survey of preventive effect of intravenous magnesium sulphate on postoperative pain of pregnant women undergoing Cesarian section with general anesthesia in valiasr hospital in years: 91-92
this triple blinded, randomized study involves pregnant women who are scheduled for elective Cesarian section under general anesthesia in valiasr center of Imam Khomeini university hospital. 50 pregnant women are randomly allocated into intervention and control groups.patients in intervention group are received 50 mg/kg intravenous Mg sulphate in 100 ml normal saline during 15 minutes just before anesthesia induction which is continued by 15 mg/kg/hr infusion of Mg sulphate throughout the surgery. patients in control group are only received equal volume of normal saline as placebo.at the end of surgery all patients are given diclofenac suppository(100 mg)as a postoperative analgesic and are given intravenous morphine as a rescue analgesic in ward. degree of postoperative pain is assessed at 1,6,12 and 24 hours after surgery according to short-form McGill pain questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201212245225N3
Registration date:2013-01-01, 1391/10/12
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-01-01, 1391/10/12
Registrant information
Name
Seyed mohammad Mireskandari
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2261 8931
Email address
mireskandari@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
some part of it from educational budget of anesthesia department and the remaining from project implementers
Expected recruitment start date
2013-01-19, 1391/10/30
Expected recruitment end date
2013-03-19, 1391/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
survey of preventive effect of intravenous magnesium sulphate on postoperative pain of pregnant women undergoing Cesarian section with general anesthesia in valiasr hospital in years: 91-92
Public title
survey of preventive effect of magnesium sulphate on postoperative pain of pregnant women undergoing Cesarian section
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: pregnant women with ASA I,II (American Society of Anesthesiologists) scheduled for elective Cesarian section under general anesthesia
exclusion criteria: hypermagnesemia, insufficient time for giving study drugs,sensitivity to magnesium sulphate, heart blocks,hypertension,diabetes,renal disease, cardiovascular disease,history of analgesic intake during the past 24 hours,fetal distress, multiparity
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple 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 tehran university of medical sciences
Street address
ghods street,keshavarz boulvard
City
tehran
Postal code
Approval date
2012-10-19, 1391/07/28
Ethics committee reference number
90/د/130/1312
Health conditions studied
1
Description of health condition studied
pregnancy
ICD-10 code
O75.8
ICD-10 code description
Other specified complications of labour and delivery
Primary outcomes
1
Description
severity of postoperative pain
Timepoint
1st, 6th,12th,24th hours after cesarian section
Method of measurement
short MCGillL pain questionaire
Secondary outcomes
1
Description
hemodynamic changes( blood pressure and heart rate)
Timepoint
at induction and tracheal intubation and during surgical procedure and in recovery period
Method of measurement
by means of a mercury manometre and a cardiac monitor
2
Description
analgesic requirements
Timepoint
during 24 hours after completion of cesarian section
Method of measurement
by means of recorded amounts of infused analgesic which displayed on a PCA pomp
Intervention groups
1
Description
.patients in control group only received equal amount of normal saline as placebo.
Category
Placebo
2
Description
patients in intervention group were received 50 mg/kg intravenous Mg sulphate in 100 ml normal saline in 15 minutes just before surgical incision and 15 mg/kg/hr IV infusion of Mg sulphate thereafter.