Comparison of pain on propofol injection by propofol diluted with patient blood, propofol mixed with 0.05lidocaine and propofol diluted with normal saline in patients undergoing surgery
Propofol is one of the ideal drugs for anesthesia in most patients undergoing surgery. One of its complications is the pain produced at the time of injection. The aim of this study is to comparison of pain on propofol injection by propofol diluted with patient blood, propofol mixed with 0.05 lidocaine and propofol diluted with normal saline in patients undergoing surgery. This study is a randomized double-blind clinical trial, in which 120 patients undergoing
elective surgery with ASA class one and two will enrolled. Three groups of patients had injections as follows:
In the first group Propofol will diluted with patient blood, in second group, propofol mixed with 0.05 lidocaine, and in third group, propofol diluted with normal saline and will injecte. Venous catheter 14 gauge will used in all cases for injection, then BP, P, and pain intensity will measured by VRS (Verbal Rating Scale) criteria.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201401013912N6
Registration date:2015-08-17, 1394/05/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-08-17, 1394/05/26
Registrant information
Name
Kobra Nourian
Name of organization / entity
Sharekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1333 5648
Email address
noorian@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrekord University of Medical Sciences
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2015-09-23, 1394/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of pain on propofol injection by propofol diluted with patient blood, propofol mixed with 0.05lidocaine and propofol diluted with normal saline in patients undergoing surgery
Public title
pain during Propofol injection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: The patients aged 20 to 60 years who are candidate for elective surgery; ASA class one and two. Exclusion criteria: use of Hypnotic, narcotics or analgesic drugs before surgery; addicted to opioids; alcoholism; hypersensitivity to xylocaine, propofol and eggs; patients with chronic pain syndrome; Thrombophlebitis; sedated and not being able to communicate verbally.
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:
120
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
Shahrekord University of Medical Sciences
Street address
Shahrekord University of Medical Sciences, Kashani Street
City
Shahrekord
Postal code
Approval date
2014-09-06, 1393/06/15
Ethics committee reference number
1053
Health conditions studied
1
Description of health condition studied
pain of propofol injection
ICD-10 code
Y48.2
ICD-10 code description
Other and unspecified general anaesthetics
Primary outcomes
1
Description
Blood Pressure
Timepoint
Just before, after injection, and after record of pain
Method of measurement
mmhg by sphegmomanometer
2
Description
Pulse
Timepoint
Just before, after injection, and after record of pain
Method of measurement
beat per minute/Radial artery
3
Description
Pain
Timepoint
Just before, and after injection, and after record of pain
Method of measurement
VRS
Secondary outcomes
empty
Intervention groups
1
Description
In the first group Propofol will be diluted with patient blood, and then will be injected.
Category
Treatment - Drugs
2
Description
In second group, propofol mixed with 0.05 lidocaine, and then will be injected.
Category
Treatment - Drugs
3
Description
In third group, propofol diluted with normal saline, and then will be injected.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani Hospital
Full name of responsible person
Kobra Noorian
Street address
Kashani Haspital,Parastar Street.
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Dr Mohammad Mobasheri
Street address
Vice chancellor for research & technology, Kashani Street.
City
Shahrekord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahrekord 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
Shahrekord University of Medical Sciences
Full name of responsible person
Kobra Noorian
Position
Instructor
Other areas of specialty/work
Street address
Shahrekord University of Medical Sciences, Kashani Street
City
Shahrekord
Postal code
Phone
+98 38333335648
Fax
Email
Nooriandehkordy@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Kobra Noorian
Position
Instructor
Other areas of specialty/work
Street address
Kashani Street, Shahrekord University of Medical Sciences
City
Shahrekord
Postal code
Phone
+98 38333335648
Fax
Email
Nooriadehkordy@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Kobra Noorian
Position
Instructor
Other areas of specialty/work
Street address
Parastar street, Kashani Hospital
City
Shahrekord
Postal code
Phone
+98 38333335648
Fax
Email
Nooriandehkordy@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)