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Comparison of effect of intravenous administration of Lidocaine-Fentanyl and lidocaine on reduction of propofol induced pain during intravenous injection

Protocol summary

Summary
In this study, it is attempted to evaluate the effect of two drugs ,Lidocaine and Fentanyl, as combination, comparing to Lidocaine alone on reduction of Propofol venous injection induced pain. This study is a double- blinded clinical trial that was conducted on 150 patients who were waiting for the general anaesthesia. The patients were divided into three separated groups. Inclusion criteria: 16-74 years of age, no history of any cardiovascular disease , autoimmune disease and diabetes. Exclusion Criteria: receiving of analgesics and sedative drugs 24 hours prior to surgery, any drug allergy, neurologic and/or psychologic disease, drug addicts, pregnant women, patients requiring rapid induction of anaesthesia. In each of the three groups, the venous blood flow of the desired hand was blocked via a tourniquet at elbow site. In the first group, 5cc of normal saline 0.9% , in the second group 40mg of Lidocaine +50 μg Fentanyl (diluted to 5cc) and in the third group , 40 mg Lidocaine (diluted to 5cc) were injected.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016051215281N9
Registration date: 2017-01-11, 1395/10/22
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-01-11, 1395/10/22
Registrant information
Name
Seyedebrahim Sadeghi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 4333 3278
Email address
esadeghi@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Shiraz University of Medical Sciences
Expected recruitment start date
2013-06-22, 1392/04/01
Expected recruitment end date
2015-02-20, 1393/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effect of intravenous administration of Lidocaine-Fentanyl and lidocaine on reduction of propofol induced pain during intravenous injection
Public title
Comparison of effect of intravenous administration of Lidocaine-Fentanyl and lidocaine on reduction of propofol induced pain during intravenous injection
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: patients should be 16-74 years of age, they shouldn't have any cardiovascular, autoimmune disease and diabetes. Exclusion Criteria: patients who received sedative drugs 24 hours prior to surgery, any drug allergy, neurologic and/or psychologic disease, drug addicts, pregnant women,patients requiring rapid induction of anesthesia.
Age
From 15 years old to 74 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
randomised via following website: www.random.org

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Zand st., Shiraz Medical University of Shiraz
City
Shiraz
Postal code
Approval date
2015-05-17, 1394/02/27
Ethics committee reference number
IR.SUMS.REC.1394.29

Health conditions studied

1

Description of health condition studied
Complication of anaesthesia
ICD-10 code
T88.5
ICD-10 code description
Other complications of anaesthesia

Primary outcomes

1

Description
effect of lidocaine on reduction of propofol induced pain
Timepoint
1 minute after injection of propofol
Method of measurement
questionnaire and defined pain scale

2

Description
Effect of Lidocaine+Fentanyl on reduction of propofol induced pain
Timepoint
1 minute after injection of propofol
Method of measurement
Questionnaire and defined pain scale

Secondary outcomes

empty

Intervention groups

1

Description
control group: 5cc of normal saline 0.9%,one minute before induction dose of propofol was injected. Propofol lipuro braun Germany
Category
Treatment - Drugs

2

Description
Interventional group: second group 40mg of Lidocaine +50 μg Fentanyl (diluted to 5cc), one minute before injection of induction dose of propofol. Lidocaine Iran hormone- Iran Fentanyl Aburaihan-Iran
Category
Treatment - Drugs

3

Description
Interventional group: Third group 40 mg Lidocaine (diluted to 5cc), one minute before injection of induction dose of propofol
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Motahari hospital of Marvdasht, Iran
Full name of responsible person
Seyed Ebrahim Sadeghi
Street address
City
Marvdasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for International branch of Shiraz Medical Sciences
Full name of responsible person
Dr. Kazem Samadi
Street address
Sadra, International branch of Shiraz Medical Sciences
City
Shiraz
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for International branch of Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Seyed Ebrahim Sadeghi
Position
Anesthesiologist-Assistant Professor
Other areas of specialty/work
Street address
Shahid Motahari Hospital of Marvdasht
City
Marvdasht
Postal code
Phone
+98 71 4333 3278
Fax
Email
esadeghi@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Seyed Ebrahim Sadeghi
Position
Anesthesiologist- Assistant Professor
Other areas of specialty/work
Street address
Shahid Motahari Hospital of Marvdasht
City
Marvdasht
Postal code
Phone
+98 71 4333 3278
Fax
Email
esadeghi@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Seyed Ebrahim Sadeghi
Position
Anesthesiologist- Assistant Professor
Other areas of specialty/work
Street address
Motahari Hospital of Marvdasht
City
Marvdasht
Postal code
Phone
+98 71 4333 3278
Fax
Email
esadeghi@sums.ac.ir
Web page address

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
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