Comparative study of fibroptic bronchoscopic with two method: midazolam base versus lidocaine base in patients refered at lung clinic in AJA 501 hospital
Comparative study of fibroptic bronchoscopic with two method: midazolam base versus lidocaine base in patients refered at lung clinic in Imam Reza Hospital 1396-1397
Design
A clinical trial with parallel, double-blind, randomized, black-and-white groups on 140 patients in 2 groups.
Settings and conduct
Lung Clinic of Imam Reza Hospital. In this study, neither the patient nor the collector knew how the samples were distributed. The obtained information is then statistically analyzed by the person in charge of statistical work who does not know how the patients are distributed.
Participants/Inclusion and exclusion criteria
Participants: All male and female patients aged 18 to 80 years and ASA I-II.
Exclusion criteria: include people with a history of sore throat and lung disease with 290% o2sat (hypoxemia) - people with EF˂40% - people with HR˂50 - people with hypotension BP˂90 mmHg -Pregnant or lactating women - People with a long history of taking antipsychotic or sedative drugs.
Intervention groups
Intervention groups: In one group, 3 mg equivalent to 3 ml of midazolam is administered intravenously in a syringe whose volume has been increased to 5 cc by adding 2 cc of distilled water, and in the basal lidocaine group instead of a syringe containing midazolam Containing 5 cc of lidocaine (lidocaine 2%) is used intravenously
Main outcome variables
Type of basic anesthetic (including midazolam and lidocaine)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110103005536N8
Registration date:2020-09-11, 1399/06/21
Registration timing:registered_while_recruiting
Last update:2020-09-11, 1399/06/21
Update count:0
Registration date
2020-09-11, 1399/06/21
Registrant information
Name
Mohamadreza Rafiei
Name of organization / entity
Artesh University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8802 8933
Email address
mo_rafiei@armyums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of fibroptic bronchoscopic with two method: midazolam base versus lidocaine base in patients refered at lung clinic in AJA 501 hospital
Public title
Comparative study of fibroptic bronchoscopic with two method: midazolam base versus lidocaine base
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
male and female patients aged 18 to 80 years
ASA I-II
Exclusion criteria:
People with a history of sore throat and lung disease with 90% o2sat (hypoxemia)
People with Ejection fraction less than 40%
people with hearth rate less than 50
people with hypotension less than 90 mmHg
People with III and grade II conduction blocks
People with liver failure (2-fold increase in liver enzymes) and kidney failure (creatinine more than 2 mg / dL)
Pregnant or lactating women
People With a history of long-term use of antipsychotic drugs or sedatives.
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly assigned between the two groups (70 people in each group) by Simple Random Sampling method using black and white cards, so that patients with black card to group one, and patients with white card to Group two is assigned and this process is repeated again.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, neither the patient nor the collector knew how the samples were distributed. The obtained information is then statistically analyzed by the person in charge of statistical work who does not know how the patients are distributed.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of aja univercity of medical sciences
Street address
Etemadzadeh St., West Fatemi Ave.
City
Tehran
Province
Tehran
Postal code
8158177365
Approval date
2019-04-28, 1398/02/08
Ethics committee reference number
IR.AJAUMS.REC.1398.022
Health conditions studied
1
Description of health condition studied
bronchoscopy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Type of basic anesthetic
Timepoint
Before the intervention
Method of measurement
Based on the name of the drug
Secondary outcomes
1
Description
Complications of bronchoscopy
Timepoint
During the intervention
Method of measurement
Based on the need for intubation, nausea, decreased oxygen saturation, sore throat, cough
2
Description
Duration of bronchoscopy
Timepoint
During the intervention
Method of measurement
Based on time from start to end of the procedure
3
Description
Physician satisfaction
Timepoint
After the intervention
Method of measurement
Based on the doctor's satisfaction with the procedure from 1 to 5 based on likret scale
4
Description
Patient satisfaction
Timepoint
After the intervention
Method of measurement
Based on the patient's satisfaction with the procedure from 1 to 5 based on likret scale
Intervention groups
1
Description
Intervention group: In one group, for performing fibropeptic bronchoscopy, the method of anesthesia is used based on "midazolam". It is administered intravenously and after the fibroptic bronchoscope enters the patient's mouth and before passing through the vocal cords with a syringe with a volume of 5 cc of distilled water is poured on the vocal cords (through the place of fluid entry in the bronchoscope) and then After passing the bronchoscope through the vocal cords, a syringe with a volume of 5 cc of distilled water is poured into the patient's trachea (tracheobronchial tree).
Category
Treatment - Other
2
Description
Intervention group: In one group, for performing fibropeptic bronchoscopy, the method of anesthesia based on "lidocaine" is used. A syringe containing 5 cc of lidocaine (2% lidocaine) is used intravenously and after entering the fibroptic bronchoscope. Patient and before passing the vocal cords with a syringe with a volume of 5 cc lidocaine 2% is poured on the vocal cords (through the place of fluid entry in the bronchoscope) and after passing the bronchoscope through the vocal cords with a syringe With a volume of 5 cc of 2% lidocaine is poured into the patient's trachea (tracheobronchial tree).
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
501 AJA Hospital
Full name of responsible person
Dr. Mohammadreza Rafiei
Street address
Etemadzadeh St., West Fatemi Ave.
City
Tehran
Province
Tehran
Postal code
1411718546
Phone
+98 21 6350 8609
Email
mo_rafiei@armyums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Saeed Soleyman Meygooni
Street address
Etemadzadeh St., West Fatemi Ave.
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 6350 8609
Email
mo_rafiei@armyums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh 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
Artesh University of Medical Sciences
Full name of responsible person
Dr. Mohammadreza Rafiei
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Etemadzadeh St., West Fatemi Ave.
City
Tehran
Province
Tehran
Postal code
8158177365
Phone
+98 31 3261 6302
Email
mo_rafiei@armyums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Dr. Mohammadreza Rafiei
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Etemadzadeh St., West Fatemi Ave.
City
Tehran
Province
Tehran
Postal code
8158177365
Phone
+98 31 3261 6302
Email
mo_rafiei@armyums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Dr Mohammadreza Rafiei
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Etemadzadeh St., West Fatemi Ave.
City
Tehran
Province
Tehran
Postal code
8158177365
Phone
+98 31 3261 6302
Email
mo_rafiei@armyums.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
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
Not applicable
Title and more details about the data/document
All data can be shared after it is unrecognizable
When the data will become available and for how long
Start the access period after printing the results
To whom data/document is available
All researchers and colleagues in this field
Under which criteria data/document could be used
For therapeutic-research purposes and by mentioning the names of the authors of the article
From where data/document is obtainable
Dr. mohammadreza rafiei
What processes are involved for a request to access data/document
Sending an Email to Dr. mohammadreza rafiei and receive data and documentation if needed in the shortest time