Effects of intracuff dexamethasone, intravenous dexamethasone & application of bethametasone ointment on endotracheal tube cuff on Post-intubation sore throat
Sorethroat is a common problem after general anesthesia. It may be seen after using tracheal tube, laryngeal mask air way or even anesthesia face mask. In this study the efficacy of intracuff dexamethasone, intravenous dexamethasone & lubricating cuff & distal end of tracheal tube with betametasone ointment on sorethroat are compared.A total of 120 patients, American Society of Anesthesiologists (ASA) class 1 – 2, scheduled for elective abdominal or orthopedic operations under general anesthesia are enrolled in this double blind clinical trial study. All the patients are randomly allocated to four groups: the endotracheal tube cuffs of the patients in the first group are filled with 16 mg dexamethasone. Patients in the second group receive 8 mg dexamethasone intravenously. In the third group cuff and distal end of the endotracheal tubes are lubricated with betamethasone ointment and in the fourth group cuffs are filled with air as usual. Frequency of sore throat and its intensity on a visual analog scale (VAS) are assessed in each group after recovery period and 8 and 24 hours after that. The data are transferred to SPSS 18 software and analyzed statically with chi-square and ANOVA tests.
P value less than 0.05 is considered significant.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201302178531N2
Registration date:2013-03-07, 1391/12/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-03-07, 1391/12/17
Registrant information
Name
Ladan Ansari
Name of organization / entity
Islamic Azad University, Tehran Medical Branch
Country
Iran (Islamic Republic of)
Phone
+98 21 8876 4030
Email address
lansari@iautmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Islamic Azad University - Tehran Medical Branch
Expected recruitment start date
2009-08-06, 1388/05/15
Expected recruitment end date
2010-08-06, 1389/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of intracuff dexamethasone, intravenous dexamethasone & application of bethametasone ointment on endotracheal tube cuff on Post-intubation sore throat
Public title
Effects of intracuff dexamethasone, intravenous dexamethasone & application of bethametasone ointment on endotracheal tube cuff on Post-intubation sore throat
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 60>age>18 yr; ASA class 1 or 2; no URI infection or sorethroat at the time of surgery; no possibility of difficult air way; no candidate of surgery on air way; candidate of general anesthesia & tracheal intubation; no contraindication for receiving steroids.
Exclusion criteria: intraoperation pharyngeal packing; intraoperation NG tube placement.
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
120
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
Ethics committee of Tehran Medical Branch of Islamic Azad University
Street address
Islamic Azad University - Tehran Medical Branch, Khaghani st.
City
Tehran
Postal code
Approval date
2009-08-05, 1388/05/14
Ethics committee reference number
13610101861085
Health conditions studied
1
Description of health condition studied
prevention of sore throat after tracheal intubation
ICD-10 code
Y70
ICD-10 code description
Anaesthesiology devices associated with adverse incidents
Primary outcomes
1
Description
sore throat after tracheal intubation
Timepoint
After recovery period, 8 & 24 hours after intervention
Method of measurement
Questionaire & VAS method
Secondary outcomes
empty
Intervention groups
1
Description
First group: Intracuff application of 16 mg dexamethasone.
Category
Prevention
2
Description
Third group: application of bethametasone ointment on endotracheal tube cuff.
Category
Prevention
3
Description
Second group: Intravenous application of 8 mg dexamethasone.
Category
Prevention
4
Description
Fourth group or control group: filling the endotracheal tube cuff with air.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Booali hospital
Full name of responsible person
Ladan Ansari
Street address
Damavand st.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ladan Ansari
Full name of responsible person
Ladan Ansari
Street address
N.1 - 26 Alley, Dr. Ghandi st., North Sohrevardi st.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ladan Ansari
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Islamic Azad University, Tehran Medical Branch, Vice chansellor for research
Full name of responsible person
Dr. Seyedshahabedin Mohseni
Street address
Islamic Azad University,Tehran Medical Branch, Zargande, Shariati ST.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University, Tehran Medical Branch, Vice chansellor for research
Proportion provided by this source
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
Tehran Medical Branch of Islamic Azad University
Full name of responsible person
Ladan Ansari
Position
Professor assistant of anesthesiology
Other areas of specialty/work
Street address
N.1 - 26 Alley, Dr. Ghandi st., North Sohrevardi st.
City
Tehran
Postal code
Phone
+98 21 8876 4030
Fax
Email
Ladanansari46@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran Medical Branch of Islamic Azad University
Full name of responsible person
Ladan ansari
Position
Assistant professor of anesthesiology
Other areas of specialty/work
Street address
N.1 - 26 Alley, Dr. Ghandi st., North Sohrevardi st.
City
Tehran
Postal code
Phone
+98 21 8876 4030
Fax
Email
Ladanansari46@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran Medical Branch of Islamic Azad University
Full name of responsible person
Ladan ansari
Position
Professor assistant of anesthesiology
Other areas of specialty/work
Street address
N.1 - 26 Alley, Dr. Ghandi st., North Sohrevardi st.
City
Tehran
Postal code
Phone
+98 21 8876 4030
Fax
Email
Ladanansari46@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)