The Effect of Carina Anesthesia with Topical Lidocaine in Endotracheal Suction on Hemodynamic parameters and bucking in Adult Patient After Cardiac Surgery
Determining the effect of Karina anesthesia by topical administration of lidocaine on endotracheal suctioning on hemodynamic parameters and strain in adult patients after heart surgery
Design
Clinical trial with control group, double-blind, randomized, phase 2 and 3 on 64 patients. Random number table was used for randomization.
Settings and conduct
The place is Shahid Rajaei Heart Hospital. endotracheal suctioning is performed after the intervention. Changes in hemodynamic and bucking indices are checked 2 minutes before and during and 2 minutes after endotracheal suctioning. The patient and the recorder are kept blind.
Participants/Inclusion and exclusion criteria
entrance:
1. Being in the age range of 18 to 65 years
2. Patients undergoing heart surgery who have undergone one of the following surgeries: coronary, valve, or both.
3- Having a full level of consciousness (15/15) before admission for surgery.
4- Having stability in the hemodynamic range
No entry:
1- No airway abnormalities or unusual use of endotracheal tubes
2. No history of lidocaine allergy
Intervention groups
4 cc of 2% lidocaine in the target group and 4 cc of normal saline 0.9% in the control group is apply into the trachea and then the trachea is sucked.
Main outcome variables
Hemodynamic indicators; Cough reflex (bucking)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201011048991N1
Registration date:2020-12-19, 1399/09/29
Registration timing:registered_while_recruiting
Last update:2020-12-19, 1399/09/29
Update count:0
Registration date
2020-12-19, 1399/09/29
Registrant information
Name
Hoda Abedi
Name of organization / entity
Shahid Rajaei Cardiovascular Research and Therapeutic Training Center
Country
Iran (Islamic Republic of)
Phone
+98 21 2392 3312
Email address
abedi.hoda.ha@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-10, 1399/08/20
Expected recruitment end date
2020-12-20, 1399/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Carina Anesthesia with Topical Lidocaine in Endotracheal Suction on Hemodynamic parameters and bucking in Adult Patient After Cardiac Surgery
Public title
"The effect of local anesthesia of carina in suction on hemodynamic and physiological parameters"
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
consent to participate in the study
Having a full level of consciousness (15/15) before admission for surgery
Having stability in the patient's hemodynamic range
Patients who need suction due to accumulation of secretions
Exclusion criteria:
No history of lidocaine allergy
Absence of any airway abnormalities or the use of unusual airway endotracheal tubes
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, random allocation is done in block form. Groups are divided into 8 groups of 8. The target group is named with the letter A and the control group with the letter B. Randomization was performed individually with statistical software. In each block, 4 positions are assigned to A and 4 positions to B. Each of these letters was assigned to a project participant in the order recorded in the block table. Depending on whether it was A or B, lidocaine or normal saline was used during suctioning and the data were recorded.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the study participant (patient) and the data recorder were kept blind. The procedure is that one nurse is aware of which group the patient is in, and the second nurse writes down the data without knowing the patient group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Rajaei Cardiovascular Research and Training Center
Street address
Rajaei Heart Center,Valiasr St
City
Tehran
Province
Tehran
Postal code
19969 11151
Approval date
2020-11-07, 1399/08/17
Ethics committee reference number
IR.RHC.REC.1399.089
Health conditions studied
1
Description of health condition studied
tracheal suction
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Hemodynamic parameters
Timepoint
2 minutes before and during and 2 minutes after tracheal suction
Method of measurement
Cardiopulmonary monitoring devices
2
Description
bucking in Intubated patient
Timepoint
2 minutes before and during and 2 minutes after tracheal suction
Method of measurement
Mild (less than 3 times), moderate (between 3 and 5 times), severe (more than 5 times)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 4 cc of 2% lidocaine are apply directly into the carina just before suctioning the trachea.
Category
Prevention
2
Description
Control group: 4 cc of 0.9% Normal saline are apply directly into the carina just before suctioning the trachea.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajaei cardiovascular center
Full name of responsible person
Hoda Abedi
Street address
Rajaei Heart Center,Valiasr St
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Email
abedi.hoda.ha@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rajaei Heart Center
Full name of responsible person
Fateme Shima Hadipoorzade
Street address
Rajaei Heart Center,Valiasr St
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Email
shimahadipoorzadeh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rajaei Heart Center
Proportion provided by this source
20
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
2
Sponsor
Name of organization / entity
Rajaei Heart Center
Full name of responsible person
Hoda Abedi
Street address
Rajaei Heart Center,Valiasr St
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Email
abedi.hoda.ha@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Hoda Abedi
Proportion provided by this source
80
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Rajaei Heart Center
Full name of responsible person
Hoda Abedi
Position
Master student of intensive care nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Rajaei Heart Center,Valiasr St
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2392 3312
Fax
Email
abedi.hoda.ha@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Rajaei Cardiovascular Research and Therapeutic Training Center
Full name of responsible person
Hoda Abedi
Position
Master student of intensive care nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Rajaei Heart Center,Valiasr St
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2392 3312
Fax
Email
abedi.hoda.ha@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Rajaei Cardiovascular Research and Therapeutic Training Center
Full name of responsible person
Hoda Abedi
Position
Master student of intensive care nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Rajaei Heart Center,Valiasr St
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2392 3312
Fax
Email
abedi.hoda.ha@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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Shared through email
When the data will become available and for how long
Access period starts 1year after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
unlimited
From where data/document is obtainable
through email abedi.hoda.ha@gmail.com
What processes are involved for a request to access data/document