1. Home
  2. Approved trials
  3. » فارسی

Evaluation of I.V magnesium sulfate effect on post-operative pain of cesarean section after induction of spinal anesthesia

Protocol summary

Summary
We are evaluating the effect of I.V infusion of magnesium sulfate during spinal anesthesia on post-operative analgesia and postoperative analgesic requirement. This is a randomized, double blind, prospective study. Exclusion criteria are allergic reaction to study drug, cardiovascular, hepatic or renal dysfunction, neuromuscular diseases, opioid or analgesic abuse, prior treatment with calcium channel blockers. 68 ASA 1 patients, undergoing elective cesarean section under spinal anesthesia, are included. 15 min before induction of spinal anesthesia the magnesium group receive magnesium sulfate 50mg/kg for 15 min and then 10 mg/kg/h by continuous I.V infusion until the end of surgery. The saline group receive the same volume of isotonic saline over the same period. Post-operative pain and analgesic requirement will be evaluated immediately after surgery and at 0.5, 1, 2, 4, 8 and 24 h after surgery.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201111045731N2
Registration date: 2011-12-09, 1390/09/18
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-12-09, 1390/09/18
Registrant information
Name
Reza Tahmasebi
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 6562
Email address
r.tahmasebi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamedan University Of Medical Sciences
Expected recruitment start date
2011-08-23, 1390/06/01
Expected recruitment end date
2011-12-22, 1390/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of I.V magnesium sulfate effect on post-operative pain of cesarean section after induction of spinal anesthesia
Public title
Effect of magnesium sulfate on post-operative pain of cesarean section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1- ASA 1 women; 2- undergoing elective caesarian section. Exclusion criteria: 1-allergic reaction to study drug; 2- cardiovascular, hepatic or renal dysfunction; 3- neuromuscular diseases; 4- opioid or analgesic abuse; 5- prior treatment with calcium channel blockers.
Age
From 15 years old to 50 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 68
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
Hamaedan University of Medical Sciences
Street address
Mahdiye street
City
Hamaedan
Postal code
Approval date
2010-07-14, 1389/04/23
Ethics committee reference number
57205/9/35/16/پ

Health conditions studied

1

Description of health condition studied
pain
ICD-10 code
R52
ICD-10 code description
Pain, not elsewhere classified

Primary outcomes

1

Description
pain score
Timepoint
immediately after surgery and at 0.5, 1, 2, 4, 8 and 24 h after surgery
Method of measurement
with VAS score

Secondary outcomes

1

Description
heart rate
Timepoint
immediately after surgery and 0.5, 1, 2, 4, 8 and 24 h after surgery
Method of measurement
pulse per minute

2

Description
shivering, nausea and vomiting
Timepoint
immediately after surgery and 0.5, 1, 2, 4, 8 and 24 h after surgery
Method of measurement
The patient's complaint

3

Description
blood pressure
Timepoint
blooimmediately after surgery and 0.5, 1, 2, 4, 8 and 24 h after surgery
Method of measurement
manometer

Intervention groups

1

Description
15 min before induction of spinal anesthesia the magnesium group receive magnesium sulfate 50mg/kg for 15 min and then 10 mg/kg/h by continuous I.V infusion until the end of surgery.
Category
Treatment - Drugs

2

Description
The saline group receives the same volume of isotonic saline over the same period.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Hamedan Fatemieh Hospital
Full name of responsible person
Dr Maryam Davoodi
Street address
Kermanshah avenue
City
Hamedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Ali Galeeiha
Street address
Mahdiye street
City
Hamedan
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
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
Hamedan university of medical sciences
Full name of responsible person
Dr Reza Tahmasebi
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Mahdiye street, Hamedan university of medical sciences
City
Hamedan
Postal code
Phone
+98 81 1838 6562
Fax
Email
tahmaseb.reza90@yahoo.com , r.tahmasebi@umsha.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Reza Tahmasebi
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Mahdiye street, Hamedan University of Medical Sciences
City
Hamedan
Postal code
Phone
+98 81 1838 6562
Fax
Email
tahmaseb.reza90@yahoo.com , r.tahmasebi@umsha.ac.ir
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...