Sore throat and cough are common complications after general anesthesia. This study has been designed to determine the effect of lidocaine gargle on the sore throat and cough after surgery caused by endotracheal intubation. 54 patients were enrolled in this study. They had between 18 and 80 years old and they candidate for elective ear surgery under general anesthesia with tracheal intubation in Amir Alam Hospital in the spring and summer of 2009. Exclusion criteriaes were difficult intubation, more than twice trying to intubation, operating time less than 60 minute and more than 180 minute and history of taking any medication and abuse of drugs. The patients randomly divided into two groups. First group gargled 1.5 mg/ kg Lidocaine in 30cc normal saline and 30 cc normal saline was gargled by second group five minutes before induction of anesthesia for 30 seconds. Two groups had similar method of anesthesia induction, maintenance and extubation. All information’s by questionnaire , gather by a trained person was achieved in the recovery room after full consciousness and 2 hours, 4 hours and 12 hours after surgery. The questionnaires have been considered 0 to 3 score for sore throat and cough severity.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201201028589N1
Registration date:2012-02-22, 1390/12/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-02-22, 1390/12/03
Registrant information
Name
Fatemeh Hajimohamadi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8802 2392
Email address
hajimoha@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2010-03-21, 1389/01/01
Expected recruitment end date
2010-09-23, 1389/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of lidocaine gargle on sore throat and cough caused by endotracheal intubation in Amir Alam Hospital
Public title
Effect of gargle on sore throat and cough caused by general anesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients candidate for elective ear surgery under general anesthesia with orotracheal intubation ; ASA physical status class I or II;age between 18 and 80 years old.
Exclusion criteria: Patients with operation time less than 60 minute and more than 180 minutes; anticipated difficult intubation; more than twice trying to intubation; NG tube need; upper respiratory tract infection; liver disease; opioid addiction; recent use of pain killers.
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
keshavarz bulvard,ghods street
City
tehran
Postal code
Approval date
2010-04-21, 1389/02/01
Ethics committee reference number
89-01-48-10535
Health conditions studied
1
Description of health condition studied
sore throat
ICD-10 code
j02
ICD-10 code description
Acute pharyngitis
Primary outcomes
1
Description
Sore throat
Timepoint
in PACU and 2, 4 and 12 hours after surgery
Method of measurement
Assessment carried out by trained nurses using the questionnaire.0 :No pain .1:mild pain, 2 : moderate pain, 3: sever pain
Secondary outcomes
1
Description
cough
Timepoint
in PACU and 2, 4 and 12 hours after surgery
Method of measurement
questionnaire
Intervention groups
1
Description
Intervention group gargled 1.5 mg/ kg Lidocaine in 30cc normal saline five minutes before induction of anesthesia for 30 seconds
Category
Prevention
2
Description
30 cc normal saline was gargled by second group five minutes before induction of anesthesia for 30 seconds
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Alam Hospital
Full name of responsible person
Street address
north sadi
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research
Full name of responsible person
Mrs Norozzade
Street address
Ghods Street, keshavarz Bulvard
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research
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
Tehran University of Medical Science
Full name of responsible person
Fatemeh Hajimohamadi
Position
anesthesiologist
Other areas of specialty/work
Street address
,Amir Alam Hospital, North Sadi
City
Tehran
Postal code
Phone
+98 21 8880 6976
Fax
Email
hajimoha@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Fatemeh Hajimohamadi
Position
anesthesiologist
Other areas of specialty/work
Street address
Amir Alam Hospital, North Sadi,
City
tehran
Postal code
Phone
+98 21 8880 6976
Fax
Email
hajimoha@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)