Protocol summary

Summary
The purpose of this study is to determine the effect of Mg sulfate on arterial blood pressure, heart rate, need to non-depolarizing muscle relaxants, and arterial O2 saturation on vertebral column surgeries. A total of 50 patients who are candidates of vertebral column surgery over a one-year period, were recruited and randomly assigned to receive Mg sulfate or normal saline, as placebo, as bolus dose before the surgery and continuous administration during the surgery. Blood pressure, pulse rate, non-depolarizing muscle relaxants will be measured and compared between groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138902023773N1
Registration date: 2011-01-13, 1389/10/23
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-01-13, 1389/10/23
Registrant information
Name
Farsad Imani
Name of organization / entity
Tehran University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 21 4469 0816
Email address
imanifar@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences and Health Services
Expected recruitment start date
2003-12-21, 1382/09/30
Expected recruitment end date
2004-12-21, 1383/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Magnesium effect on cardiovascular status & muscle relaxation during anesthesia, randomized clinical trial
Public title
Magnesium effect on cardiovascular status & muscle relaxation during anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: ASA class 1 and 2, scheduled for spine surgery Exclusion criteria: age>75, receiving sedatives, Antipsychotic, Calcium channel blocker drugs, Addicts to opium, Sensitive to magnesium and Hypertensive patients (more than 145/110)
Age
From 25 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
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
Tehran University of Medical Sciences
Street address
Ghods St., Keshavarz Bvd.
City
Tehran
Postal code
Approval date
2010-07-31, 1389/05/09
Ethics committee reference number
744/130/د/89

Health conditions studied

1

Description of health condition studied
Anesthesia
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Heart rate
Timepoint
Permanent, but recoding is every 20 minutes during 1st hour then every hour
Method of measurement
By operating room monitoring instrument: BiOSYS company

2

Description
Blood pressure
Timepoint
Every 20 minutes during 1st hour then every hour
Method of measurement
Non invasive blood pressure monitoring instrument: BiOSYS company

3

Description
Muscle relaxation
Timepoint
Every 20 minutes during 1st hour then every hour
Method of measurement
peripheral nerve stimulator (model Innervator252 HEALTHCARE -Constant Current-)

Secondary outcomes

1

Description
Consumed Opium
Timepoint
During operation
Method of measurement
Microgram opium

2

Description
Pulse oximetry
Timepoint
Permanent
Method of measurement
pulse oximetry monitoring instrument: BiOSYS company

Intervention groups

1

Description
Magnesium, sulfate 50 mg/kg/10min, before induction of anesthesia and 8 mg/kg/h, intravenously throughout the surgery
Category
Treatment - Drugs

2

Description
Normal saline, 0.2 milliliter/kg/10min, IV, before induction of anesthesia and then 0.1 milliliter /kg/h throughout the surgery
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Farsad Imani, Anesthesiologist, Assistant professor
Street address
Imam Khomeini St. hasanabad Sq. Sina Hospital
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences and Health Services
Full name of responsible person
Farsad Imani
Street address
Imam Khomeini St. hasanabad Sq. Sina Hospital
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences and Health Services
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
Tehran University of Medical Sciences and Health Services
Full name of responsible person
Farsad Imani
Position
Anesthesiologist, Assistant professor
Other areas of specialty/work
Street address
Imam Khomeini St. hasanabad Sq. Sina Hospital
City
Tehran
Postal code
1136746911
Phone
+98 66 3485 0010
Fax
+98 66348555
Email
imanifar@tums.ac.ir
Web page address
http://sinahospital.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences and Health Services
Full name of responsible person
Farsad Imani
Position
Anesthesiologist, Assistant professor
Other areas of specialty/work
Street address
Imam Khomeini St. hasanabad Sq. Sina Hospital
City
Tehran
Postal code
1136746911
Phone
+98 66 3485 0010
Fax
+98 66348555
Email
imanifar@tums.ac.ir
Web page address
http://sinahospital.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences and Health Services
Full name of responsible person
Farsad Imani
Position
Anesthesiologist, Assistant professor
Other areas of specialty/work
Street address
Imam Khomeini St. hasanabad Sq. Sina Hospital
City
Tehran
Postal code
1136746911
Phone
+98 66 3485 0010
Fax
+98 66348555
Email
imanifar@tums.ac.ir
Web page address
http://sinahospital.tums.ac.ir

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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