Comparison of efficacy, ease and speed of insertion and post operative complications of classic laryngeal mask airway (C-LMA) using four different methods in elective surgeries under general anesthesia
Objectives: Comparison of efficacy, ease and speed of insertion and post operative complication of classic laryngeal mask airway (C-LMA) in four different methods in elective surgeries under general anesthesia.
Design: Single blind randomized clinical trial
Setting and conduct: All the participants will undergo 4 different methods of laryngeal mask insertion and the efficacy as well as complications would be compared between groups.
Participants including major eligibility criteria: 200 patients scheduled for cataract surgery. Inclusion criteria: BMI 20-30; ASA I,II. Exclusion criteria: Sore throat, COPD, the patient with high risk for stomach content aspiration
Intervention: Laryngeal mask insertion through 4 different methods.
Main outcome measures: Efficacy, complication
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202159025N1
Registration date:2012-04-12, 1391/01/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-04-12, 1391/01/24
Registrant information
Name
Masood Zangi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4670
Email address
mzangi@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Expected recruitment start date
2012-02-29, 1390/12/10
Expected recruitment end date
2012-05-02, 1391/02/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy, ease and speed of insertion and post operative complications of classic laryngeal mask airway (C-LMA) using four different methods in elective surgeries under general anesthesia
Public title
Comparison of four ways for insertion of laryngeal mask
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: Body Mass Index (BMI) ranging from 20 to 30; ASA I,II
Exclusion Criteria: Upper respiratory tract infection; sore throat; COPD; patients with high risk of aspiration (e.g Diabetes, gasteroesophagial reflux, diaphragmatic hernia, operation for more than 2 hours, position except supine and lithotomy)
Age
From 18 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
200
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
Ethics Committee of Shiraz University of Medical Sciences
Street address
Ethics Committee, 7th Floor, Shiraz University of Medical Sciences central building, Zand Avenue
City
Shiraz
Postal code
71345-1978
Approval date
2012-02-12, 1390/11/23
Ethics committee reference number
CT-90-1898
Health conditions studied
1
Description of health condition studied
Cataract
ICD-10 code
H25.0
ICD-10 code description
Senile incipient cataract
Primary outcomes
1
Description
Laryngeal mask insertion time
Timepoint
During mask insertion, 1 and 6 hours later
Method of measurement
Chronometer
2
Description
Successful laryngeal mask insertion
Timepoint
During mask insertion
Method of measurement
Incidence (Percentage)
3
Description
Complication of laryngeal mask insertion
Timepoint
During mask insertion, 1 and 6 hours later
Method of measurement
Incidence (Percentage)
Secondary outcomes
1
Description
Incidence of hoarseness
Timepoint
1 and 6 hours after operation
Method of measurement
Incidence (Percentage)
2
Description
Incidence of sore throat
Timepoint
1 and 6 hours after operation
Method of measurement
Incidence (Percentage)
3
Description
Incidence of neck pain
Timepoint
1 and 6 hours after operation
Method of measurement
Incidence (Percentage)
Intervention groups
1
Description
1st Method: Standard method: The patient’s head is extended by one hand and the proximal part of LMA is placed in the other hand in such a way that it is entered the patient mouth from gap surface side. Then, the LMA is moved along the hard palate with the forefinger until a resistance is felt due to oropharynx and the cuff is expanded based on manometer and finally the leakage is checked.
Category
Treatment - Surgery
2
Description
2nd Method: Lateral method: The patient’s head is extended by one hand and the proximal part of LMA is placed in the other hand in such a way that it is entered the patient mouth as standard method in such a way that the entire cuff is located in mouth. Then, the cuff is rotated at 45 degree angle laterally in such a way that only tongue side is in contact with mask edge. Then, the forefinger and thumb is used to move it along the mouth until a resistance is felt. Finally, the mask is rotated 45 degree in opposite direction and located in middle position and the cuff is expanded based on manometer and leakage is checked.
Category
Treatment - Surgery
3
Description
3rd Method: Rotational method: The patient’s head is extended by one hand and the proximal part of LMA is placed in the other hand in such a way that it is entered the patient mouth with 180 degree angle (the mask gap is toward hard palate). Then, it is moved along the mouth until a resistance is felt. Finally, it is rotated 180 degree and fixed behind the larynx and the cuff is expanded based on manometer and leakage is checked, and the cuff is expanded based on manometer and leakage is checked.
Category
Treatment - Surgery
4
Description
4th Method: Modified standard method: This method is similar to the standard method except for the mask is moved in its paths without using any fingers.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz University of Medical Sciences
Full name of responsible person
Gholamreza Hatam
Street address
Vice chancellor for research, 7th floor, Shiraz University of Medical Sciences central building, Zand Avenue
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Medical Sciences
Full name of responsible person
Gholamreza Hatam
Street address
Vice chancellor for research, 7th floor, Shiraz University of Medical Sciences central building, Zand Avenue
City
Shiraz
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, Shiraz University of Medical Sciences