The aim of this clinical trial study is the assessment of intravenous infusion of Magnesium Sulfate for post Thorcotomy pain control. Therefore, in a double-blind RCT, 80 patients who were candidates for lateral Thoracotomy included and divided into two equal groups. First group undergone magnesium sulfate; 50 mg/kg as a bolus dose before starting surgery and continued with infusion rate of 500mg/hour up to 24 hours for postoperative period. Second group undergone normal saline (placebo) instead of magnesium sulfate. At the end of operation, muscle relaxant reversed and patients extubated. Anesthesia techniques were similar in the both groups. The Morphine PCA pumps were attached to all patients with: 20 minutes lockout time, 2 mg bolus dose, without basal infusion. After awaking, all patients transferred to ICU room. Pain intensity according VAS scale and dose of opioid consumption according milligram were recorded, at the time of 0, 2, 6, 12 and 24 postoperatively. Finally, pain score and amount of analgesic consumption were compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201107221772N8
Registration date:2012-03-13, 1390/12/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-03-13, 1390/12/23
Registrant information
Name
Dawood Aghamohammadi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1381 8940
Email address
aghamohammadid@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Anesthesiology Research Team
Expected recruitment start date
2010-03-21, 1389/01/01
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
Intravenous Infusion of magnesium sulfate in the control of post operative thracotomy pain
Public title
Effect of magnesium sulfate for post operative pain control
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria:
1) patients with ASA II-III
2) 20 t0 60 rang of age
3) All patients needs thorachotomy
Exclusion Criteria:
1) Drug sensitivities
2) avoidance of patient for drug infusion
3) addiction
4) bilateral thoracotomy
5) operation time more than 3 hours
6) Ejection Fraction less than 40%
7) pneumonectomy with less than 1.2 liter lung reserve in spirometry
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Tabriz University of Medical Sciences
Street address
Vice Chancellor of Research, Faculty of Medicine,Daneshghah Street
City
Tabriz
Postal code
Approval date
2011-04-06, 1390/01/17
Ethics committee reference number
5/4/323
Health conditions studied
1
Description of health condition studied
Thoracotoy
ICD-10 code
S21.1
ICD-10 code description
Open wound of front wall of thorax
2
Description of health condition studied
pain
ICD-10 code
R07.1
ICD-10 code description
Precordial pain
Primary outcomes
1
Description
Pain
Timepoint
Post operative time at 0, 2, 6, 12 and 24
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Rate of analgesic ( morphine) consumption
Timepoint
post operative time at0, 2, 6, 12 and 24
Method of measurement
Milligram Dose
Intervention groups
1
Description
Saline normal infusion as placebo in control group
Category
Placebo
2
Description
Bolus dose of magnesium Sulfate 50 mg/kg and maintenance dose 500mg /hour
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Teaching Hospital
Full name of responsible person
Dawood Aghamohammadi
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dawood Aghamohammadi
Street address
Anesthesiology research team office, Faculty of Medicine,Daneshghah Street,
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dawood Aghamohammadi
Position
Assistant Professor
Other areas of specialty/work
Street address
Anesthesiology research team office, Faculty of Medicine,Daneshghah Street