Sore throat is one of the most common complications of general anesthesia. The source of pain may be from pharyngeal, laryngeal or tracheal and may be the cause of unpleasantness, discomfort and a bad memory after general anesthesia. This study considers evaluating the effectiveness of lidocaine gel on the sore throat, cough and scratchy throat after insertion of a laryngeal mask airway.
Sixty patients who scheduled for elective eye surgery under general anesthesia and with criteria for inclusion in the study were randomly divided into two groups of intervention and control in one blind study. The posterior surface of LMAs was lubricated with lidocaine gel 2% in the intervention group and non-medical lubricant gel in the control group was used. After induction of anesthesia that was similar in all patients, the LMA was inserted using classical method by an anesthesiologist who was unaware of the gel that was used, and after ensuring adequate ventilation was fixed in place. Twenty-four hours after the operation the patient's sore throat, coughing and itchy throat were checked
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201304271766N5
Registration date:2013-05-08, 1392/02/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-05-08, 1392/02/18
Registrant information
Name
Karim Nasseri
Name of organization / entity
Kurdistan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 87 1666 3728
Email address
nasseri_k@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Kurdistan University of Medical sciences
Expected recruitment start date
2012-02-27, 1390/12/08
Expected recruitment end date
2013-06-27, 1392/04/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of topical lidocaine efficacy on respiratory complications after laryngeal mask airway insertion
Public title
Evaluation of Lidocaine efficacy on sore throat, cough and itching of the throat after laryngeal mask airway insertion
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: being candidate for elective eye surgery under general anesthesia; American society of Anesthesiologist physical status 1 or 2 and airway mallampati score 1 or 2.
Exclusion criteria: history of allergy to study drugs; history of recent upper respiratory tract infection and history of sore throat.
Age
From 15 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Kurdistan University of Medical Sciences Ethics Committee
Street address
Pasdaran Ave
City
Sanandaj
Postal code
Kurdistan
Approval date
2011-11-30, 1390/09/09
Ethics committee reference number
References number 10 of Second session of ethics committee- 25985/14
Health conditions studied
1
Description of health condition studied
Respiratory complications of general anesthesia
ICD-10 code
T88.5
ICD-10 code description
Other complications of anaesthesia
Primary outcomes
1
Description
Sore throut
Timepoint
24 hour after operation
Method of measurement
Physical examination
Secondary outcomes
1
Description
Cough
Timepoint
In post anesthesia care unit and 24 hour after operation
Method of measurement
Physical examination
2
Description
Itching of the throat
Timepoint
In post anesthesia care unit and 24 hour after operation
Method of measurement
Physical examination
Intervention groups
1
Description
Intervention group: The posterior surface of laryngeal mask airway will be lubricate with 2 ml 2% lidocaine gel
Category
Treatment - Drugs
2
Description
Control group : The posterior surface of laryngeal mask airway will be lubricate with 2 ml non-medical lubricant gel
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Beasat Hospital
Full name of responsible person
Karim Nasseri
Street address
Keshavarz Ave
City
Sanandaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kurdistan University of Medical Sciences
Full name of responsible person
Ataollah Heidari
Street address
Vice chancellor for research, Kurdistan University of Medical Sciences, Pasdaran Ave
City
Sanandaj
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, Kurdistan 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
Kurdistan University of medical Sciences
Full name of responsible person
Karim Nasseri
Position
Anesthesiologist / Associate Professor
Other areas of specialty/work
Street address
Departement of Anesthesia, Besat Hospital, Keshavarz Ave,
City
Sanandaj
Postal code
Phone
+98 87 1328 2002
Fax
+98 87 1328 2003
Email
nasseri_k@muk.ac.ir
Web page address
www.muk.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
karim Nasseri
Position
Anesthesiologist/Associate Professor
Other areas of specialty/work
Street address
Department of Anesthesia, Besat Hospital, Keshavarz Ave
City
Sanandaj
Postal code
Phone
+98 87 1328 2002
Fax
+98 87 1328 2003
Email
nasseri_k@muk.ac.ir
Web page address
www.muk.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
karim Nasseri
Position
Anesthesiologist/Associate Professor
Other areas of specialty/work
Street address
Department of Anesthesia, Beasat Hospital, Keshavarz Ave
City
Sanandaj
Postal code
Phone
+98 87 1328 2002
Fax
+98 87 1328 2003
Email
nasseri_k@muk.ac.ir
Web page address
www.muk.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)