Purpose: Clinical trial Comparison effects of magnesium sulfate and granisetron on prevention of shivering during spinal anesthesia in cesarean section.
A total of 80 pregnant women with ASA class I undergoing elective cesarean section to be chosen and a double blind randomized using a random number table is divided into two groups. The first group of patients magnesium sulfate received (Mg, n = 40) and patients in the group 2 (Group G, n = 40) received granisetron. After spinal anesthesia immediately began injecting drugs, the 30 mg / kg magnesium sulfate and dilute the volume of 50cc raised and within 30 minutes we were by syringe infusion pump, the maximum dose was 4 grams of magnesium infusion to consider. The other group granisetron in a dose of 40mcg/kg in the syringe injected encoded so that neither the researchers nor the patients had knowledge of the contents of the syringe. Inclusion criteria: Pregnant women who underwent spinal anesthesia for cesarean section are ASA class I. Exclusion criteria: Patients with ASA class II and above; Sensitivity to study drugs; Thyroid disease; Parkinson; Ischemic heart disease; Reception blood intraoperative; Surgery for more than 120 minutes or less than 30 minutes; History of pethidine; use of pethidine; Hypertension; Renal disease; usage of heart and blood pressure drug. Primary outcome: shiver, the temperature of the tympanic (by Genius 2 Electronic Thermometer) used to perform spinal and every 15 minutes to 120 minutes was measured during surgery. secondary outcom: Blood pressure and heart rate using the cuff and measured noninvasively monitoring device. Intervention group 1: 30mg/kg Magnesium sulfate diluted and brought to the volume of 50cc syringe infusion pump over 30 minutes we were. Intervention group 2 : Granisetron a dose of 40mcg/kg in the syringe injected encoded so that neither the researchers nor the patients had knowledge of the contents of the syringe.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201606144780N9
Registration date:2016-08-23, 1395/06/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-08-23, 1395/06/02
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
Mohammad Ali Alipour
Expected recruitment start date
2015-06-17, 1394/03/27
Expected recruitment end date
2016-01-17, 1394/10/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial Comparison effects of magnesium sulfate and granisetron on prevention of shivering during spinal anesthesia in cesarean section
Public title
Comparison effects of magnesium sulfate and granisetron on prevention of shivering during spinal anesthesia in cesarean section
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: Pregnant women who underwent spinal anesthesia for cesarean section are ASA class I.
Exclusion criteria: Patients with ASA class II and above; Sensitivity to study drugs; Thyroid disease; Parkinson; Ischemic heart disease; Reception blood intraoperative; Surgery for more than 120 minutes or less than 30 minutes; History of pethidine; use of pethidine; Hypertension; Renal disease; usage of heart and blood pressure drug.
Age
No age limit
Gender
Both
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
Not 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
Ghoreishi apartment, Daneshgah street
City
Mashhad
Postal code
Approval date
2015-05-27, 1394/03/06
Ethics committee reference number
IR.MUMS.fm.REC.135.55
Health conditions studied
1
Description of health condition studied
Intra and post spinal anesthesia shivering
ICD-10 code
R68.0
ICD-10 code description
Hypothermia, not associated with low environmental temperature
Primary outcomes
1
Description
shiver
Timepoint
Every 15 minutes to 120 minutes during surgery
Method of measurement
With Crossly and Mahjon five-point scoring system and tympanic thermometer devices
Secondary outcomes
1
Description
Blood pressure
Timepoint
Evey 15 minutes to 120 minutes during surgery
Method of measurement
Using a non-invasive cuff
2
Description
Heart rate
Timepoint
Every 15 minutes to 120 minutes during surgery
Method of measurement
With monitoring device
Intervention groups
1
Description
Intervention group 1: 30mg/kg Magnesium sulfate diluted and brought to the volume of 50cc syringe infusion pump over 30 minutes we were
Category
Treatment - Drugs
2
Description
Intervention group 2 : Granisetron a dose of 40mcg/kg in the syringe injected encoded so that neither the researchers nor the patients had knowledge of the contents of the syringe.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem and Emam Reza Hospitals
Full name of responsible person
Street address
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
Ghoreishi apartment, 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
Mashhad University of medical sciences
Full name of responsible person
Mohammad Ali Alipour
Position
Anesthesiologist
Other areas of specialty/work
Street address
Ghaem hospital
City
Mashhad
Postal code
Phone
+98 51 3801 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
Mohammad Ali Alipour
Position
anesthesiologist
Other areas of specialty/work
Street address
Ghaem hospital
City
Mashhad
Postal code
Phone
+98 51 3801 2612
Fax
Email
alipourm@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
Ehsan Mahdavi
Position
Anesthesiologist
Other areas of specialty/work
Street address
City
Mashhad
Postal code
Phone
00
Fax
Email
Mahdavie911@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)