Effect of prophylactic injection of magnesium sulfate versus placebo on shivering after cesarean section under spinal anesthesia: a double-blind randomized clinical trial
To assess the effect of prophylactic injection of magnesium sulfate versus placebo on shivering after cesarean section under spinal anesthesia
Design
This is a double-blind randomized clinical trial, phase III, in which 60 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible patients who are candidate for cesarean referring to the Fetamieh Hospital in Hamadan city during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the block randomization. This trial will be double-blinded so that neither patients nor the physician examining the patients will be aware of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age of 18 to 45 years old; pregnant women; candidate for cesarean section.
Exclusion criteria: body temperature above 37.5 or below 36 degree centigrade; renal or liver diseases or muscular weakness; uncontrolled thyroiditis disease; Parkinson disease; dis-autonomy; Raynaud's syndrome; cardiovascular disease; alcohol consumption; taking vasodilator medications.
Intervention groups
Intervention group: intravenous infusion of magnesium sulfate 30 mg/kg in 40 ml normal saline for 15 minutes.
Control group: intravenous infusion of placebo (distilled water) in 40 ml normal saline for 15 minutes.
Main outcome variables
Primary outcome:
Shivering after spinal anesthesia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N380
Registration date:2021-02-02, 1399/11/14
Registration timing:prospective
Last update:2021-02-02, 1399/11/14
Update count:0
Registration date
2021-02-02, 1399/11/14
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-13, 1399/11/25
Expected recruitment end date
2022-02-14, 1400/11/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of prophylactic injection of magnesium sulfate versus placebo on shivering after cesarean section under spinal anesthesia: a double-blind randomized clinical trial
Public title
Effect of prophylactic injection of magnesium sulfate versus placebo on shivering after cesarean section under spinal anesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 45 years old
Pregnant women
Candidate for cesarean section
Exclusion criteria:
Body temperature above 37.5 or below 36 degree centigrade
Renal or liver diseases or muscular weakness
Uncontrolled thyroiditis disease
Parkinson disease
Dis-autonomy
Raynaud's syndrome
Cardiovascular disease
Alcohol consumption
Taking vasodilator medications
Age
From 15 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
Blinding (investigator's opinion)
Double blinded
Blinding description
The shape of the medications and placebos will be perfectly the same. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Thus, the trial will be run as double-blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2021-01-16, 1399/10/27
Ethics committee reference number
IR.UMSHA.REC.1399. 876
Health conditions studied
1
Description of health condition studied
Shivering
ICD-10 code
R25.1
ICD-10 code description
Tremor, unspecified
Primary outcomes
1
Description
Shivering after spinal anesthesia
Timepoint
Every 15 minutes until the end of the patient's presence in the recovery room
Method of measurement
With a clinical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intravenous infusion of magnesium sulfate 30 mg/kg in 40 ml normal saline for 15 minutes
Category
Treatment - Drugs
2
Description
Control group: Intravenous infusion of placebo (distilled water) in 40 ml normal saline for 15 minutes
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Fetamieh Hospital in Hamadan city
Full name of responsible person
Elaheh Sharifi Asa
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
judiabot1124@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Elaheh Sharifi Asa
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Genetics
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
judiabot1124@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Mahshid Nikooseresht
Position
Anesthesiologist
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
nikooseresht@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available