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Comparison of hemodynamic changes in the use of two methods of trapezius compression and mandibular lifting to determine the right time to insert a laryngeal mask in patients under general anesthesia with sodium thiopental

Protocol summary

Study aim
1. Comparison of average systolic and diastolic blood pressure of patients before and 2 minutes after induction and after LMA insertion 2. Comparison of the average heart rate of patients 2 minutes after induction and after LMA insertion in each of the two methods 3. Comparison of the average SpO2 of patients 2 minutes after induction and after LMA placement in two methods 4. Comparison of the average LMA insertion time in two methods 5. Comparison of hemodynamic changes compared to the base level
Design
A clinical trial with two intervention groups of 69 patients each, double-blind, simple randomization by block method and matching
Settings and conduct
The place of study is the operating room of Imam Reza Hospital, Birjand city After obtaining informed consent and recording information, the patients will be randomly divided into two groups A (squeezing the trapezius muscle) and B (pulling up the lower jaw) and induction of anesthesia with midazolam, fentanyl and sodium thiopental drugs as an anesthetic without blocking drugs. It is done neuromuscularly Then, one minute after the induction of anesthesia, one of the trapezius muscle squeezing maneuvers or the mandibular lifting maneuver is performed every 20 seconds until the
Participants/Inclusion and exclusion criteria
Inclusion criteria: 18-70 years old, having informed consent Exit criteria for emergency, suffering from uncontrolled systemic disease, hemodynamic instability, pregnancy, blood pressure, drug abuse, malampathy 2 or higher, body mass index greater than 30, neck movement disorder, difficulties in opening the mouth and the inability to ventilate after using a laryngeal mask.
Intervention groups
Group A - trapezius muscle squeezing maneuver Group B - lower jaw lifting maneuver(common method)
Main outcome variables
Systolic, diastolic and average blood pressure, heart rate, arterial blood oxygen saturation percentage

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221115056503N1
Registration date: 2023-02-01, 1401/11/12
Registration timing: retrospective

Last update: 2023-02-01, 1401/11/12
Update count: 0
Registration date
2023-02-01, 1401/11/12
Registrant information
Name
Hosein Abdollahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3220 4024
Email address
hoseinabdollahi@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-22, 1401/09/01
Expected recruitment end date
2022-12-21, 1401/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of hemodynamic changes in the use of two methods of trapezius compression and mandibular lifting to determine the right time to insert a laryngeal mask in patients under general anesthesia with sodium thiopental
Public title
Comparison of hemodynamic changes in the use of two methods of trapezius compression and mandibular lifting to determine the right time to insert a laryngeal mask in patients under general anesthesia with sodium thiopental
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 to 70 years Having informed consent to enter the study Patient in need of general anesthesia
Exclusion criteria:
Emergency Body mass index is greter than 30 Uncontrolled systemic disease Hemodynamic instability Uncontroled Hypertention Pregnancy Substance abuse mallampathy more than 2 Limitation of neck extension Difficulties inopening the mouth and impossibility of ventilation fter laryngeal msk application
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 138
Randomization (investigator's opinion)
Randomized
Randomization description
After determining the eligible people to enter the study for random assignment between two groups (group A: squeezing the trapezius muscle and group B: raising the lower jaw), a random block method with concealment will be used. There are four (AABB, BBAA, ABAB, BABA, ABBA, BAAB) and each block will be randomly selected. RANDBETWEEN command (random selection with repetition) was used in Excel software to generate a random sequence (selection of blocks). Closed opaque envelopes will be used for concealment.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients do not know how to be placed in groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Birjand University of Medical Sciences
Street address
No. 9, Allay No. 13, Adel St
City
Birjand
Province
South Khorasan
Postal code
9717677715
Approval date
2022-11-09, 1401/08/18
Ethics committee reference number
IR.BUMS.REC.1401.302

Health conditions studied

1

Description of health condition studied
Candidates for surgery under general anesthesia
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Hemodynamic changes and LMA operation time in patients under general anesthesia
Timepoint
Before induction, every twenty seconds after the first minute and two minutes after induction
Method of measurement
Patient monitoring in the operating room

Secondary outcomes

empty

Intervention groups

1

Description
1- Pulling the lower jaw up (common method): placing the fingers in the angle of the mandible on both sides and pulling the lower jaw upwards and checking the patient's movement response
Category
Treatment - Other

2

Description
Intervention group2: Squeezing the trapezius muscle on both sides at a distance of two to three centimeters from the root of the neck between the first and second fingers of the hand and examining the patient's motor response.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital, Birjand city
Full name of responsible person
Hosein Abdollahi
Street address
Taleghani Street, Imam Reza Hospital
City
Birjand
Province
South Khorasan
Postal code
9717677715
Phone
+98 56 3162 4000
Email
hoseinabdollahi@bums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mohammd hosein Nmaei
Street address
No 9 , allay No 13 , Adl st
City
Birjand
Province
South Khorasan
Postal code
9717677715
Phone
+98 56 3220 4024
Email
hoseinabdollahi@bums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Hosein Abdollahi
Position
Anesthesiology resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Adl st
City
Birjnd
Province
South Khorasan
Postal code
9717677715
Phone
+98 56 3220 4024
Email
ihoseinabdollah@bums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Hosein Abdollahi
Position
Anesthesiology resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Adl st
City
Birjnd
Province
South Khorasan
Postal code
9717677715
Phone
+98 56 3220 4024
Email
ihoseinabdollah@bums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Hosein Abdollahi
Position
Anesthesiology resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Adl st
City
Birjnd
Province
South Khorasan
Postal code
9717677715
Phone
+98 56 3220 4024
Email
ihoseinabdollah@bums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no need to share non-identifiable personal data of the participants, and there is no scientific justification for publishing this data
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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