Purpose: This study is prospective, randomized, double-blinded and clinical trial. 80 patients candidate for spinal anesthesia in cesarean section were chosen and divided randomly to same groups. Method and intervention: Patients were randomly assigned into two groups. The first group of patients is received Magnesium sulfate and group two is received normal saline as placebo. Immediately start inject drug after spinal anesthesia, the first group of patients is received 30mg/kg Magnesium sulfate (The maximum dose is 4 gr of magnesium infusion) We dilute it in 50 cc normal saline and infuse at 30 minutes and in group two (control group) infuse 50 cc normal saline as placeb, the surgeon and patients are bline about the type of drug. Inclusion/exclusion criteria: Inclusion criteria:
caesarean section under spinal anesthesia in a Pregnant women with ASA I
exclusion criteria: ASAII and above; Fever before surgery(T>38) and Hypothermia(T<36.5); Absolute prohibition for spinal anesthesia; Allergy to case study drugs; Thyroid Disease; Parkinson; Raynaud's syndrome; Ischemic heart disease; cerebrovascular disorders; Intraoperative blood transfusion; time of surgery more than 120 minutes; administration of Magnesium; administration of of pethidine; Hypertension; renal disease; history of use of cardiac and Hypertension drug. Primary and Secondary outcome: shiver,temperature. Secondary outcome: Blood pressure, Heart rate, Nausea & Vomiting. Control group: received 50cc Normal saline. Intervention group: received 30mg/kg so4 that dilute in 50cc Normal saline.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201308254780N4
Registration date:2013-09-05, 1392/06/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-09-05, 1392/06/14
Registrant information
Name
Mohammad Alipour
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1801 2612
Email address
alipourm@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Mashhad Univercity of Medical Sciences
Expected recruitment start date
2012-11-21, 1391/09/01
Expected recruitment end date
2013-04-21, 1392/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effects of magnesium sulfate and placebo in prevention of shivering during spinal anesthesia in cesarean section
Public title
Effects of magnesium sulfate in prevention of shivering during spinal anesthesia in cesarean section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: caesarean section under spinal anesthesia in a Pregnant women with ASA I.
Exclusion criteria: ASAII and above; Fever before surgery(T>38) and Hypothermia(T<36.5); Absolute prohibition for spinal anesthesia; Allergy to case study drugs; Thyroid Disease; Parkinson; Raynaud's syndrome; Ischemic heart disease; cerebrovascular disorders; Intraoperative blood transfusion; time of surgery more than 120 minutes; administration of Magnesium; administration of of pethidine; Hypertension; renal disease; history of use of cardiac and Hypertension drug.
Age
From 18 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Ethics Committee of Mashhad University of Medical Sciences
Street address
Vice Chancellor for Research, Mashhad University of Medical Science, Ghoreishi apartment, Daneshgah street
City
Mashhad
Postal code
Approval date
2012-10-13, 1391/07/22
Ethics committee reference number
910049
Health conditions studied
1
Description of health condition studied
Spinal anesthesia
ICD-10 code
O29.5
ICD-10 code description
Other complications of spinal and epidural anaesthesia during pregnancy
Primary outcomes
1
Description
shiver
Timepoint
During opreation every 15 minutes to 120 minutes
Method of measurement
Rate of Crossely & Mahajan
2
Description
Temperature
Timepoint
Befor spinal anesthesia and every 15 minutes to 120 minutes during surgery
Method of measurement
Genius 2 Electronic Thermometer
Secondary outcomes
1
Description
Blood pressure
Timepoint
Every 15 minutes to 120 minutes during surgery
Method of measurement
Non-invasive with Cuff
2
Description
Heart rate
Timepoint
Every 15 minutes to 120 minutes during surgery
Method of measurement
monitoring
3
Description
Nausea & Vomiting
Timepoint
Every 15 minutes to 120 minutes during surgery
Method of measurement
Observation and question
Intervention groups
1
Description
Intervention group: received 30mg/kg Magnesium sulfate ( dilute it in 50 cc normal saline)
Category
Treatment - Drugs
2
Description
Control group: received 50 cc of normal saline
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Dr Mohammad Alipour
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Mashhad University of Medical Science
Full name of responsible person
Dr Tavakol Afshar
Street address
Vice Chancellor for Research, Mashhad University of Medical Science, Ghoreishi apartment, Daneshgah street
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 Science
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
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohammad Alipour
Position
Anesthesiologist
Other areas of specialty/work
Street address
Ghaem Hospital
City
Mashhad
Postal code
Phone
+98 51 1801 2612
Fax
Email
Alipourm@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
Dr Mohammad Alipour
Position
Anesthesiologist
Other areas of specialty/work
Street address
Ghaem hospital
City
Mashhad
Postal code
Phone
+98 51 1801 2612
Fax
Email
Alipourm@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Cardiac Anesthesia Research Center, Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohammad Alipour
Position
Anesthesiologist
Other areas of specialty/work
Street address
Ghaem hospital
City
Mashhad
Postal code
Phone
+98 51 1801 2612
Fax
Email
Alipourm@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)