In this randomized, double blind trial, we evaluate the effects of Magnesium sulfate (MgSO4) administration on postoperative analgesia & opioid requirement in patient undergoing inguinal hernia repairment operation. In this study thirty –two ASA 1&2 patients undergoing inguinal surgery in Imam Khomeini Hospital at Sari were divided randomly in two equal intervention & control groups. Patients with renal disease; liver disease; heart block; hypertension; psychosomatic disorders; myopathy; diabetes; history of drug & alcohol abuse; recent use of antidepressants& anti-psychotic drugs; calcium channel blocking drugs & thyroid disorders will be Excluded from the study. In intervention group patients receive Magnesium Sulfate 50 mg/kg/h IV, 15 minutes before until one hour after surgery whereas patients in control group received same volume of isotonic sodium chloride over the same time. Pain and requirement for analgesia will be recorded at immediately after surgery & 2; 6; 12; & 24 hours after surgery. Data are collected & will be analyzed with SPSS 16.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138809282883N1
Registration date:2012-03-03, 1390/12/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-03-03, 1390/12/13
Registrant information
Name
Mohammadreza Habibi
Name of organization / entity
Mazandarn University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 15 1222 3023
Email address
mhabibi@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2010-04-21, 1389/02/01
Expected recruitment end date
2010-08-20, 1389/05/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Magnesium Sulfate on postoperative analgesia in inguinal hernia repair
Public title
Effects of Magnesium Sulfate on postoperative analgesia in inguinal hernia repair
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria :Adults scheduled for inguinal hernia operation ; ASA class I and II; between 15& 75 years old .
Exclusion criteria : renal disease; liver disease; heart block; hypertension; psychosomatic disorders; myopathy; diabetes; history of drug & alcohol abuse; recent use of antidepressants& anti-psychotic drugs; calcium channel blocking drugs & thyroid disorders.
Age
From 15 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
32
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
mazandaran university of medical sciences
Street address
jooybar ave
City
sari
Postal code
Approval date
2010-07-07, 1389/04/16
Ethics committee reference number
8946
Health conditions studied
1
Description of health condition studied
inguinal hernia
ICD-10 code
k40
ICD-10 code description
Inguinal hernia
Primary outcomes
1
Description
pain
Timepoint
Immediately after surgery & 2;6;12 & 24 hour after surgery
Method of measurement
VAS score
Secondary outcomes
1
Description
amount of opioid
Timepoint
Immediately after surgery & 2;6;12 & 24 hour after surgery
Method of measurement
A nurse submitted the data
Intervention groups
1
Description
The intervention group recieve Magnesium Sulfate 50 mg/kg/h IV, 15 minutes before until one hour after surgery.
Category
Treatment - Drugs
2
Description
The control group received same volume of isotonic sodium chloride over the same time.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam khomeini Hospital
Full name of responsible person
Mohammad Reza Habibi
Street address
Amir BLV.
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran Uiversity of Medical Sciences and Health Services
Full name of responsible person
Ahmad Ali Enayati
Street address
Deputy of Research, Moalem sq.
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran Uiversity 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
Mazandaran University of Medical Sciences
Full name of responsible person
Mohammad Reza Habibi
Position
Assistant Professor; Fellowship of Cadiac Anesthesia
Other areas of specialty/work
Street address
Mazandaran Heart Center; fattemeh alzahra Hos. Sari