Comparison of nebulizer Method with intratracheal lidocaine injection to reduce pain and cough reflex during bronchoscopy.
Design
Clinical trial with intervention and control groups, 96 patients were randomized with blocking and parallel and non blinded.
Settings and conduct
This study is done in the bronchoscopy unit of the Sabzevar Vasei Hospital. The subjects are anesthetized in one of two ways and then undergo bronchoscopy. The number of coughs is included in the process and at the end of the pain patients are measured at a numerical scale.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
1.Being awake and conscious
2.The ability to collaborate
3.Informed consent
4.Literacy to reading and writing
5.Physical and mental health
6.Ages of 18 to 68 years old
Exclusion criteria:
1.Patients with GCS less than 13
2.Patients with seizure disorders
3.Patients with coagulation abnormalities
4.Patients with a history of lidocaine allergy
5.Patients with history of respiratory tract surgery
6.patients with history of diabetes more than 10 years
7.Drug addiction
8.Previous Bronchoscopy history
Intervention groups
Control group: Patients in this group undergo local anesthesia through the work channel of scope via squirting 10-cc (Split up) lidocaine(lignocaine) ampoule of two percent of the product of the Rasht Pharmaco Company on the vocal cords and lower respiratory tract and then bronchoscopy is done.
Intervention group: : patients in this group, undergo local anaesthesia of respiratory tract by inhaling 10cc of Lidocaine (2%), product of Rasht Farmacoy company, through a nebulizer and then bronchoscopy is done.
Main outcome variables
pain ; cough
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181004041230N1
Registration date:2018-10-30, 1397/08/08
Registration timing:registered_while_recruiting
Last update:2018-10-30, 1397/08/08
Update count:0
Registration date
2018-10-30, 1397/08/08
Registrant information
Name
Saeed Islamitabar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4441 7559
Email address
saeedislamitabar@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-23, 1397/08/01
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of nebulizer Method with intratracheal lidocaine injection to reduce pain and cough reflex during bronchoscopy.
Public title
Comparison of two different local anesthetics, during bronchoscopy.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Being awake and conscious
The ability to collaborate
Informed consent
Literacy to reading and writing
Physical and mental health
Ages of 18 to 68 years old
Exclusion criteria:
Patients with GCS less than 13
Patients with seizure disorders
Patients with coagulation abnormalities
Patients with a history of lidocaine allergy
Patients with history of respiratory tract surgery
patients with history of diabetes more than 10 years
Drug addiction
Previous bronchoscopy history
Age
From 18 years old to 68 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be selected in convenient Sampling method and for restricted randomization, the type of permuted blocks,by using R software, sextet blocks are created and sample people are placed in the intervention or control group.concealment are done with sequentially numbered, sealed, opaque envelopes and kept by the Statistics Consultant.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Sabzevar University of Medical Sciences
Street address
Campus University.,Tohid Shahr Blvd
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617213112
Approval date
2018-09-29, 1397/07/07
Ethics committee reference number
IR.MEDSAB.REC.1397.038
Health conditions studied
1
Description of health condition studied
Respiratory disorder, unspecified
ICD-10 code
J98.9
ICD-10 code description
Respiratory disorder, unspecified
Primary outcomes
1
Description
Pain
Timepoint
At the end of bronchoscopy
Method of measurement
Numerical pain rating scale
2
Description
Cough
Timepoint
During the procedure
Method of measurement
Counting coughs by an assessor
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Patients in this group undergo local anesthesia through the work channel of scope via squirting 10-cc (Split up) lidocaine(lignocaine) ampoule of two percent of the product of the Rasht Pharmaco Company on the vocal cords and lower respiratory tract and then bronchoscopy is done.
Category
Prevention
2
Description
Intervention group: : patients in this group, undergo local anaesthesia of respiratory tract by inhaling 10cc of Lidocaine (2%), product of Rasht Farmacoy company, through a nebulizer and then bronchoscopy is done.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Vasei hospital
Full name of responsible person
Saeed Islamitabar
Street address
Tohid shahr Blvd.,Vasei hospital
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4465 1300
Email
vasei.h@medsab.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Tadayonfar Mosareza
Street address
University campus.,Tohid shahr Blvd
City
sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4401 1300
Email
mtadayonfar@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Saeed Islamitabar
Position
Masters student of intensive care
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
university campus.,Tohid shahr Blvd
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4401 1300
Email
saeedislamitabar@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mosareza Tadayonfar
Position
Master`s Degree
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
University Campus.,Tohid Shahr Blvd
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4401 1300
Email
mtadayonfar@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Saeed Islamitabar
Position
Masters student of intensive care
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
university campus.,Tohid Shahr Blvd
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4401 1300
Email
saeedislamitabar@yahoo.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