Effect of rosemary herbal remedy on sore throat after general anesthesia with tracheal intubation
Design
Clinical trial with control group, with parallel, double-blind, randomized
Settings and conduct
Emam reza hospital
Patients will be divided to 2 groups by VAS method; study and control groups after signing informed consent for controlling of sore throat due to surgery. In study group an sterilized gauze impregnated with 10 cc of Rosemary herbal extract, packaged in the patient's throat, followed by intubation. Surgeon and anesthesia specialized will be blind to study. In control group the drug won't be given. The sore throat severity will be measured by VAS in the recovery first and then it will be repeated 2-6-24 hours after consciousness. The data will be analyzed by descriptive statistic methods, mean different tests for independent groups and by frequent measurements of RMA test, chi square test, SPSS15 statistic software. P<0.05 will be sensitive statistically. The normality of data will be measured by Q-Q curve and Smirnov-Klomologrov test.
Participants/Inclusion and exclusion criteria
Inclusion criteria: all 20-60 years old patients candid for urologic surgery; ASA I-II; intubation in the position of lying on back. Exclusion criteria: NSAIDs use in 2 weeks before surgery; the history of sore throat and upper respiratory tract infections; difficult intubation; long time surgery over than 3 hours; drug reaction; addiction; psychopathic conditions; emergency patients; pregnant patients
Intervention groups
In the study group, sterilized gauze impregnated with 10 cc of Rosemary herbal extract, packaged in the patient's throat, followed by intubation and the use of placebo, an sterilized gauze impregnated with distilled water in the control group
Main outcome variables
The sore throat severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180806040724N1
Registration date:2018-09-09, 1397/06/18
Registration timing:retrospective
Last update:2018-09-09, 1397/06/18
Update count:0
Registration date
2018-09-09, 1397/06/18
Registrant information
Name
Abbasali Dehgan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3336 6777
Email address
dehghania@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-15, 1397/05/24
Expected recruitment end date
2018-09-05, 1397/06/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Rosemary on sore throat after general anesthesia with tracheal intubation
Public title
Effect of Rosemary on sore throat after general anesthesia with tracheal intubation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All 20-60 years old patients candid for surgery
ASA I-II
Intubation in the position of lying on back.
Exclusion criteria:
NSAIDs use in 2 weeks before surgery
The history of sore throat and upper respiratory tract infections
Difficult intubation
Long time surgery over than 3 hours
Drug reaction
Addiction
Psychopathic conditions
Emergency patients
Pregnant patients
Age
From 19 years old to 59 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Randomly permuted block
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, researchers, evaluated patients after obtaining, informed consent and the outcome of the treatment (placebo and study) and how to divide patients into two groups (study and control) are blind
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Daneshgah Ave., Azadi Blvd., Tabriz Town
City
Tabriz
Province
East Azarbaijan
Postal code
51588-93895
Approval date
2018-06-10, 1397/03/20
Ethics committee reference number
IR.TBZMED.REC.1397.252
Health conditions studied
1
Description of health condition studied
Sore throat after extubation in general anesthia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The sore throat severity
Timepoint
Two, 6 and 24 hours after recovery
Method of measurement
Visual Analogue Scale(VAS)
Secondary outcomes
1
Description
The side effect of ROSEMARY
Timepoint
Daily
Method of measurement
Graded questionnaire
Intervention groups
1
Description
Intervention group: the study group, sterilized gauze impregnated with 10 cc of Rosemary herbal extract, packaged in the patient's throat, followed by intubation.
Category
Treatment - Drugs
2
Description
Control group: Use of placebo, an sterilized gauze impregnated with distilled water in the control group
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam reza hospital
Full name of responsible person
Dr abbas ali dehghani
Street address
Daneshgah Ave., Azadi Blvd., Tabriz Town
City
Tabriz
Province
East Azarbaijan
Postal code
51588-93895
Phone
+98 41 3334 7054
Email
vnajd228@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr atta mohammadpour
Street address
Daneshgah Ave., Azadi Blvd., Tabriz Town
City
Tabriz
Province
East Azarbaijan
Postal code
51588-93895
Phone
+98 41 3336 4667
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr abbas ali dehghani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Daneshgah Ave., Azadi Blvd., Tabriz Town
City
Tabriz
Province
East Azarbaijan
Postal code
51588-93895
Phone
+98 41 3334 7054
Email
vnajd228@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr abbas ali dehghani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Daneshgah Ave., Azadi Blvd., Tabriz Town
City
Tabriz
Province
East Azarbaijan
Postal code
51588-93895
Phone
+98 41 3334 7054
Email
vnajd228@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr abbas ali dehghani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Daneshgah Ave., Azadi Blvd., Tabriz Town
City
Tabriz
Province
East Azarbaijan
Postal code
51588-93895
Phone
+98 41 3334 7054
Email
vnajd228@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available