The aim of this study was to compare pretreatment with ephedrine and lidocaine on intensity of pain on injection of propofol and hemodynamic changes. This study was done as a randomized double blind clinical trial in 2009 in Shahid Rajaee hospital. 99 patients, ASA physical status I and II, were randomly assigned into three groups to receive intravenous (IV) lidocaine 40mg, ephedrine 30μg/kg or 2ml saline. After one minute, propofol, 2mg/kg, was injected into a dorsal hand vein. Pain, assessed through face pain scale (FPS), arterial blood pressure, and heart rate were recorded before induction, just before intubation, and one minute after intubation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138812053423N1
Registration date:2010-06-12, 1389/03/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-06-12, 1389/03/22
Registrant information
Name
Hamideh Yari
Name of organization / entity
Qazvin University of Medical Sciences & Health Services
Country
Iran (Islamic Republic of)
Phone
+98 28 1368 5495
Email address
hyari@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Qazvin University of Medical Sciences
Expected recruitment start date
2009-04-21, 1388/02/01
Expected recruitment end date
2009-07-23, 1388/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determination of the low dose ephedrine and lidocaine effect on pain and hemodynamic changes due to propofol injection
Public title
Comparison of ephedrine and lidocaine effects on pain
and blood pressure changes due to propofol injection
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: undergone elective surgery, absence of heart disease, cardiovascular, and neurological and allergic disease, age 20-50.
Exclusion criteria: receiving tranquilizer, opiate or analgesic during 24 hours prior to the intervention, difficulty in communicating with patients, wheal after induction despite no history of allergies, multiple intubation attempts
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
99
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
Qazvin University of Medical Sciences & Health Services
Street address
Shahid Bahonar Blvd. Qazvin
City
Qazvin
Postal code
Approval date
empty
Ethics committee reference number
28/20/2766
Health conditions studied
1
Description of health condition studied
the advantage effects of efedrine on reducing Side effects of propofol
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
pain
Timepoint
one Minute before Intervention,one and three after Intervention
Method of measurement
face pain scale
2
Description
blood pressure chnges
Timepoint
one Minute before Intervention,one and three after Intervention
Method of measurement
blood pressure on the scale mmHg
3
Description
Heart rate
Timepoint
one Minute before Intervention, one and three after the intervention
Method of measurement
Measured by pulse oximetry device on the scale beat per minute
Secondary outcomes
empty
Intervention groups
1
Description
Injection of saline (0/9% ) 2 cc , intravenous (dorsal hand vein) one minute before induction with propofol
Category
Prevention
2
Description
Injection of lidocaine (2% )2 cc , intravenous (dorsal hand vein) one minute before induction with propofol
Category
Prevention
3
Description
Injection of efedrine, 30 microgram per kilogram, intravenous (dorsal hand vein) one minute before induction with propofol
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajaee hospital, Qazvin
Full name of responsible person
Dr. Hamideh Yari
Street address
Padegan st., Qazvin
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Qazvin University of Medical Sciences
Full name of responsible person
Dr. Saeed Asefzadeh
Street address
Shahid Bahonar Blvd. Qazvin
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Qazvin 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
Qazvin University of Medical Sciences & Health Services