Comparison of the effect of lavender and rosemary extract on sore throat and Hoarseness caused by endotracheal intubation in patients after Percutaneous Nephrolithotomy
Comparison of the effect of lavender and rosemary extract on sore throat and Hoarseness caused by endotracheal intubation in patients after Percutaneous Nephrolithotomy.
Design
The present study is a randomized clinical trial with control group, with parallel groups, single blind and third phase on 90 Patients who have inclusion criteria that are divided into three groups of treatment with lavender and rosemary extracts and the control group with randomized block method.
Settings and conduct
This study is performed in the urology operating room of Kerman Bahonar Hospital. For men, a tracheal tube with a size (7.5-8) and for women (7.5-7) is used. Also, for all patients, a brand of endotracheal tube is used. A sterile gas impregnated with the studied fluid is inserted into the patient's throat by forceps. These gases are prepared by the relevant anesthesia nurse who entered during the investigation. So that the gases of the intervention groups are impregnated in one group with 3 cc of rosemary syrup with a concentration of 0.5% and the other group with 3 cc of lavender with a concentration of 0.5%; The gases of the control group are also impregnated with 3 cc of distilled water. And patients are transferred to the recovery unit. After the patient awarness, using a VAS scale and a questionnaire related to voice violence by an anesthesia student who was unaware of the grouping, the patient sore throat and voice violence were measured and recorded in recovery 2-6-and24 hours after the patient's extubation.
Participants/Inclusion and exclusion criteria
patients undergoing intubation and located in prone positions
Intervention groups
rosemary group-lavender group-control group
Main outcome variables
sore throat- hoarsness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211124053172N2
Registration date:2022-01-09, 1400/10/19
Registration timing:registered_while_recruiting
Last update:2022-01-09, 1400/10/19
Update count:0
Registration date
2022-01-09, 1400/10/19
Registrant information
Name
Atena Samareh Fekri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3211 3491
Email address
atena.samarehfekri@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2022-04-21, 1401/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of lavender and rosemary extract on sore throat and Hoarseness caused by endotracheal intubation in patients after Percutaneous Nephrolithotomy
Public title
evaluation of the effect of lavender and rosemary extract on sore throat and Hoarseness caused by endotracheal intubation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
age more than 18 year
Percutaneous Nephrolithotomy candidate undergoing general anesthesia in prone position
ability of communicating and responding to questions
using the same brand of endotracheal tube
endotracheal size 7.5-8 for men and 7-7.5 for women
Mallampati degree 1 and 2
ASA class 1 and 2
Exclusion criteria:
history of sore throat
abnormal airway
suffering from upper airway infection and respiratory disease like sinusitis, asthma and chronic obstructive disease
sensitivity history of lavender and rosemary
consumption of anti inflammatory medication over past 2 weeks
drug addiction
psychopathic
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Patients who met the inclusion criteria were selected by available sampling method and randomly divided into three groups of aromatherapy with lavender, rosemary and control. To compile a random list, the online software https://www.sealedenvelope.com/simple-randomiser/v1/lists will be used, the size of the blocks will be 6 and the two variables (gender / male) and age ( Less than 30 years old) will be considered as classes when creating a random list.
Blinding (investigator's opinion)
Single blinded
Blinding description
After being alert and ensuring the patient's ability to communicate in recovery, using the VAS scale and a questionnaire related to voice violence by an anesthesia student who was unaware of the grouping, measures and records sore throat and patient voice violence in recovery 2-6-24hours later.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of kerman university of medical sciences
Intervention group: After intubation, a sterile gauze impregnated with the studied fluid is placed in the patient's throat with forceps. So that the gases of the intervention groups are impregnated with 3 cc of rosemary syrup with a concentration of 0.5% of Gol Daroo manufacturer.
Category
Prevention
2
Description
Intervention group: After intubation, a sterile gauze impregnated with the studied fluid is placed in the patient's throat with forceps. So that the gases of the intervention groups are impregnated with 3 cc of lavender syrup with a concentration of 0.5% of Gol Daroo manufacturer.
Category
Prevention
3
Description
Control group: The gases of control group are impregnated with normal saline.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Bahonar hospital
Full name of responsible person
Atena Samarehfekri
Street address
NO.22 Alley 13 .jomhouri BLV
City
Kerman
Province
Kerman
Postal code
7618738577
Phone
+98 34 3211 3491
Email
atena.samarehfekri@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhti
Street address
The Beginning of Haft Bagh Highway
City
Kerman
Province
Kerman
Postal code
7618738577
Phone
+98 34 3132 5050
Email
abpardakhty@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Atena Samareh Fekri
Position
Employee of Kerman University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No.22 , Alley 13 ,Jomhouri BLV
City
Kerman
Province
Kerman
Postal code
7618738577
Phone
+98 34 3211 3491
Email
atena.samarehfekri@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Atena Samareh Fekri
Position
Employee of Kerman University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No.22 , Alley 13 , Jomhouri BLV
City
Kerman
Province
Kerman
Postal code
7618738577
Phone
+98 34 3211 3491
Email
atena.samarehfekri@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Atena Samareh Fekri
Position
University employee
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No 22 , Blv jomhouri 13
City
Kerman
Province
Kerman
Postal code
7618738577
Phone
+98 34 3211 3491
Fax
Email
atena.samarehfekri@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