Comparing the effectiveness of pre and post intubation injection of dexamethasone in reducing postoperative sore throat in patients candidated for ENT surgery with general anesthesia
70 patients at the age of 30-60 that are candidates for ENT surgery with general anesthesia, will be included in the study. Patients will be divided into two groups randomly. In group A 30 mg dexametasone will be injected intravenously 30 minutes before intubation, and in group B 30 mg dexametasone will be injected intravenously 30 minutes after intubation. One person will intubate all patients and the drug used for anesthesia will be same in both groups. Sore throat and coughing and hoarseness will be studied after 1, 6 and 24 hours after anesthesia. Severity of sore throat and coughing and hoarseness will be measured by using 4-point scale table and compared between two groups considering their age, weight, and duration of intubation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201104272821N4
Registration date:2011-06-11, 1390/03/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-06-11, 1390/03/21
Registrant information
Name
Seyed Javad Seyed Toutounchi
Name of organization / entity
Tabriz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1334 9435
Email address
totonchis@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz university of medical sciences
Expected recruitment start date
2011-04-04, 1390/01/15
Expected recruitment end date
2011-12-06, 1390/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of pre and post intubation injection of dexamethasone in reducing postoperative sore throat in patients candidated for ENT surgery with general anesthesia
Public title
Comparing the effectiveness of pre and post intubation injection of dexamethasone in reducing postoperative sore throat
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: all patients with ENT disease that need to surgery, age between 30-60 years old.
Exclusion criteria: surgery for throat and larynx (tonsils and vocal nodules), upper respiratory infections or sore throat, use of steroid or anti-pain drugs before surgery, change of head position during surgery, patients with NG tube, intubation less than 60 or more than 300 minutes, vomiting during study.
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
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
Tabriz University of Medical Sciences
Street address
Daneshghah Ave
City
Tabriz
Postal code
Approval date
2011-04-05, 1390/01/16
Ethics committee reference number
5/4/255
Health conditions studied
1
Description of health condition studied
sore throat
ICD-10 code
T88
ICD-10 code description
Other complications of surgical and medical care, not elsewhere classified
Primary outcomes
1
Description
Sore throat
Timepoint
24 hours
Method of measurement
4-point scale table
Secondary outcomes
1
Description
severity of pain
Timepoint
24 hours
Method of measurement
Visual Analogue scale
Intervention groups
1
Description
Group A: 8 mg intravenous Dexametasone 30 minutes before intubation
Category
Treatment - Drugs
2
Description
Group B: 8 mg intravenous Dexametasone 30 minutes after intubation
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Mahmood Eidy
Street address
Operating room, Emam Reza Hospital
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Meshkini
Street address
Faculty of Medicine
City
Tabriz
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
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
Tabriz University of Medical Sciences
Full name of responsible person
Parisa Sadeghian
Position
Medical Student
Other areas of specialty/work
Street address
Operation room, Emam Reza hospital
City
Tabriz
Postal code
516568
Phone
+98 41 1334 7054
Fax
+98 41 1335 2076
Email
pink.blossom@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahmood Eidy
Position
Anesthesiologist, Associate professor
Other areas of specialty/work
Street address
Emam Reza Hospital
City
Tabriz
Postal code
516568
Phone
+98 41 1334 7054
Fax
+98 41 1335 2076
Email
eidym@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Seyed Javad Seyed Toutounchi
Position
Otolaryngologist, Associate professor
Other areas of specialty/work
Street address
ENT department, Emam Reza Hospital
City
Tabriz
Postal code
5165683743
Phone
+98 41 1334 9435
Fax
+98 41 1335 2076
Email
totonchis@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)