Comparison of Different ِDoses of Magnesium Sulfate (30, 50, and 80 mg/kg) in Prevention of Postoperative Shivering in Patients Undergoing Spinal Anesthesia
Objectives: The purpose of this study is to compare different doses of magnesium sulfate (30, 50, and 80 mg) in the prevention of postoperative shivering in patients undergoing spinal anaesthesia. Design: This double-blind study is a randomized clinical trial with no placebo. Setting and conduct: Infusion through microset 15 minutes after spinal anesthesia. Participants: The study population includes 99 male and female patients aged between 20-80 years old in three groups of 33 each. The main inclusion criterion was not being allergic to the prescribed medicines and the main exclusion criterion was having a central temperature less than 36.5 degrees centigrade or higher than 38 during operation. Intervention: The intervention includes infusing magnesium sulfate to prevent postoperative shivering after spinal anaesthesia. The treatment will be after spinal anaesthesia and the infusion will be carried out in 15 minutes. Main outcome measures: The primary outcome is shivering which will be measured based on the observation scale for some hours after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017012432099N3
Registration date:2017-07-02, 1396/04/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-07-02, 1396/04/11
Registrant information
Name
Bahareh Ebrahimi
Name of organization / entity
Gonabad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 5722 3028
Email address
b.ebrahimi@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
ِDeputy for Research at Gonabad University of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2017-04-21, 1396/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Different ِDoses of Magnesium Sulfate (30, 50, and 80 mg/kg) in Prevention of Postoperative Shivering in Patients Undergoing Spinal Anesthesia
Public title
The Use of Magnesium Sulfate in Prevention of Postoperative Shivering
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: The patients must be between 20-80 years old; be willing to participate in the study; complete the informed consent form; not have cardiac nor pulmonary diseases; not have thyroid dysfunction; not be allergic to the prescribed medicines; not suffer from Parkinson’s disease; dysautonomia nor rhinod syndrome; not drink alcohol; not use vasodilator; have a central temperature of 36.5 degrees centigrade before the onset of operation; not suffer from neurologic nor psychological disorders; and have normal functioning of the kidneys and normal output of urine.
Exclusion Criteria: The occurrence of any kind of clinical outcome or condition that makes the postoperative evaluation impossible; having central temperature less than 36.5 degrees centigrade or higher than 38 during operation; and requiring transfusion during surgery.
Age
From 20 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
99
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
The Ethics Committee of Gonabad University of Medical Sciences
Street address
ِDeputy for Research at Gonabad University of Medical Sciences, Next to the Asian Road
City
Gonabad
Postal code
9691793718
Approval date
2016-07-20, 1395/04/30
Ethics committee reference number
IR.GMU.REC.1395.62
Health conditions studied
1
Description of health condition studied
shivering
ICD-10 code
T88.5
ICD-10 code description
Other complications of anaesthesia
Primary outcomes
1
Description
Shivering
Timepoint
َAfter the intervention, immediately after the infusion of magnesium sulfate, during the operation and one hour after the end of surgery
Method of measurement
Based on the observed measure
Secondary outcomes
1
Description
Blood Pressure
Timepoint
After the intervention every fifteen minutes during the operation and as long as one hour after the operation
Method of measurement
Based on mercury mm using sphygmomanometer
Intervention groups
1
Description
Group A will be infused once using magnesium sulfate 20% with a dose of 30 kg/mg and 100 cc volume using a microset after spinal anesthesia.
Category
Treatment - Drugs
2
Description
Group B will be infused once using magnesium sulfate 20% with a dose of 50 kg/mg and 100 cc volume using a microset for 15 minutes after spinal anesthesia.
Category
Treatment - Drugs
3
Description
Group C will be infused once using magnesium sulfate 20% with a dose of 80 kg/mg and 100 cc volume using a microset for 15 minutes after spinal anesthesia.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
15 khordad Bidokht Hospital
Full name of responsible person
Dr Mohsen Saheban Maleki
Street address
Bidokht
City
Gonabad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy for Research at Gonabad University of Medical Sciences
Full name of responsible person
Dr Ali Mohamadpor
Street address
Deputy for Research at Gonabad University of Medical Sciences, Next to the Asian Road
City
Gonabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy for Research at Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Bahareh Ebrahimi
Position
Student of Anesthesia
Other areas of specialty/work
Street address
Anaesthesia and Operating Room Department, Paramedicine Faculty of Gonabad University of Medical Sciences, Next to the Asian Road
City
Gonabad
Postal code
Phone
+98 51 5722 5027
Fax
Email
b.ebrahimi@gmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr Mohsen Saheban Maleki
Position
Anesthesiologist, ICU Fellowship, Associate Professor
Other areas of specialty/work
Street address
Anaesthesia and Operating Department, Paramedicine Faculty at Gonabad University of Medical Sciences, Next to the Asian Road
City
Gonabad
Postal code
Phone
+98 51 5722 5027
Fax
Email
Dr.saheban@gmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Mostafa Amiri
Position
Faculty Member, َAssistant Professor, PhD in TEFL
Other areas of specialty/work
Street address
Basic Science Department, School of Medicine at Gonabad University of Medical sciences, Next to the Asian Road
City
Gonabad
Postal code
9691793718
Phone
+98 51 5722 5027
Fax
+98 51 5722 3814
Email
Mu1amiry@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)