normal, manufactured by Pasteur Institute of Iran, during 15 minutes before infusion of anesthesia and 10 mg/kg/hour till 15 minutes after end of improvising the tresses
Category
Treatment - Drugs

2

Description
Control group: Normal Saline 0.9%, Fluid therapy During surgery according to standard procedures (Rule 4-2-1) and compensation bleeding occurs with three times of Normal Saline 0.9%
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Shima Sheybani
Street address
Anesthesia group, Ghaem Hospital, Mashhad
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street, Mashhad
City
Mashhad
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, Mashhad 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
Ghaem Hospital
Full name of responsible person
Houman Bahar Vahdat
Position
Assistant Professor
Other areas of specialty/work
Street address
Ghaem Hospital, Ahmadabad Avenue, Mashhad
City
Mashhad
Postal code
Phone
+98 51 1801 2616
Fax
Email
baharvahdath@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Shima Sheybani
Position
Assistant Professor
Other areas of specialty/work
Street address
Anesthesia Department, Ghaem Hospital, Mashhad
City
Mashhad
Postal code
Phone
+98 51 1801 2612
Fax
Email
sheybanish@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Shima Sheybani
Position
Assistant Professor
Other areas of specialty/work
Street address
Anesthesia Department, Ghaem Hospital, Mashhad
City
Mashhad
Postal code
Phone
00
Fax
Email
sheybanish@mums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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