The effect of intravenous lidocaine on reducing the complications of endotracheal extubation after heart surgery
Design
A clinical trial with a control group of 45 patients in each group, double-blind, is performed using permuted balanced block (block of four) randomization software. In order to observe concealment and blinding at the same time, the random sequence will be converted into composite codes (not group names) and these codes will be provided to the main researcher in closed envelopes. There is no difference between the two groups of drugs and placebo in terms of appearance, volume and type of syringe.
Settings and conduct
In both groups, patients are selected who have weaning and extubation conditions for at least 6 to 12 hours after surgery. 1.5 ml/kg10% iv lidocaine is injected intravenously. In the control group, 1.5 cc/kg of normal intravenous saline will be injected at the same time with the same conditions. The syringes containing lidocaine or normal saline are very similar and are coded by a third party to the nursing shift at random based on the number of patients who submit the study conditions and then determined by them to the patients on time.
Participants/Inclusion and exclusion criteria
In both groups, patients are selected who have weaning and extubation conditions for at least 4 to 12 hours after surgery.the patient should have relatively simple heart surgery involving CABG or only single valve surgery
Intervention groups
In a group, 1.5 ml / weight of 2% intravenous lidocaine is injected intravenously (1.5 cc / weight of syringe containing lidocaine at a dose of 1.5) 10 minutes before the endotracheal tube is removed. In the control group, 1.5 cc/kg of normal serum intravenous saline in terms of weight will be injected at the same time with the same conditions
Main outcome variables
Cough, bronchospasm, changes in BP and HR,side effects of lidocaine injection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211206053291N1
Registration date:2022-02-20, 1400/12/01
Registration timing:registered_while_recruiting
Last update:2022-02-20, 1400/12/01
Update count:0
Registration date
2022-02-20, 1400/12/01
Registrant information
Name
Abdolreza Dayani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2266 3250
Email address
dr.a.dayani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-08, 1400/10/18
Expected recruitment end date
2022-05-22, 1401/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of intravenous lidocaine on reducing the complications of endotracheal intubation after cardiac surgery
Public title
lidocaine effect on extubation
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
simple cardiac surgury(CABG or valvular)
No history of smoking and drug or alcohol addiction during the last 10 years before surgery
No history of any drug or food allergies
All patients took beta-blockers around the operation and in the morning
No history of lung problems (asthma, COPD, etc.) treated with oral or inhaled drugs
Exclusion criteria:
Dangerous arrhythmia during or after surgery
Hemodynamic instability including: cardiac instability (patients treated with epinephrine or levofed at doses above 1.1 μg / kg) and respiratory instability (po2≤60mmhg or pco2≥50) during postoperative time
Bleeding so much that the patient becomes a candidate for reoperation
Injection of lidocaine for any reason after surgery
EF drop after surgery
Use of ECMO or pump balloons after surgery
Age
From 18 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is performed using permuted balanced block (block of four) method. In order to observe concealment and blinding at the same time, the random sequence will be converted into composite codes (not group names) and these codes will be provided to the main researcher in closed envelopes. There is no difference in appearance, volume and type of syringe between the two groups of drugs and placebo
During the study, after opening each envelope, a syringe corresponding to that code is given to the patient.
Blinding (investigator's opinion)
Double blinded
Blinding description
Extubating the pt when the patient is calm and breathing slowly with a spontaneous ventilator mode 1.5 mg / weight of 2% intravenous lidocaine is injected intravenously (1.5 cc / weight of syringe containing lidocaine at a dose of 1.5 ml / cc).In the control group, 1.5 cc of normal serum will be injected intravenously in terms of weight at the same time under the same conditions.Syringes containing lidocaine or normal saline will be exactly the same and will be coded by a third party And delivered to the head of the nursing shift randomly based on the number of patients who have the conditions of study and then injected by them to the patient at a specified time.Heart rate, blood pressure and possible arrhythmia are assessed before and during the injection, 5 minutes after the injection, and finally one minute after the endotracheal tube is removed and 10 minutes after it, and are completed in a special form by the patient's responsible nurse.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Rajaie Cardiovascular Medical and Research Center
Street address
valiasr st,niyayesh highway,shahid rajaei cardiovascular center
City
tehran
Province
Tehran
Postal code
1995614331
Approval date
2021-12-04, 1400/09/13
Ethics committee reference number
IR.RHC.REC.1400.075
Health conditions studied
1
Description of health condition studied
Larangospasm.
ICD-10 code
J95.5
ICD-10 code description
Postprocedural subglottic stenosis
Primary outcomes
1
Description
Cough occurs after extubation
Timepoint
The onset of cough is assessed before and during injection, 5 minutes after injection, and finally one minute after endotracheal tube removal and 10 minutes after
Method of measurement
The incidence of cough is measured by three criteria of cough, which include: 1- no cough or temporary cough following the exit of the endotracheal tube, 2- incidence of cough by breathing, and 3- persistent cough without respiratory stimulation when the endotracheal tube exits up to 10 minutes later. The questionnaire is mentioned
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 45 patients who have weaning and extubation conditions for at least 6 to 12 hours after surgery. For this purpose, the patient should have relatively simple heart surgery involving vascular occlusion (CABG) or only single valve surgery. Also dangerous arrhythmia and instability. Cardiac (patients treated with epinephrine or Levofed at doses above 1.1 / macro / kg) and respiratory (po2≤60mmhg or (pco2≥50) are also excluded from our study Our study enters
Category
Treatment - Drugs
2
Description
Control group: For 45 patients, 1.5 cc/kg of normal intravenous saline will be injected at the same time under the same conditions. Syringes containing lidocaine or normal saline will be exactly the same and will be coded by a third person to the nursing shift randomly based on the number of patients The study is delivered and then injected by the patient at a specific time
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shaheed Rajaie Cardiovascular, Medical & Research Center
Full name of responsible person
Abdolreza Dayani
Street address
Valiasr st,niyayesh highway,shahid rajaei cardiovascular center
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2392 3836
Email
Dr.a.dayani@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rajaie Cardiovascular Medical and Research Center, Iran University of Medical Sciences, Tehran, Iran
Full name of responsible person
majid maleki
Street address
Valiasr st,niyayesh highway,Rajaie Cardiovascular Medical and Research Center
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Email
admin@rhc.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rajaie Cardiovascular Medical and Research Center, Iran University of Medical Sciences, Tehran, Iran
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
Iran University of Medical Sciences
Full name of responsible person
Abdolreza Dayani
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr ave,shahid rajaei cardivascular hospital
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2266 3250
Fax
Email
dr.a.dayani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Abdolreza Dayani
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr ave,shahid rajaei cardivascular hospital
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2266 3250
Fax
Email
dr.a.dayani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Abdolreza Dayani
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr ave,shahid rajaei cardivascular hospital
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2266 3250
Fax
Email
dr.a.dayani@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available