Protocol summary

Summary
This study is aimed to evaluate the effect of adding MgSO4 to intrathecal marcain to control shivering during cesarean section surgery with spinal anesthesia. Sixty patients, ASA physical status I or II, aged between 18 - 35 years, undergoing cesarean surgery in Rasoul Hospital during 2010 to 2011, are included in this randomized, prospective, double-blind and placebo-controlled study. Patients are randomized into two groups of 30 individuals. The control group receives normal saline and treatment group receives magnesium sulfate. The treatment group receives 2 cc of marcain 0.5% (10 mg) and 0.5 cc of magnesium sulfate 5% (25 mg) and control group receives 2 cc of marcain 0.5% and 0.5 cc of normal saline. Body temperature will be recorded before spinal block, immediately after spinal block and each 30 mine during 1 hour after admission to recovery. Indeed, vital sign, 5 minutes for 15 minutes then each 10 minutes till the end of recovery will be recorded. Sedation will be recorded, before spinal block, immediately after spinal block, each 30 minutes during 1 hour after admission to recovery. Shivering will be recorded during 90 minutes after spinal block in 0, 5, 10, 15, 20, 30, 40, 50, 60 and 90 minutes by physician who is unaware of the type of treatment given to the patients.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201101055182N4
Registration date: 2011-02-02, 1389/11/13
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-02-02, 1389/11/13
Registrant information
Name
Hamid Reza Faiz
Name of organization / entity
Tehran University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 21 4481 9954
Email address
h.faiz@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences and Health Services
Expected recruitment start date
2011-01-21, 1389/11/01
Expected recruitment end date
2012-01-21, 1390/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of the effect of adding Magnesium Sulfate to intrathecal Marcain to control shivering during cesarean section surgery with spinal anesthesia
Public title
The evaluation of the effect of adding Magnesium Sulfate to intrathecal Marcain to control shivering during cesarean section surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: ASA physical status I or II, age 18-35 years old, signing consent to participate in the study. Exclusion criteria: Patients not willing participate in project, pre-eclampsia, lidocaine and magnesium sulfate allergy, drug and alcohol abuse, neuropathy, infection in block site, respiratory distress, coagulopathy.
Age
From 18 years old to 35 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 60
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 and Health Services
Street address
Poorsina Ave.
City
Tehran
Postal code
Approval date
2010-08-01, 1389/05/10
Ethics committee reference number
890.1

Health conditions studied

1

Description of health condition studied
Shivering during cesarean section surgery
ICD-10 code
T88.5
ICD-10 code description
Hypothermia following anesthesia

Primary outcomes

1

Description
Shivering
Timepoint
During 90 minutes after spinal block in 0, 5,10,15,20,30,40,50,60 and 90 minutes
Method of measurement
None, Mild, Moderate, Severe

Secondary outcomes

1

Description
Central body temperature
Timepoint
Before spinal block, immediately after spinal block, each 30 mine during 1 hour after admission to recovery
Method of measurement
Thermometer

2

Description
Systolic arterial pressure
Timepoint
5 minutes for 15 minutes then each 10 minutes til the end of recovery
Method of measurement
Sphygmomanometer

3

Description
Heart rate
Timepoint
5 minutes for 15 minutes then each 10 minutes til the end of recovery
Method of measurement
Rate/min

4

Description
Sedation
Timepoint
Before spinal block, immediately after spinal block, each 30 minutes during 1 hour after admission to recovery
Method of measurement
Basd on Ramsy criteria

Intervention groups

1

Description
The magnesium sulfate group receive 2 cc marcain 0.5% (10 mg), 0.5 cc magnesium sulfate 5% (25 mg)
Category
Treatment - Drugs

2

Description
The control group receive 2 cc marcain 0.5% , 0.5 cc normal saline
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasoul Hospital
Full name of responsible person
Seyed Hamid Reza Feiz
Street address
Poorsina Ave.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences and Health Services
Full name of responsible person
Hamid Reza Feiz, MD
Street address
Poorsina Ave.
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
Hamid Reza Feiz MD
Position
Anesthesiologist/ Assistant Professor
Other areas of specialty/work
Street address
Poorsina Ave.
City
Tehran
Postal code
Phone
+98 21 4481 9954
Fax
Email
h.faiz@iums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rasoul Hospital
Full name of responsible person
Hamid Reza Feiz MD
Position
Anesthesiologist
Other areas of specialty/work
Street address
Poorsina Ave.
City
Tehran
Postal code
Phone
+98 21 4481 9954
Fax
Email
h.faiz@iums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences and Health Services
Full name of responsible person
Hamid Reza Faiz
Position
Anesthesiologist, Assistant professor
Other areas of specialty/work
Street address
Poorsina Ave.
City
Tehran
Postal code
Phone
+98 21 4481 9954
Fax
Email
h.faiz@iums.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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