The purpose of this study is to compare the incidence and severity of post-surgery sore throat after insertion of LMA in traditional and new method.
This is a clinical trial study. The study population will patients undergoing phaco surgery in Khatam-al-Anbia hospital.
Inclusion criteria: ASA I & II, phaco surgery, age over 16 year. Exclusion criteria are catching cold and sore throat.
80 patients will divided in two groups randomly.
Intervention in this study is type of insertion LMA.
All patients will be under general Anesthesia in a same way and will divide in group A & B randomly. In group A, LMA will insert by dominant hand with support of index finger under proximal of non-laryngeal mask cuff (conversional method). In group B laryngeal mask will insert with dominant hand and non-dominant hand on non-laryngeal cuff so avoid of LMA to contact and damage upper palate and oropharyngial tissue (new method).
After awaking patients in recovery and one day after surgery sore throat will evaluate. Time of this study will be in September of 2013.
Result of this study: Are new method of insertion of LMA cause to decrease of post-operative sore throat.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013081911200N2
Registration date:2013-09-01, 1392/06/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-09-01, 1392/06/10
Registrant information
Name
Mohsen Akhondi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1802 2711
Email address
akhondim901@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Science
Expected recruitment start date
2013-08-23, 1392/06/01
Expected recruitment end date
2013-09-23, 1392/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of sore throat after the operation after insertion of laryngeal mask airway in conventional method with new technique
Public title
Sore throat after new technique of insertion of LMA
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: ASA I & II, phaco surgery, age over 16 year.
Exclusion criteria are catching cold and sore throat.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Science
Street address
Fakori Blv.
City
Mashhad
Postal code
Approval date
2013-08-17, 1392/05/26
Ethics committee reference number
920257
Health conditions studied
1
Description of health condition studied
sore throat
ICD-10 code
R07.0
ICD-10 code description
Pain in throat
Primary outcomes
1
Description
Sore throat
Timepoint
After surgery and one day later
Method of measurement
Asking patient
Secondary outcomes
empty
Intervention groups
1
Description
In intervention group, laryngeal mask will insert with dominant hand and non-dominant hand on non-laryngeal cuff so avoid of LMA to contact and damage upper palate and oropharyngial tissue (new method)
Category
Treatment - Other
2
Description
In control groups, LMA will insert by dominant hand with support of index finger under proximal of non-laryngeal mask cuff (conversional method)
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam-al-Anbia Hospital
Full name of responsible person
Dr Mohammad Gharavi Fard
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Science
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Anesthesiology Department, Imam Reza Hospital
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Science
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
Mashhad University of Medical Science
Full name of responsible person
Dr Mohammad Gharavi fard
Position
Associate Professor
Other areas of specialty/work
Street address
Anesthesiology Department, Imam Reza Hospital
City
Masshad
Postal code
Phone
+98 51 1802 2711
Fax
Email
GharaviM@mums.ac
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Science
Full name of responsible person
Dr Mohammad Gharavi fard
Position
Associate Professor
Other areas of specialty/work
Street address
Anesthesiology Department, Imam Reza Hospital
City
Mashhad
Postal code
Phone
+98 51 1802 2711
Fax
Email
GharaviM@mums.ac
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Science
Full name of responsible person
Dr Mohsen Akhondi
Position
Resident
Other areas of specialty/work
Street address
Anesthesiology Department, Imam Reza Hospital
City
Mashhad
Postal code
Phone
+98 51 1802 2711
Fax
Email
akhondim901@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)