comparison of the side effects of extubation during the use of intravenous lidocaine in higher and lower 50 years old people who candidate of internal laparoscopic cholecystectomy surgery.
Determining the effect of age on the side effects of octobasone when using intravenous lidocaine in people undergoing internal laparoscopic cholecystectomy surgery.
Design
The number of 122 patients with the mentioned entry criteria in two age groups under 50 years and over 50 years will be divided into two age groups of 61 people.
Settings and conduct
In the mentioned procedures, after the end of the surgical procedure and the need for extubation, 90 seconds before extubation, intravenous lidocaine with a dose of 1 mg/kg is injected to the patient, and then the criteria for laryngospasm and bronchospasm in the interval: immediately after extubation Until the time of exit from the recovery, also three parameters of sore throat, cough and aspiration will be evaluated and charted from the beginning of extubation until the time of exit from the recovery.
Participants/Inclusion and exclusion criteria
The criteria for entering this study is to be at least 18 years old and not pregnant, not having any conditions such as: heart disease, kidney and liver failure, history of cardiopulmonary resuscitation, history of respiratory disease, high blood pressure, mental retardation or psychological disease, and sensitivity to lidocaine.
Intervention groups
In this study, the intervention group includes people over 50 years old who will receive lidocaine. The control group is people who have received lidocaine but are under 50 years old.
Main outcome variables
Incidence of extubation complications
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230227057548N1
Registration date:2023-05-15, 1402/02/25
Registration timing:registered_while_recruiting
Last update:2023-05-15, 1402/02/25
Update count:0
Registration date
2023-05-15, 1402/02/25
Registrant information
Name
Mohammad Mohammadifard
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 84 3337 5525
Email address
mmohammadifard2001@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-16, 1401/12/25
Expected recruitment end date
2024-03-15, 1402/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of the side effects of extubation during the use of intravenous lidocaine in higher and lower 50 years old people who candidate of internal laparoscopic cholecystectomy surgery.
Public title
comparison of the age effect on the side effects of extubation during the use of lidocaine
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Being at least 18 years old
candidate of internal laparoscopic cholecystectomy surgery
consent to participate in the study
Exclusion criteria:
pregnancy
heart disease
liver failure
history of cardiopulmonary resuscitation
history of respiratory disease
high blood pressure
mental retardation
sensitivity to lidocaine
psychological illness
Kidney failure
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
122
More than 1 sample in each individual
Number of samples in each individual:
1
In each group, intravenous lidocaine was given 90 seconds before extubation, and then the positive effects of lidocaine in improving the complications of extubation were measured.
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, consent is obtained from the participants, but no explanation is given regarding the age range that is the subject of the study, and also the information that reaches the data analyst is coded and blinded. Each of them does not know the information about which age range they are.
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Ilam University of Medical Sciences
Street address
saleek street
City
ilam
Province
Ilam
Postal code
6931473414
Approval date
2023-02-28, 1401/12/09
Ethics committee reference number
IR.MEDILAM.REC.1401.268
Health conditions studied
1
Description of health condition studied
In people undergoing internal laparoscopic cholecystectomy surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
In this study, the primary outcome is the incidence of laryngospasm, which is determined and charted by the capnograph tool.
Timepoint
Immediately after extubation until exit from recovery for each patient in the study
Method of measurement
Side stream capnograph is used to measure laryngospasm.
2
Description
The incidence of bronchospasm is determined and charted by the capnograph tool.
Timepoint
Immediately after extubation until exit from recovery for each patient in the study
Method of measurement
side stream capnograph is used to measure bronchospasm.
3
Description
The amount of sore throat that will be used through the Visual Analogue Scale.
Timepoint
Immediately after extubation until exit from recovery for each patient in the study
Method of measurement
The Visual Analogue Scale for measuring pain represents a 10 cm line printed on a piece of paper with markers at each end indicating "no pain" at one end and "worst pain" at the other end or It is "indescribable pain".
4
Description
The number of coughs counted and charted by the researcher.
Timepoint
Immediately after extubation until exit from recovery for each patient in the study
Method of measurement
The number of coughs is counted by the researcher and recorded and charted in three ranges: low, medium, and high.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: people undergoing internal laparoscopic cholecystectomy surgery, in this study, after obtaining informed consent from the patient's companion and after the completion of the surgery and the need for extubation 90 seconds before extubation, intravenous lidocaine at a dose of 1 mg/kg was injected into the patient. And after that, the parameters of laryngospasm and bronchospasm in the period after extubation until the time of leaving recovery, as well as the two criteria of sore throat and cough, from after extubation to the time of leaving recovery, will be evaluated and charted. In this study, 2% lidocaine ampoule of Caspian Tamim pharmaceutical company will be used.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital, Ilam
Full name of responsible person
mohammad mohammadifard
Street address
salek street
City
ilam
Province
Ilam
Postal code
6931473414
Phone
+98 901 983 2380
Email
mmohammadifard2001@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
abass maleki
Street address
salek street
City
ilam
Province
Ilam
Postal code
6931473414
Phone
+98 84 3337 5525
Email
mmohammadifard2001@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ilam 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
Ilam University of Medical Sciences
Full name of responsible person
mohammad mohammadifard
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Anesthesiology
Street address
salet street
City
ilam
Province
Ilam
Postal code
6931473414
Phone
+98 84 3337 5525
Email
mmohammadifard2001@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
aminolah vasig
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
salek street
City
ilam
Province
Ilam
Postal code
6931473414
Phone
+98 84 3337 5525
Email
aminvasigh1344@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Mohammad Mohammadifard
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Anesthesiology
Street address
Salek street
City
Ilam
Province
Ilam
Postal code
6931473414
Phone
+98 84 3337 5525
Fax
+98 84 3223 6914
Email
mmohammadifard2001@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
For each patient, information such as age, gender, underlying disease, treatment services, and the patient's clinical condition are recorded before surgery, and after that, laryngospasm, bronchospasm, sore throat, cough are recorded and shared.
When the data will become available and for how long
The start of the access period is 5 months after the results are published.
To whom data/document is available
People working in medical universities of the country
Under which criteria data/document could be used
In case of research on the vital condition of patients, including heart rate, breathing rate, blood pressure before and after surgery, access will be allowed.
From where data/document is obtainable
Those who want access can send a letter to my e-mail at mmohammadifard2001@gmail.com.
What processes are involved for a request to access data/document
It is required to be a member of the University of Medical Sciences with a valid certificate and also a certificate proving the completion of a research project related to the subject, as well as the amount of information required and the reason for using this information.