Protocol summary

Summary
1- Objectives: The aim of this study was to find the best way laryngeal mask insertion, in people with a body mass index over 30, which could lead to less complications in patients. 2- Design: In this study insertion of laryngeal mask in patients undergoing general anesthesia are, to classical methods, will be compared with lateral and rotational. The best method with the least side effects is indicated in patients with a body mass index above 30 is used. 3- Setting and conduct: After ethical approval by the Tabriz University of Medical Sciences faculty of medicine , 135 patients with the BMI more than 30 candidates for orthopedic surgeries with anesthesia will be studied in this prospective clinical trial, and randomly divided into three groups using the software will be made. Induction of the anesthesia will be similar in all patients including : pre-oxygenation by 100% oxygen , Midazolam 0.03 mg/kg , Fentanyl 1-2 µg/kg , Propofol 2-3 mg/kg .An anesthesiologist which is expert in inserting LMA in 20-30 seconds will insert the LMA with three techniques standards , lateral and rotational . the patients will be monitored by NIBP, HR, ECG, Pulse Oximetery and ETCO₂. 4- Participants outcome including major eligibility criteria; Inclusion criteria: The obese patients with BMI more than 30 ; Candidate for anesthesia with laryngeal mask insertion. Exclusion criteria: Body mass index less than 30; During the operation more than 2 hours; Other than the supine position surgery; In head and neck surgery; Patients at risk for aspiration; Patients known to have airway problems; Multiple attempts to put the laryngeal mask. 5- Intervention: laryngeal mask to classical methods, Insertion of laryngeal mask to classical methods, lateral and rotational in patients with a body mass index over 30 by the anesthesiologist. 6- Main (measures) variables: The data to be recorded will be: LMA insertion time, number of insertion tries, leak around LMA and grading it by ventilation with the pressure of 20 cmH₂O as: Grade one: no leak; Grade two: feeling of leak; Grade three: feeling of leak with sound with appropriate ventilation; Grade four: feeling of leak with sound with inappropriate ventilation; Grade five: complete airway obstruction. Assessment of appropriate ventilation using: ETCO₂ , good chest movements and continuous oxygenation. complications like blood on the mask of LMA , sore throat as none , mild , moderate and severe and any change in patient voice will be recorded.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201510107313N4
Registration date: 2015-12-02, 1394/09/11
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-12-02, 1394/09/11
Registrant information
Name
Mirmohammadtaghi Mortazavi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3669 1953
Email address
mortazavimt@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
The costs of patient surgery and additional costs for projects not required. Through Medical insurance will be provided.
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of success rate of classic Laryngeal mask insertion on the first try with three different technique: the classic methods, lateral and rotational in obese patients with BMI more than 30
Public title
Evaluation of success rate of classic Laryngeal mask insertion
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: the obese patients with BMI more than 30 ; Candidate for anesthesia with laryngeal mask insertion Exclusion criteria: Body mass index less than 30; During the operation more than 2 hours; Other than the supine position surgery; In head and neck surgery; Patients at risk for aspiration; Patients known to have airway problems; Multiple attempts to put the laryngeal mask.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 135
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not 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 Tabriz University of Medical Sciences
Street address
Ethics Committee of Tabriz University of Medical Sciences, Golgasht Ave, Tabriz, I.R.Iran
City
Tabriz
Postal code
51665118
Approval date
2015-05-28, 1394/03/07
Ethics committee reference number
5/4/2398

Health conditions studied

1

Description of health condition studied
Obesity
ICD-10 code
E66.8,
ICD-10 code description
Other obesity,

Primary outcomes

1

Description
Success rate of the placement of the Laryngeal Mask
Timepoint
Immediately after the action
Method of measurement
The time required for proper placement of the Laryngeal Mask, The number of attempts for the Placement, Existence leakage around the laryngeal mask

Secondary outcomes

empty

Intervention groups

1

Description
insert the LMA with standard technique
Category
Other

2

Description
insert the LMA with rotational technique
Category
Other

3

Description
]nsert the LMA with lateral technique
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohada Hospital
Full name of responsible person
Mirmohammadtaghi Mortazavi
Street address
Shohada Hospital,Ghoshahr Avenue, Elgoli, Tabriz, IRAN
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-Chancellor for Research, Tabriz University of Medical Sciences
Full name of responsible person
Mortazavi Dr
Street address
Vice-Chancellor for Research, Tabriz University of Medical Sciences, Daneshgah Avenue, Tabriz, Iran
City
Tabriz
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, 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
Mirmohammadtaghi Mortazavi
Position
Scientific Board
Other areas of specialty/work
Street address
Operating room, Shohada Hospital, Gholgasht Avenue, Elgholi, Tabriz, Iran
City
Tabriz
Postal code
Phone
+98 41 3669 1953
Fax
Email
mortazavimmt@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Department of Anesthesiology, Tabriz University Of Medical Sciences
Full name of responsible person
Masud Parish
Position
Scientific Board
Other areas of specialty/work
Street address
Department Of Anesthesiology,Medical School, Tabriz University Of Medical Sciences, Daneshghah Avenue, Tabriz, Iran
City
Tabriz
Postal code
Phone
+98 41 3334 1994
Fax
Email
masoudparish@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mirmohammadtaghi Mortazavi
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Shohada Hospital, Gholshahr Avenue, Elgholi, Tabriz, Iran
City
Tabriz
Postal code
Phone
+98 41 3334 1994
Fax
Email
mortazavimmt@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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