Comparison of patient satisfaction during flexible bronchoscopy by local anesthesia done with lidocaine spraying or conjunctive use of airway neural block and lidocaine spraying
Comparison of patient satisfaction during flexible bronchoscopy by local anesthesia done with lidocaine spraying or conjunctive use of airway neural block and lidocaine spraying
Design
Randomized clinical trial , two arm blinded, with a parallel group design will perform and the sample size will be 60 patients
Settings and conduct
Study will perform in Imam Khomeini Hospital of Tehran, patients will divide into two groups. In the first group, local anesthetic will be "spray as you go". In the second group, in addition to the "spray as you go" method, airway nerve block is also done.
Sedation and nerve block will perform by anesthesiologist. The injection site for nerve block is covered in all patients with three small adhesives, thus, the bronchoscopist is not known from the patient group. Patient satisfaction will be measured in the recovery room by the unaware nurse to the patient's group and after the patient's complete consciousness.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Clinical Indication for Diagnostic Bronchoscopy
At least 18 years old
Stable hemodynamic status in the patient
Exclusion criteria:
Pregnancy
Coagulation disorders
Intervention groups
In the first group, local anesthetia will be "spray as you go". In the second group, in addition to the "spray as you go" method, Airway Nerve Block will also done.
Main outcome variables
Patient satisfaction during flexible bronchoscopy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130210012419N3
Registration date:2018-12-14, 1397/09/23
Registration timing:prospective
Last update:2018-12-14, 1397/09/23
Update count:0
Registration date
2018-12-14, 1397/09/23
Registrant information
Name
Mehrnaz Asadi Gharabaghi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61192646
Email address
asadi_m@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-21, 1397/09/30
Expected recruitment end date
2019-01-20, 1397/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of patient satisfaction during flexible bronchoscopy by local anesthesia done with lidocaine spraying or conjunctive use of airway neural block and lidocaine spraying
Public title
Effect of airway neural block on patient satisfaction during bronchoscopy
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnostic Bronchoscopy is clinically indicated
Patients will be older than 18 years old
Stable hemodynamic status
Exclusion criteria:
Patient’s dissatisfaction
Pregnancy
Coagulation disorder and using anticoagulant drugs
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will perform with randomized block design and using of random number table.
Sixty patients will place in 15 blocks. Within each block will be 4 patients, then the numbering of blocks will do using a random number table, in each block two patients belong to the intervention group and two other patients belong to the control group. The layout of the block's people in the two groups (intervention or control group) will be randomized with a random number table. Determination of all possible blocks will be based on the layout of individuals next to each other inside block and the block's number. The entry of individuals to each of the groups will be respectively the block's number choices and the layout in the block.
Blinding (investigator's opinion)
Double blinded
Blinding description
The injection site for the nerve block will cover in all patients in group one and two with three small adhesives, and thus bronchoscopist will not aware of the patient group. Patient satisfaction will be measured in the recovery room and by the unaware nurse to the patient's group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Imam Khomeini Hospital Complex - Tehran University of Science
Street address
Gharib st , Keshavarz Blvd. - Imam Khomeini Hospital Complex
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2018-08-08, 1397/05/17
Ethics committee reference number
IR.TUMS.IKHC.REC.1397.122
Health conditions studied
1
Description of health condition studied
Comparison of patient satisfaction during flexible bronchoscopy by local anesthesia done with lidocaine spraying or conjunctive use of airway neural block and lidocaine spraying
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Patient Satisfaction Scale
Timepoint
After the patient's complete consciousness in the recovery room
Method of measurement
Visual numeric scale
Secondary outcomes
empty
Intervention groups
1
Description
Control group: In control group, local anesthetic agent in form of lidocain solution 1% will be sprayed in certain points so called "spray as you go" method. In this method, 1% lidocaine solution will be sprayed on the vocal cords (4 milliliter), right main bronchus (2 milliliter ) and left main bronchus (2 milliliter) through working channel of bronchoscope. In case of insufficiency and patient discomfort, another 2 milliliter of lidocaine 1% would be sprayed as bolus agent where needed.
Category
Other
2
Description
Intervention group: In the intervention group,Airway Nerve Block(ANB) will be added to the "spray as you go" method, . In ANB, three milliliters of lidocaine 1% will be injected into the cricothyroid membrane (to block recurrent laryngeal nerve ) and another 1.5 milliliters of lidocaine 1% will be utilized on both sides of the neck to block the superior laryngeal nerve.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital - Tehran University of Medical Science