our aim in this study is the evaluating the effect of pregabalin on post tracheal intubation sore throat after general surgery.this is a double blind and randomized clinical trial.in this study sixty patients candidate for urologic and general surgery will be included in the study after qualifying the inclusion and exclusion criteria and obtaining the informed consent.Iclusion criteria:all 20-60 years patient candidate for urologic and general surgery.Exclusion criteria:1-NSAIDs intake in two week before surgery
2-history of sore throat and upper respiratory tract infection3-difficult intubation4-long surgery time more than 3 hours5-drug allergy6-addiction7-psychotic patient8-defective positionpatients will be divided to two group of thirty(A,B).A group patients will recieve a lyrica tab 300 mg and B group patients will recieve placebo one hour before intubation. patients will be extubated at the end of surgery.sore throat severity will be measured with VAS at 2,6,24 hour after consiousness by a person who was unaware about grouping.data will be analyzed by descriptive statistic test,mean difference test for indeppendent group, frequent measurment RMA test,chi-square test with spss 15 statistic soft ware. p<0.05 will be significantly.data normality will be evaluated by Q-Q wave and colmogrov-smirnov test.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015031416956N4
Registration date:2015-06-22, 1394/04/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-06-22, 1394/04/01
Registrant information
Name
Hassan Mohammadipour Anvari
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 7054
Email address
dr.anvari22@yahoo.com
Recruitment status
Recruitment complete
Funding source
Tabriz university of Medical Sciences
Expected recruitment start date
2015-04-04, 1394/01/15
Expected recruitment end date
2015-07-06, 1394/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect single dose of pregabalin on post tracheal intubation sore throat after general anesthesia
Public title
The effect single dose of pregabalin on post tracheal intubation sore throat after general anesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Iclusion criteria:all 20-60 years patient candidate for urologic and general surgery.Exclusion criteria:1-NSAIDs intake in two week before surgery
2-history of sore throat and upper respiratory tract infection3-difficult intubation4-long surgery time more than 3 hours5-drug allergy6-addiction7-psychotic patient8-defective position
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:
60
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
Tabriz, Azadi street,Golgash street
City
tabriz
Postal code
Approval date
2015-02-15, 1393/11/26
Ethics committee reference number
92/3-4/10
Health conditions studied
1
Description of health condition studied
post tracheal intubation sore throat after general anesthesia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
sore throat
Timepoint
recovery,2,6 and 24 hours after
Method of measurement
VAS
Secondary outcomes
1
Description
vertigo
Timepoint
daily
Method of measurement
graded questionnaire
2
Description
visual disorder
Timepoint
daily
Method of measurement
graded questionnaire
3
Description
oedema
Timepoint
daily
Method of measurement
graded questionnaire
Intervention groups
1
Description
intervention group will receive A pregabalin (lyrica) tab 300 mg with 50 ml water one hour before anesthesia.
Category
Treatment - Drugs
2
Description
control group will receive placebo with 50 ml water
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Dr.Hasan Mohammadi pour Anvari
Street address
City
tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Tabriz Faculty of Medical Sciences
Full name of responsible person
Dr. Hasan Soleimanpour
Street address
Tabriz University of Medical Sciences, Medical Faculty,Vice Chancellor for research
City
Tabriz
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 of Tabriz Faculty 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 Siences
Full name of responsible person
Afsaneh Khobeideh
Position
Medicine student
Other areas of specialty/work
Street address
Tabriz University of Medical Siences,Medical Faculty
City
Tabriz
Postal code
Phone
+98 41 3337 3967
Fax
Email
A_khobeideh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Hasan Mohammadi Pour Anvari
Position
professor assistant
Other areas of specialty/work
Street address
Daneshgah Square,Tabriz University of Medical Sciences
City
Tabriz
Postal code
Phone
+98 413333475455
Fax
Email
Dr.anvari22@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hassan Mohammadipour Anvari
Position
Assistant professor
Other areas of specialty/work
Street address
Emam Reza hospital
City
Tabriz
Postal code
Phone
+98 41 3334 7054
Fax
Email
dr.anvari22@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)