Comparison between magnesium sulfate and paracetamol in Analgesic effect and venous blood gas alterations during Intravenous Regional Anesthesia with Lidocaine
This study will be performed by the aim of comparison the analgesia and venous blood gas alterations by adding Paracetamol or Magnesium Sulphate to Lidocaine in upper extremity surgeries under intravenous regional anesthesia as a double blinded clinical trial with placebo. Ninety ASA class I, II patients between 15 to 65 years divided into 3 groups of 30 cases. Allergic reaction to Lidocaine, Acetaminophen or Magnesium sulphate is the main exclusion criterion. Group 1(control) will receive 3 mg/kg Lidocaine 0.5% plus Saline IV by the volume of 40 ml. Group 2(Magnesium Sulphate) will get 3 mg/kg Lidocaine 0.5% plus 10 ml Magnesium Sulphate 15% and Saline IV by the volume of 40 ml. Group 3(Paracetamol) will have 3 mg/kg Lidocaine 0.5% plus 300 mg Paracetamol and Saline IV by the volume of 40 ml. Sensory block evaluation will be done by pinprick and motor block by inability to move the extremity which will be assessed every 30 seconds. Visual Analog scale is used for measure pain sensation. If tourniquet pain produces VAS =4 or more, 1 mic/kg Fentanyl will be injected. Venous PH, PO2 and PCO2 at the beginning and before deflation of tourniquet will be measured. At the first time after operation by VAS=4, 2 mg of Morphine IV will be given every 15 minutes to decrease the score to 3 or less. Total dose of Morphine and VAS, BP, HR and SPO2 will be assessed during 24 hour
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112254046N2
Registration date:2012-01-08, 1390/10/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-01-08, 1390/10/18
Registrant information
Name
Alireza Mirkheshti
Name of organization / entity
Shahid Beheshti university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 21 7755 8081
Email address
a_mirkheshti@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2011-12-03, 1390/09/12
Expected recruitment end date
2012-03-18, 1390/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between magnesium sulfate and paracetamol in Analgesic effect and venous blood gas alterations during Intravenous Regional Anesthesia with Lidocaine
Public title
Comparison between Magnesium sulphate and Paracetamol in intravenous regional anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. Age between 15 to 65 years
2. Appropriate general condition as American Society of Anesthesiologist (ASA) class I and II
3. Upper extremity surgeries
4. Operation time less than 2 hours
Exclusion criteria:
1. Any allergic reaction to Lidocaine, Acetaminophen or Magnesium Sulphate
2. Any cyanosis in affected limb
3.Any opioid or psychoactive drug abuse
Age
From 15 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
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
ُShahid Beheshti University of Medical Sciences
Street address
Velenjak street
City
Tehran
Postal code
1985717443
Approval date
2011-02-27, 1389/12/08
Ethics committee reference number
89-01-148-7489-1
Health conditions studied
1
Description of health condition studied
local anesthetics
ICD-10 code
Y48.3
ICD-10 code description
Anesthesia-regional
Primary outcomes
1
Description
Sensory block
Timepoint
During and after operation
Method of measurement
Pinprick test
2
Description
Motor block
Timepoint
During and after operation
Method of measurement
Remove of all hand movements
3
Description
Venous blood gas
Timepoint
Before and after procedure
Method of measurement
Venous blood sample
4
Description
Pain
Timepoint
During the operation and 24 hours after that
Method of measurement
Visual Analog Scale
Secondary outcomes
1
Description
Saturation of oxygen
Timepoint
Durig operation and 24 hours after that
Method of measurement
Pulse oximetery
2
Description
Blood pressure
Timepoint
During operation and 24 hours after that
Method of measurement
Blood pressure manometer
3
Description
Heart rate
Timepoint
During operation and 24 hours after that
Method of measurement
Pulse oximetery
Intervention groups
1
Description
Control group:they will receive Lidocaine 0.5% , 3 mg/kg plus normal saline intravenousely by the total volume of 40 ml .
Category
Treatment - Drugs
2
Description
Magnesium Sulphate ( intervention) group:they will receive Lidocaine 0.5%, 3 mg/kg plus magnesium sulphate 15%, 10 ml (Magnesium Sulphate 20% Hypertonic, made by Pastor Institude-iran)and normal saline intravenousely by the total volume of 40 ml.
Category
Treatment - Drugs
3
Description
Paracetamol(intervention) group:they will receive Lidocaine 0.5%, 3 mg/kg plus Paracetamol (Apotel,made by Unipharma, Greece) 1000 mg and normal saline intravenousely by the total volume of 40 ml.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein hospital
Full name of responsible person
Alireza Mirkheshti MD
Street address
Shahid Madani street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Anesthesiology research center,Shahid Beheshti University of Medical Sciences
Full name of responsible person
Taheri
Street address
Ayatollah Taleghani Hospital- Velenjak Ave.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Anesthesiology research center,Shahid Beheshti 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
Anesthesiology research center-Shahid Beheshti University ,M.C
Full name of responsible person
Mrs.Taheri
Position
Official clerk
Other areas of specialty/work
Street address
Velenjak street-Taleghani hospital
City
Tehran
Postal code
Phone
+98 21 2243 2572
Fax
Email
a.r.c@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Imam Hossein Hospital
Full name of responsible person
Alireza Mirkheshti MD
Position
Assistant professor of Anesthesiology
Other areas of specialty/work
Street address
Shahid Madani street
City
Tehran
Postal code
1617763141
Phone
+98 21 7756 7840
Fax
Email
a_mirkheshti@sbmu.ac.ir; alimirkheshti@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Imam Hossein Hospital
Full name of responsible person
Alireza Mirkheshti MD.
Position
Assistant professor of anesthesiology
Other areas of specialty/work
Street address
Shahid Madani street
City
Tehran
Postal code
1617763141
Phone
+98 21 7756 7840
Fax
Email
a_mirkheshti@sbmu.ac.ir; alimirkheshti@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)