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Comparison of the convenience of tracheal extubation between two methods of filling the endotracheal cuff with lidocaine 2% and air in patients undergoing laparoscopic cholecystectomy

Protocol summary

Study aim
The aim of this study is to compare the convenience of tracheal extubation between two methods of filling the Endotracheal Tube cuff with Lidocaine 2% and air in patients undergoing laparoscopic cholecystectomy.
Design
In this single-blind, two-arm, parallel-group controlled trial, 70 patients undergoing elective laparoscopic cholecystectomy will be randomly divided into two groups of filling the endotracheal tube cuff with lidocaine and air, given their documents number .
Settings and conduct
The study will be conducted in the operation room of Qazvin Velayat hospital. 0.02 mg/kg of midazolam and 2μg/kg of fentanyl will be used for premedication, 2mg/kg of propofol 1% will be used for induction of anesthesia and 0.5 mg/kg of atracurium will be used as muscle relaxant. In the Lidocaine group, the endotracheal tube cuff will be filled with lidocaine 2% and in the Air group, the cuff will be filled with air until the pressure reaches between 20 and 25 cm H2O. None of the patients were aware of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria will be female gender; age between 20 and 60; and class 1&2 of the American Society of Anesthesiologists (ASA) Classification. Exclusion criteria will be heart block or heart failure; unstable hemodynamics; depression; kidney or liver failure; lidocaine sensitivity; tracheal deformity; and lack of consent to partipate in study.
Intervention groups
Intervention and control groups includes patients under general anesthesia receiving intervention of filling the endotracheal tube cuff with lidocaine and air respectively.
Main outcome variables
Study outcomes will be patient's blood pressure and heart rate before induction of anesthesia, 30 and 60 minutes after induction, and before and after extubation; complications of intubation, including bucking, coughing and sore throat during recovery, 6 and 12 hours later.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150803023473N5
Registration date: 2020-01-06, 1398/10/16
Registration timing: retrospective

Last update: 2020-01-06, 1398/10/16
Update count: 0
Registration date
2020-01-06, 1398/10/16
Registrant information
Name
Siamak Yaghuobi
Name of organization / entity
Qazvin University of Medical Sciences & Health Services
Country
Iran (Islamic Republic of)
Phone
+98 28 3376 0620
Email address
syaghoubi@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
2019-01-21, 1397/11/01
Actual recruitment end date
2019-03-20, 1397/12/29
Trial completion date
2019-03-20, 1397/12/29
Scientific title
Comparison of the convenience of tracheal extubation between two methods of filling the endotracheal cuff with lidocaine 2% and air in patients undergoing laparoscopic cholecystectomy
Public title
Effect of filling of endotracheal tube cuff with Lidocaine on complications of postoperative extubation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Female Gender Age between 20 to 60 Class 1 & 2 of the American Society of Anesthesiologists (ASA) Classification
Exclusion criteria:
Heart block Heart Failure Unstable hemodynamics Depression Kidney or liver failure Sensitivity to Lidocaine Tracheal deformity Lack of consent to participate in the study
Age
From 20 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 70
Actual sample size reached: 70
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients will not be aware of the way of endotracheal tube filling during anesthesia, so this study is considered a single-blind study.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Qazvin University of Medical Sciences
Street address
Bahonar Blvd.
City
Qazvin
Province
Qazvin
Postal code
3419915315
Approval date
2018-12-31, 1397/10/10
Ethics committee reference number
IR.QUMS.REC.1397.274

Health conditions studied

1

Description of health condition studied
Sore throat after endotracheal intubation
ICD-10 code
Y70
ICD-10 code description
Anaesthesiology devices associated with adverse incidents

Primary outcomes

1

Description
Blood pressure
Timepoint
Before induction of anesthesia, 30 and 60 minutes after induction, and before and after extubation.
Method of measurement
Blood Pressure Cuff (Sphygmomanometer)

2

Description
Heart rate
Timepoint
Before induction of anesthesia, 30 and 60 minutes after induction, and before and after extubation.
Method of measurement
Cardiac monitoring device

Secondary outcomes

1

Description
Coughing
Timepoint
During recovery, 6 hours and 12 hours after recovery
Method of measurement
Patient self-reporting

2

Description
Bucking
Timepoint
During recovery, 6 hours and 12 hours after recovery
Method of measurement
Patient self-reporting

3

Description
Sore throat
Timepoint
During recovery, 6 hours and 12 hours after recovery
Method of measurement
Patient self-reporting

Intervention groups

1

Description
Intervention group: In the Lidocaine group, the endotracheal tube cuff will be filled with lidocaine 2% until the pressure reaches between 20 and 25 cm H2O.
Category
Prevention

2

Description
Control group: In the Air group, the cuff will be filled with air until the pressure reaches between 20 and 25 cm H2O.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Qazvin Velayat hospital
Full name of responsible person
Siamak Yaghoubi
Street address
Taavon Square, 22 Bahman Blvd., Minoodar Town
City
Qazvin
Province
Qazvin
Postal code
3419915315
Phone
+98 28 3379 0620
Fax
+98 28 3379 0611
Email
syaghoubi@qums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Amir Peymani
Street address
Bahonar Blvd.
City
Qazvin
Province
Qazvin
Postal code
3419915315
Phone
+98 28 3333 6001
Email
syaghoubi@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Karan Samimi
Position
Resident of anesthesiology
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Bahonar Blvd,.
City
Qazvin
Province
Qazvin
Postal code
3419915315
Phone
+98 28 3333 6001
Fax
Email
karansamimi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Siamak Yaghoubi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Bahonar Blvd,.
City
Qazvin
Province
Qazvin
Postal code
3419915315
Phone
+98 28 3333 6001
Email
syaghoubi@qums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Karan Samimi
Position
Resident of anesthesiology
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Bahonar Blvd,.
City
Qazvin
Province
Qazvin
Postal code
3419915315
Phone
+98 28 3333 6001
Email
karansamimi@yahoo.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
All data can be shared after participants are unidentified.
When the data will become available and for how long
Start of access period from 1398
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
In order to further study on the available data
From where data/document is obtainable
Dr. Karan Samimi karansamimi@yahoo.com
What processes are involved for a request to access data/document
Obtaining permission from Research Deputy of Qazvin University of Medical Sciences
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