Sore throat and cough are common complications after general anesthesia. This study has been designed to determine the effect of lidocaine gargle and dexamethasone gargle on the sore throat and cough after surgery caused by endotracheal intubation. 120 patients were randomly allocated into3 groups. First group gargle 10cc Lidocaine 1% and second group gargle 10cc normal saline with one dexamethasone ampule and third group gargle 10cc normal saline five minutes before induction of anesthesia for 10 seconds. . The patients were examined for sore throat (none, mild, moderate, or severe) each 6 h to 24 hours after extubation. Occurance of cough, laryngospasm were continously monitored and recorded during the observational period.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014122020336N2
Registration date:2015-03-04, 1393/12/13
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-03-04, 1393/12/13
Registrant information
Name
Ahmad Mirzaee
Name of organization / entity
Gonabad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 5722 3514
Email address
mirzaee.a@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Gonabad University of Medical Sciences
Expected recruitment start date
2015-04-05, 1394/01/16
Expected recruitment end date
2016-04-05, 1395/01/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of lidocaine and dexamethasone on gargle on pre-operative sore throat and coughing after extubation
Public title
Comparison of lidocaine and dexamethasone on gargle for sore throat and cough caused by general anesthesia.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: ASA physical status I to II; aged 18 to 80 years; surgical procedures under general anesthesia with orotracheal intubation in the supine position; not using corticosteroids and analgesics before operation.
exclusion criteria: patients undergoing oral cavity surgery; cervical spine surgery; thyroid surgery;patients with a difficult airway (after >2 orotracheal intubation attempt. requiring a nasogastric tube;or a history of perioperative sore throat. Patients with operation time less than 60 minute and more than 180 minutes
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Gonabad University of Medical Sciences.
Street address
The next of Asian road, Gonabad University of Medical Sciences
City
Gonabad
Postal code
Approval date
2014-03-12, 1392/12/21
Ethics committee reference number
GMU.REC.1392.51
Health conditions studied
1
Description of health condition studied
Sore throat
ICD-10 code
J02.9
ICD-10 code description
Acute pharyngitis
Primary outcomes
1
Description
Sore throat
Timepoint
In the recovery room after full consciousness, 6 h, 12 h and 18 h after surgery
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Cough
Timepoint
In the recovery room after full consciousness, 6 h, 12 h and 18 h after surgery
Method of measurement
Questionnaire
Intervention groups
1
Description
In the second group of 10 cc of distilled water for 10 seconds, gargle with dexamethasone in the sitting position
Category
Prevention
2
Description
The first group of patients in a sitting position for 10 seconds to 10 cc of 1% lidocaine gargle
Category
Prevention
3
Description
In the third group, 10 mL of saline gargle for 10 seconds in a sitting position
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospital of 15 Bidokht
Full name of responsible person
Ahmad Mirzaee
Street address
The next of Asian road, Gonabad University of Medical Sciences
City
Gonabad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Gonabad University of Medical Sciences
Full name of responsible person
Dr. Ali Mohammadpour
Street address
The next of Asian road, Gonabad University of Medical Sciences
City
Gonabad
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, Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Ahmad Mirzaee
Position
Student of Anesthesiology
Other areas of specialty/work
Street address
The next of Asian road, Gonabad University of Medical Sciences
City
Gonabad
Postal code
Phone
+98 51 5722 3028
Fax
Email
mirzaee.a@gmu.ac.ir; sarcheshme89@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr. Mohammad Taghi khodadadi
Position
Assistant Professor
Other areas of specialty/work
Street address
The next of Asian road, Gonabad University of Medical Sciences
City
Gonabad
Postal code
Phone
+98 915 533 5106
Fax
Email
dr_khodadadi_m@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Ahmad Mirzaee
Position
Student of Anesthesiology
Other areas of specialty/work
Street address
The next of Asian road, Gonabad University of Medical Sciences
City
Gonabad
Postal code
Phone
+98 51 5722 3028
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)