Determination and Comparison of the effect of Intracuff Alkalinized Lidocaine versus IV Lidocaine on Coughing and Postoperative Sore Throat
Design
Randomized controlled double blinded clinical trial on 99 patients undergoing intubation. Patients were randomly divided into three groups with Simple randomization by Random Allocation Software.
Settings and conduct
A randomized clinical. The population of study were 99 patients from Kashani hospital .The study was conducted between 2017 and 2018.
The method of blinding was used to prevent patients from being aware of the substance used during intubation, samples were collected by an anesthetist unaware of the type of used anesthetic agents and also administration of drugs was done by another anesthetist.
Participants/Inclusion and exclusion criteria
Patients with ASA I or ASA II
Patients aged 18 to 65 years
Patients who were candidates for Elective Surgery under General Anesthesia requiring Tracheal Intubation
were enrolled in the study.
Patients with Underlying Conditions including Uncontrolled Diabetes, Uncontrolled Hypertension, Asthma
Patients with Hyper-Reactive Airway Disease
Patients with history of Lidocaine Susceptibility
Patients with Chronic Cough and Sore Throat
were considered as exclusion criteria.
Intervention groups
Intracuff alkalinized lidocaine group: The cuff of endotracheal tube was slowly filled with air then 2 ml of lidocaine was injected into the cuff. Finally, an additional volume of NaHCo3 8.4% was injected into the cuff.
intravenous lidocaine group: The cuff of endotracheal tube was filled with air, at the end of the surgery and after extubation 1.5 mg/kg lidocaine was injected intravenously.
Control group: The cuff of endotracheal tube was filled only with air to the pressure of 30 cmH2o.
Main outcome variables
Changing in frequency of cough after intubation; Changing in severity of sore throat after intubation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090129001615N3
Registration date:2019-11-04, 1398/08/13
Registration timing:retrospective
Last update:2019-11-04, 1398/08/13
Update count:0
Registration date
2019-11-04, 1398/08/13
Registrant information
Name
Azim Honarmand
Name of organization / entity
Alzahra hospital
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 0048
Email address
honarmand@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-10-01, 1396/07/09
Expected recruitment end date
2018-10-01, 1397/07/09
Actual recruitment start date
2017-10-01, 1396/07/09
Actual recruitment end date
2018-10-01, 1397/07/09
Trial completion date
2018-10-01, 1397/07/09
Scientific title
Evaluation and Comparison of Intracuff Alkalinized Lidocaine versus Intravenous Lidocaine effects on Coughing and Postoperative Sore throat
Public title
Evaluation and Comparison of the effect of Intracuff Alkalinized Lidocaine versus Intravenous Lidocaine on Coughing and Sore throat after Surgical Operation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with ASA I or ASA II
Patients aged 18 to 65 years
Patients who were candidates for Elective Surgery under General Anesthesia requiring Tracheal Intubation
Exclusion criteria:
Patients with Underlying Conditions including Uncontrolled Diabetes, Uncontrolled Hypertension, Asthma
Patients with Hyper-Reactive Airway Disease
Patients with history of Lidocaine Susceptibility
Patients with Chronic Cough and Sore Throat
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
99
Actual sample size reached:
99
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with Random Allocation Software
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient is not aware of the Substance used during Intubation.
Samples were collected by an Anesthetist unaware of the type of used Anesthetic Agents. (Administration of drugs was done by another Anesthetist.)
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezarjerid Ave.
City
Isfahan
Province
Isfehan
Postal code
7346181746
Approval date
2016-06-16, 1395/03/27
Ethics committee reference number
ir.mui.rec.1395.3.972
Health conditions studied
1
Description of health condition studied
Coughing after intubation
ICD-10 code
R05
ICD-10 code description
Cough
2
Description of health condition studied
Sore throat after intubation
ICD-10 code
R07.0
ICD-10 code description
Pain in throat
Primary outcomes
1
Description
postoperative Cough frequency
Timepoint
immediately after extubation, within fifteen minutes, one, two, three, twelve and twenty-four hours after extubation.
Method of measurement
Counting Cough Frequency
2
Description
Postoperative Sorethroat
Timepoint
immediately after extubation, within fifteen minutes, one, two, three, twelve and twenty-four hours after extubation.
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intracuff Lidocaine Group, The population of the first group was 33. Initially, in this group, the cuff of endotracheal tube was slowly filled with air until no sound of air leakage was heard and then 2 ml of lidocaine was injected into the cuff. Finally, an additional volume of NaHCo3 8.4% was injected into the cuff to reach the pressure of 30 cmH2o inside.
Category
Treatment - Drugs
2
Description
Intervention group: Intravenous Lidocaine, the cuff of endotracheal tube was filled with air to the pressure of 30 cmH2o with air; then at the end of the surgery and after extubation 1.5 mg/kg lidocaine was injected intravenously.
Category
Treatment - Drugs
3
Description
Control group: the cuff of endotracheal tube was filled only with air to the pressure of 30 cmH2o.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Kashani Hospital
Full name of responsible person
Nazanin Vahedi Nouri
Street address
Kashani Street, Isfahan, Isfahan Province
City
Isfahan
Province
Isfehan
Postal code
۸۱۸۳۹۸۳۴۳۴
Phone
+98 31 3233 0091
Fax
Email
kashani@mui.ac.ir
Web page address
https://kashani.mui.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Azim Honarmand
Street address
Hezar Jerib Ave. Isfahan University of Medical, School of Medicine Sciences,
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 0048
Fax
Email
honarmand@med.mui.ac.ir
Web page address
http://med.mui.ac.ir/
Grant name
Isfahan University of Medical Sciences,Grant
Grant code / Reference number
395972
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Azim Honarmand
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Isfahan University of Medical, School of Medicine Sciences, Hezar Jerib Ave.
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 0048
Email
honarmand@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Azim Honarmand
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
School of Medicine Sciences, Isfahan University of Medical, Hezar Jerib Ave.
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 0048
Email
honarmand@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Azim Honarmand
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
School of Medicine Sciences, Isfahan University of Medical, Hezar Jerib Ave.
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 0048
Email
honarmand@med.mui.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
No more information
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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Main outcome information
When the data will become available and for how long
Since Publication
To whom data/document is available
Researchers working in academic, scientific and industrial institutes
Under which criteria data/document could be used
Statistical analysis
From where data/document is obtainable
honarmand@med.mui.ac.ir Dr.Azim Honarmand
What processes are involved for a request to access data/document
Send email and mention why you need documentation. One to two weeks after sending the request