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Evaluation The effect of Eucalyptus flavoured candy on the severity of sore throat, cough, and hoarseness due to intubation after anesthesia in orthopedic surgery in Shahrood city

Protocol summary

Summary
The present study is a randomized clinical trial. The aim of this study was to determine the effect of Eucalyptus flavored candy on the severity of sore throat, cough, and hoarseness caused by tracheal intubation in anesthesia of open end surgery in patients referred to Imam Hossein Hospital in Shahrud in 1396. In this study, 134 patients from the populationof this study that aged between 18-60 years old and ASA class 1 and 2 anesthesia who did not have a history of sore throat, cough, and hoarseness before surgery were divided into two groups of candy recipients and routine care. Patients with difficulty intubating, prolonging surgery for more than 2 hours, spasticity and the need for steroids are excluded from study. the eucalyptus candy will be given to the intervention group, half an hour before the surgery, and intervals of 2, 6, 12, 18, and 24 hours after the end of the surgery, and sore throats, coughs, and hoarseness of all patients will be examined 2, 6, 12, and 24 hours after Surgery (and 15 minutes after receiving candy). Due to the effects of candy, the outcome of this study is to provide a suitable treatment for preventing and reducing the complications after the anesthetic process.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017072335252N1
Registration date: 2017-08-21, 1396/05/30
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-08-21, 1396/05/30
Registrant information
Name
Solmaz Nazmara
Name of organization / entity
Sabzevar University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 4401 1000
Email address
nazmaras94@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Sabzevar Univesrity of Medical Sciences
Expected recruitment start date
2017-08-11, 1396/05/20
Expected recruitment end date
2017-12-11, 1396/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation The effect of Eucalyptus flavoured candy on the severity of sore throat, cough, and hoarseness due to intubation after anesthesia in orthopedic surgery in Shahrood city
Public title
The effect of Eucalyptus candy on sore throat, cough, and hoarseness in surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion:Patients with ASA class 1 & 2 anesthesia; no sore throat, cough or hoarseness before surgery; age between 18-60 years; Patients undergoing open orthopedic surgeries (end organ surgery); no addiction; duration from 30 to 120 minutes exclusion criteria:The need for more than one attempt to intubation; Longer time of surgery for more than 2 hours; airway spasm at the end of anesthesia; history of receiving steroids and opiates during a week before surgery
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 134
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Sabzevar University of Medical Sciences
Street address
Tohid Shahr - Paradise of the University of Medical Sciences
City
Sabzevar
Postal code
9613873136
Approval date
2017-07-16, 1396/04/25
Ethics committee reference number
ir.medsab.rec.1396.32

Health conditions studied

1

Description of health condition studied
complication of intubation
ICD-10 code
y70
ICD-10 code description
Anaesthesiology devices associated with adverse incidents

Primary outcomes

1

Description
sore throat
Timepoint
2, 6, 12 and 24 hours after extubation
Method of measurement
Visual Analog Scale

2

Description
cough
Timepoint
At recovery, 2, 6, 12 and 24 hours after extubation
Method of measurement
Asking and viewing

3

Description
hoarseness
Timepoint
2, 6, 12 and 24 hours after extubation
Method of measurement
Asking and viewing

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:Five eucalyptus candy flavors will be given orally to the intervention group (first candy, half an hour before anesthesia and the rest of the candy, 6, 12, 18, and 24 hours after the end of the extubation)
Category
Prevention

2

Description
Control group: In this group, routine therapies are used, and only the variables are measured at specific times.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Hossein Shahroud Hospital
Full name of responsible person
Dr Javad Noorian
Street address
Imam Street, at the end of 28 meters
City
Shahroud

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Dr Mohammadzadeh
Street address
Tohid Shahr - University of Medical Sciences
City
Sabzevar
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Javad Ganjloo
Position
Master / Clinical Faculty member
Other areas of specialty/work
Street address
Towhid City - Sabzevar University of Medical Sciences
City
Sabzevar
Postal code
9613873136
Phone
+98 51 4426 4462
Fax
+98 51 4401 8356
Email
jganj@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Javad Ganjloo
Position
Master of nursing
Other areas of specialty/work
Street address
Tohid Shahr - University of Medical Sciences
City
Sabzevar
Postal code
9613873136
Phone
+98 51 4401 8356
Fax
+98 51 4401 8356
Email
jganj@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Solmaz Nazmara
Position
Bachelor of Nursing / Master of Nursing Student
Other areas of specialty/work
Street address
ٍEdalat Street 6 - Unit 4
City
Shahroud
Postal code
Phone
+98 23 3236 9357
Fax
Email
nazmaras94@medsab.ac.irsnazmara2015or@gmail.com
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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