The aim of this study is evaluation of nebulized lidocaine 2% in patients sedation during awake intubation.
Design
A phase 3 randomized clinical trial with 55 patients
Settings and conduct
Patients will receive 2% nebulized lidocaine with a dose of 3 mg/kg and 6 Lit/min flow rate for 10 minutes. After 5 minutes, the intubation will be done. Determine the depth of sedation will be done in 3 minutes after sedation with midazolam and 10 min after nebulized lidocaine 2% by BIS index monitoring.
Participants/Inclusion and exclusion criteria
Inclusion criteria are candidates to undergo intubation in awake, history of difficult intubations, patients over 14 years of age and below 70 years.
Exclusion criteria are patient's lack of cooperation (if the awake intubation is not essential), history of liver and kidney disease and coagulation, pathology of the respiratory tract, pregnancy, patients who have long received opioid or sedative medications and aspiration and regurgitation probability.
Intervention groups
The intervention group is patients who receive nebulized lidocaine 2%.
Main outcome variables
The sedation of patients in awake intubation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180806040724N2
Registration date:2019-01-01, 1397/10/11
Registration timing:prospective
Last update:2019-01-01, 1397/10/11
Update count:0
Registration date
2019-01-01, 1397/10/11
Registrant information
Name
Abbasali Dehgan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3336 6777
Email address
dehghania@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-08, 1397/10/18
Expected recruitment end date
2019-09-22, 1398/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of nebulized lidocaine 2% in patients sedation during awake intubation
Public title
The effect of nebulized lidocaine 2% in patients sedation during awake intubation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who candidates undergoing awake intubation
History of difficult intubations
Patients over 14 years and below 70 years
Exclusion criteria:
Lack of cooperation (if the awake intubation is not essential)
History of liver and kidney disease and coagulation
Pathology of the respiratory tract
Pregnancy
Patients who have long received opioid or sedative medications
Aspiration and regurgitation probability
Age
From 14 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
55
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences Ethics Committee
Street address
Golgasht Ave.
City
Tabriz
Province
West Azarbaijan
Postal code
5166614756
Approval date
2018-12-03, 1397/09/12
Ethics committee reference number
IR.TBZMED.REC.1397.731
Health conditions studied
1
Description of health condition studied
Inhalation sedation
ICD-10 code
Y48.0
ICD-10 code description
Inhaled anaesthetics
Primary outcomes
1
Description
Depth of sedation
Timepoint
3 minutes after sedation with midazolam and 10 minutes after inhalation of lidocaine nebulizer 2%
Method of measurement
Bispecteral (BIS) index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Nebulized lidocaine 2% with a dose of 3 mg/kg and 6 Lit/min flow rate for 10 minutes
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Parya Arad
Street address
Golgasht Ave.
City
Tabriz
Province
West Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 7054
Email
info@imamreza.tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jouyban
Street address
Golgasht Ave.
City
Tabriz
Province
West Azarbaijan
Postal code
5166614756
Phone
+98 41 3336 4667
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Parya Arad
Position
Medical doctor
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Golgasht Ave.
City
Tabriz
Province
West Azarbaijan
Postal code
5166614756
Phone
+98 41 3337 6925
Email
paryaarad92@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abbasali Dehghani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of anesthesiology, Faculty of medicine, Golgasht Ave.
City
Tabriz
Province
West Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 1994
Email
dehghania@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abbasali Dehghani
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of anesthesiology, faculty of medicine, Gogasht Ave.
City
Tabriz
Province
West Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 1994
Email
dehghania@tbzmed.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
Primary outcome
When the data will become available and for how long
Starting 6 month after publication
To whom data/document is available
All people
Under which criteria data/document could be used
Use is not allowed.
From where data/document is obtainable
Abbasali Dehghani
What processes are involved for a request to access data/document