comparative assessment of applying beclomethasone spray and fluticasone spray on endotracheal tube cuff on postoperative sore throat in elective surgery patients
The main objective of this study is comparing the effects of applying beclomethasone and fluticasone spray on endotracheal tube cuff on postoperative sore throat. This is a clinical trial on 90 patients who are selected for elective surgeries. Inclusion criteria: age 18 to 65 year; ASA classification of I and II; having no airway problem. Exclusion criteria: patients who may be traumatized during intubation; more than two times of trying for intubation; patients who need Succinylcholine injection. The patients will be divided into three following groups randomly: 1. Beclomethasone (200µg) spray is applied on the cuff of endotracheal tube (ETT) before intubation. 2. Fluticasone (200µg) spray is applied on the cuff of endotracheal tube (ETT) before intubation. 3. Normal saline is applied on the cuff of ETT before intubation. After induction of anesthesia, intubation is performed gently and this is done by a fixed person. After intubation cuff inflation is performed using Minimal Leak Technique. During operation we never manipulate ETT's cuff. In hours 1 and 24 after surgery, one who is blind to the study assesses the patients for sore throat. The severity of sore throat is determined according to VAS score and comparison is performed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013012812007N2
Registration date:2014-05-29, 1393/03/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-05-29, 1393/03/08
Registrant information
Name
Mohammad Reza Doroudian
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1246 2055
Email address
mdoroudian@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Kerman University of Medical Sciences
Expected recruitment start date
2014-04-01, 1393/01/12
Expected recruitment end date
2014-08-02, 1393/05/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparative assessment of applying beclomethasone spray and fluticasone spray on endotracheal tube cuff on postoperative sore throat in elective surgery patients
Public title
assessment of applying beclomethasone spray and fluticasone spray on endotracheal tube cuff on postoperative sore throat
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age 18 to 65 year; ASA classification of I and II; having no airway problem. Exclusion criteria: patients who may be traumatized during intubation; more than two times of trying for intubation; patients who need Succinylcholine injection; taking steroid therapy; head and neck or oral surgeries; laryngoscopy time more than 15 second; patients who take analgesics for 24 hours postoperatively.
Age
From 17 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Informed consent is obtained from all subjects or their proxy and their rejection has no effect on normal treatment path. All intubations are performed by a same person who is blind to applied medication. The method of anesthesia in all is similar. Randomization is done by draw.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kerman University Medical Sciences
Street address
Shafa Square
City
Kerman
Postal code
Approval date
2014-02-03, 1392/11/14
Ethics committee reference number
K/92/578
Health conditions studied
1
Description of health condition studied
Relation of applying beclomethasone spray and fluticasone spray on endotracheal tube cuff with postoperative sore throat in patient with surgery
ICD-10 code
J02.9
ICD-10 code description
Acute pharyngitis, unspecified
Primary outcomes
1
Description
sore throat
Timepoint
1 and 24 hours after surgery
Method of measurement
VAS score
Secondary outcomes
empty
Intervention groups
1
Description
Fluticasone (200µg) spray is applied on the cuff of endotracheal tube (ETT) before intubation (flucitasone 0.05 percent or 50 mcg fluticasone in each puff made by RAHA pharmaceutical Co.)
Category
Treatment - Drugs
2
Description
Beclomethasone (200µg) spray is applied on the cuff of endotracheal tube (ETT) before intubation (Beclomethasone Dipropionate, spray, dose 50 µg\puff, brand CLENIL, producer SINA DAROU LAB, quantity 200 puff)
Category
Treatment - Drugs
3
Description
Normal saline is applied on the cuff of ETT before intubation
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bahonar Hospital
Full name of responsible person
Bahareh Mirzaee
Street address
Baghemelli Square
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Hassani
Street address
Tahmasbabad Square, Ebnesina Street
City
Kerman
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
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
Kerman University of Medical Sciences
Full name of responsible person
Bahareh Mirzaii
Position
َAssistant of anesthesiology
Other areas of specialty/work
Street address
Afzalipoor Hospital
City
Kerman
Postal code
Phone
+98 34 1322 2250
Fax
Email
bahar8700@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mohammad Reza Doroudian
Position
Anesthesiologist
Other areas of specialty/work
Street address
Bahonar Hospital
City
Kerman
Postal code
Phone
+98 34 1223 5011
Fax
Email
javadkordi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Bahareh Mirzaee
Position
Assistant of anesthesiology
Other areas of specialty/work
Street address
Baghemelli Square, Bahonar hospital
City
Kerman
Postal code
Phone
+98 34 1223 5011
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)