Laryngeal Mask Airway is used as an alternative device for endotracheal tube for intubation of the airway during anesthesia and surgery. Common complications after operation include sore throat, coughing and dysphagia which are common after using endotracheal tubes. Simultaneous use of LMA and low flow anesthesia seems logical to reduce these complications, cost and operative room pollution. Therefore we aimed to compare postoperative complications between LMA and Endotracheal tube during low flow anesthesia with controlled ventilation.
Eighty adult patients aging 20-60 years with ASA class I, II without the risk of airway problems, history of recent sore throat or cold and allergy to latex candidated for elective surgery will be included in this study. Patients will be randomly divided into two groups, in one group Laryngeal mask airway and in the other group endotracheal tube will be inserted.
Anesthetic induction will be performed in all patients and monitoring will include ECG, pulse oximetry, NIBP, inspiratory and expiratory concentrations of isoflurane and peak and plateau airway pressures. After removing the airway device, the patient will be transferred to the PACU and severity of sore throat, cough and dysphagia will be assessed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201203042582N5
Registration date:2012-03-15, 1390/12/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-03-15, 1390/12/25
Registrant information
Name
Ata Mahmoodpoor
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 914 116 0888
Email address
mahmoodpoora@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2012-01-30, 1390/11/10
Expected recruitment end date
2012-06-30, 1391/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of postoperation complication between Laryngeal Mask Airway and Endotracheal tube during low flow anesthesia with controlled ventilation
Public title
Comparison of postoperation complication between Laryngeal Mask Airway and Endotracheal tube during low flow anesthesia with controlled ventilation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: adult patients with ASA class I and II aging 20-60 years who are candidates for elective surgery
Exclusion criteria: possibility of air way problems, history of recent sore throat or a cold in the past 10 days, patients with latex allergy, patients with full stomach
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:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz university of medical sciences
Street address
golgasht street
City
tabriz
Postal code
Approval date
2011-02-28, 1389/12/09
Ethics committee reference number
4996/4/5
Health conditions studied
1
Description of health condition studied
dysphagia
ICD-10 code
R13
ICD-10 code description
dysphagia
Primary outcomes
1
Description
sore throat
Timepoint
every 6 hours until 24 hours
Method of measurement
asking from patient
2
Description
cough
Timepoint
every 6 hours until 24 hours
Method of measurement
asking from patient
Secondary outcomes
1
Description
dysphagia
Timepoint
every 6 hours until 24 hours
Method of measurement
asking from patient
Intervention groups
1
Description
interventiobn group: insertion of LMA
Category
Treatment - Other
2
Description
control group: insertion of endotracheal tube
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
nikookary hospital
Full name of responsible person
Ata Mahmoodpoor
Street address
Abbasi street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
research chancellor, tabriz university of medical sciences
Full name of responsible person
Alireza Ostadrahimi
Street address
golgasht street
City
tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
research chancellor, tabriz 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
tabriz university of medical sciences
Full name of responsible person
Afsaneh Mohammadi
Position
medical student
Other areas of specialty/work
Street address
nikookary hospital- abbasi street
City
tabriz
Postal code
Phone
+98 41 1657 7340
Fax
Email
afsanehmohammadi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
Ata Mahmoodpoor
Position
Assistant professor
Other areas of specialty/work
Street address
nikookary hospital- abbasi street
City
Tabriz
Postal code
Phone
+98 41 1657 7340
Fax
Email
amahmoodpoor@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)