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Appropriate Time for Laryngeal Mask Airway Insertion in Patients Undergoing General Anesthesia

Protocol summary

Summary
In this prospective clinical trial 96 patients undergoing orthopedic surgeries will be studied in four groups . The aim of the study is to determine appropriate time for laryngeal mask airway insertion in patients undergoing general anesthesia .Inclusion Criteria : procedures less than 60 minutes ; patients between 16-65 year age ; American Society of Anesthesiologists class 1 & 2 . Exclusion Criteria : Difficult Airway ; Trauma in face and neck ; aspiration probability .According to the time of laryngeal mask insertion the patients will be included in four groups : group one 0-15 seconds , group two 16-30 seconds , group three 31-45 seconds and group four 46-60 seconds after completion of propofol injection. Induction of the anesthesia will be similar in all patients including propofol 2mg/kg , fentanyl 2 µg/kg and midazolam 0.03 mg/kg . Propofol will be injected during 30 seconds . Injection of the drugs and insertion of the LMA will be done by two anesthesiologists . Data will be recorded in a questionary form including : age , sex , ease of insertion , need for more drugs , blood pressure before the drugs and 1,3,5 minutes after LMA insertion , heart rate before the drugs and 1,3,5 minutes after LMA insertion , insertion time , gag reflex , cough , movements , laryngospasm , SaO2 before and after insertion , possibility of ventilation , sore throat after surgery , number of tries to insert LMA , mouth opening , and leak around the LMA cuff .

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016020226328N1
Registration date: 2016-04-25, 1395/02/06
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-04-25, 1395/02/06
Registrant information
Name
Masoud Parish
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3385 5842
Email address
parishm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-07-20, 1395/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Appropriate Time for Laryngeal Mask Airway Insertion in Patients Undergoing General Anesthesia
Public title
Time for Laryngeal Mask Airway Insertion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : procedures less than 60 minutes ; patients between 16-65 year age ; American Society of Anesthesiologists class 1 & 2 Exclusion criteria : Difficult Airway ; Trauma in face and neck ; aspiration probability
Age
From 16 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 96
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
Tabriz University of Medical Sciences
Street address
shohada Hospital ; Gholshahr Street ; Tabriz ; Iran
City
Tabriz
Postal code
Approval date
2015-12-07, 1394/09/16
Ethics committee reference number
TBZMED.REC.1394.830

Health conditions studied

1

Description of health condition studied
GENERAL ANESTHESIA
ICD-10 code
T88.4
ICD-10 code description
FAILED or DIFFICULT INTUBATION

Primary outcomes

1

Description
Appropriate Insertion Time
Timepoint
after intervention
Method of measurement
time

Secondary outcomes

1

Description
Hemodynamic Changes
Timepoint
after intervention
Method of measurement
monitoring

Intervention groups

1

Description
Four groups will be studied in regard of quality of laryngeal mask insertion . Quality of laryngeal mask insertion at different time interval after propofol injection will be studied . Laryngeal mask airway is a supraglottic airway device which is used to protect airway .Group one :Anesthesia will be induced with midazolam 0.03 mg/kg, fentany 2microgram/kg and propofol 2 mg/kg and while ventilating the patient , between 0 - 15 seconds after propofol injection the laryngeal mask will be inserted in a manner that tip of the index finger is at the back of the mask and the device is gently pushed down after the mouth is opened and when feeling a resistance the procedure is completed and the mask is fixed and the data about the quality of laryngeal mask insertion will be recorded .
Category
Other

2

Description
Group two : Anesthesia will be induced with midazolam 0.03 mg/kg, fentany 2microgram/kg and propofol 2 mg/kg and while ventilating the patient , between16 - 30 seconds after propofol injection the laryngeal mask will be inserted in a manner that tip of the index finger is at the back of the mask and the device is gently pushed down after the mouth is opened and when feeling a resistance the procedure is completed and the mask is fixed and the data about the quality of laryngeal mask insertion will be recorded .
Category
Treatment - Drugs

3

Description
Group three :Anesthesia will be induced with midazolam 0.03 mg/kg, fentany 2microgram/kg and propofol 2 mg/kg and while ventilating the patient , between 31 - 45 seconds after propofol injection the laryngeal mask will be inserted in a manner that tip of the index finger is at the back of the mask and the device is gently pushed down after the mouth is opened and when feeling a resistance the procedure is completed and the mask is fixed and the data about the quality of laryngeal mask insertion will be recorded .
Category
Treatment - Drugs

4

Description
Group four : Anesthesia will be induced with midazolam 0.03 mg/kg, fentany 2microgram/kg and propofol 2 mg/kg and while ventilating the patient , between46 - 60 seconds after propofol injection the laryngeal mask will be inserted in a manner that tip of the index finger is at the back of the mask and the device is gently pushed down after the mouth is opened and when feeling a resistance the procedure is completed and the mask is fixed and the data about the quality of laryngeal mask insertion will be recorded.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Tabriz University of Medical Sciences
Full name of responsible person
Parish Masoud
Street address
Shohada Hospital , Gholshahr Street , Tabriz , Iran
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
parish Masoud
Street address
Shohada Hospital
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Parish Masoud
Position
Anesthesiologist/Associate Professor
Other areas of specialty/work
Street address
Shohada Hospital ; Gholshahr Street ; Tabriz ; Iran
City
Tabriz
Postal code
Phone
+98 41 3385 5842
Fax
Email
parishm@tbzmed.ac.irmasoudparish@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
Parish Masoud
Position
Anesthesiologist/Associate Professor
Other areas of specialty/work
Street address
Shohada Hospital ; Gholshahr Street ; Tabriz ; Iran
City
Tabriz
Postal code
Phone
+98 41 3385 5842
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
Parish Masoud
Position
Anesthesiologist/Associate Professor
Other areas of specialty/work
Street address
Shohada Hospital ; Gholshahr Street ; Tabriz ; Iran
City
Tabriz
Postal code
Phone
+98 41 3385 5842
Fax
Email
parishm@tbzmed.ac.irmasoudparish@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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