Protocol summary

Summary
The aim of this study was to compare trapezius squeezing test versus jaw thrust as clinical indicators for appropriate condition for insertion of laryngeal mask airway. This triple blind randomized clinical trial study was done on 138 patients aged 20 to 70 years old undergoing minor surgeries, randomly allocated in T (trapezius squeezing test=69) or J (jaw thrust=69) group in Emam Reza hospital of Birjand university of medical sciences. The LMA was inserted after the loss of motional response to trapezius squeezing or jaw thrust. Heart rate and blood pressure was measured after induction of anesthesia as a base line. The variability more than 20% in blood pressure or heart rate 1 min after LMA insertion to the base line or the occurrence of coughing, gagging, gross purposeful movements, breath-holding, laryngospasm, or an SpO2 < 90% during LMA insertion were considered as an unsuccessful attempt. The incidence of successful attempt, insertion time were compared between two groups. Key points: Jaw thrust; Laryngeal mask airway; Trapezius squeezing test

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017070421383N7
Registration date: 2017-09-26, 1396/07/04
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-09-26, 1396/07/04
Registrant information
Name
Amir Saber Tanha
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3243 2778
Email address
dr.saber@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Birjand University of Medical Sciences
Expected recruitment start date
2017-05-05, 1396/02/15
Expected recruitment end date
2017-08-06, 1396/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison between the effect of using of trapezius squeezing test with jaw thrust maneuver on the incidence of successful attempts for LMA insertion.
Public title
comparing the effect of trapezius squeezing test versus jaw thrust maneuver on the incidence of successful attempts for LMA insertion.
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: All the patients aged 18 to 70 years old with American Society of Anesthesia physical status classification (ASA) 1 to 2 who were scheduled for elective surgeries. Exclusion criteria: Emergent surgeries; The patients with history of hypertension, dysautonomia, difficult intubation, neuropathy or plegia: symptoms of difficult intubation; addicted patients; substance abuse.
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 138
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The motor response recorded by an independent researcher who was not in the operating room while the test was performed. Also, the patients and the statistical researcher were uninformed about the study groups. For randomization we wrote numbers from 1 to 138 on separate papers and put it in envelops. Envelops were put in a box. At entrance to the operating room each patient picked up one envelope randomly from the box and gave it to the investigator who was responsible for doing maneuver. Squeezing the trapezius muscle for odd numbers and jaw thrust for even numbers was performed.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Birjand University of Medical Sciences
Street address
Birjand University of Medical Sciences, Ghafari Street, Birjand, Iran.
City
Birjand
Postal code
Approval date
2017-04-24, 1396/02/04
Ethics committee reference number
ir.bums.rec.1396.24

Health conditions studied

1

Description of health condition studied
general anesthesia
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
successful attempt
Timepoint
After laryngeal mask insertion
Method of measurement
observation

2

Description
insertion time
Timepoint
immediately after no response to maneuovers
Method of measurement
hour

Secondary outcomes

empty

Intervention groups

1

Description
trapezius sqeezing test
Category
Other

2

Description
jaw thrust
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza hospital of Birjand University of Medical Sciences.
Full name of responsible person
Dr. Amir Saber Tanha
Street address
City
Birjand

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Birjand University of Medical Sciences
Full name of responsible person
Dr. tooba kazemi
Street address
Vice Chancellor for research, Birjand University of Medical Sciences, Ghafari Street, Birjand, Iran
City
Birjand
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, Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Dr. Amir Saber Tanha
Position
Assisstant Professor of Anesthesia
Other areas of specialty/work
Street address
Birjand University of Medical Sciences, Ghafari Street, Birjand.
City
Birjand
Postal code
Phone
+98 56 3243 2778
Fax
Email
amirsaber63@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr. Amir Saber Tanha
Position
Assistant professor of anesthesia
Other areas of specialty/work
Street address
Birjand University of Medical Sciences, Ghafari Street, Birjand
City
Birjand
Postal code
Phone
+98 56 3243 2778
Fax
Email
amirsaber63@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr. Amir Saber Tanha
Position
Assistant professor of anesthesia
Other areas of specialty/work
Street address
Birjand University of Medical Sciences, Ghafari Street, Birjand
City
Birjand
Postal code
Phone
+98 56 3243 2778
Fax
Email
amirsaber63@gmail.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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