Evaluation of the effect of intravenous lidocaine and intravenous dexamethasone on respiratory complications after adeno-tonsillectomy surgery and comparison with control group
Determining the effect of lidocaine and intravenous dexamethasone on respiratory complications after adeno-tonsillectomy surgery and comparison with control group
Design
This is a randomized double-blind clinical trial study with parallel groups, phase 3, 90 patients undergoing adeno-tonsillectomy are randomly divided into three groups.
Settings and conduct
This study is conducting from 2018 to 2021 in Isfahan educational hospitals. 90 patients who are candidates for adeno-tonsillectomy surgery enter the study according to the entry and exit criteria and are divided into three groups of lidocaine, dexamethasone and control by random allocation software. Patients and data analysts are not aware of the groups.
Participants/Inclusion and exclusion criteria
Patients are candidates for adeno-tonsillectomy, 4 to 14 years of age and ASA, anesthesia 1 or 2, no upper or lower respiratory tract infection, no history of asthma, no drug allergy, no addiction, change of anesthesia method
Intervention groups
Group 1: Lidocaine infusion 1.5 mg / kg in 15 cc Normal Saline over 10 minutes. Group 2: Dexamethasone infusion 0.2 mg / kg in 15 cc Normal Saline over 10 minutes. Group 3: control
Main outcome variables
Respiratory infections or complications such as cold, stridor, shortness of breath, decreased arterial oxygen saturation, laryngospasm and bronchospasm, intubation time
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200506047322N1
Registration date:2020-07-31, 1399/05/10
Registration timing:retrospective
Last update:2020-07-31, 1399/05/10
Update count:0
Registration date
2020-07-31, 1399/05/10
Registrant information
Name
Sara Goodarziyan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 0048
Email address
sara.goodarziyan@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-17, 1397/07/25
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
2018-10-19, 1397/07/27
Actual recruitment end date
2020-04-19, 1399/01/31
Trial completion date
2020-04-19, 1399/01/31
Scientific title
Evaluation of the effect of intravenous lidocaine and intravenous dexamethasone on respiratory complications after adeno-tonsillectomy surgery and comparison with control group
Public title
Effect of intravenous lidocaine and intravenous dexamethasone on respiratory complications after adeno-tonsillectomy surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All patients are candidates for adeno-tonsillectomy surgery with an age range of 4-14 years and anesthesia ASA 1 or 2
Exclusion criteria:
Active upper respiratory tract infection within two weeks prior to surgery
Active infection of the lower respiratory tract during 5 weeks before surgery
A history of asthma
History of sensitivity to lidocaine and history of sensitivity to dexamethasone
Smoking patient
Age
From 4 years old to 14 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
90
Actual sample size reached:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Participants in the present study were coded. Codes enter Random Allocation Software and divide by randomly blocking method into 2 groups of intervention and the control group with senary blocks and a ratio of 1:1 . In order to conceal the allocation; The groups were placed in similar envelopes in a matte package numbered consecutively. Blocking and preparation of envelopes was performed by a person who is not involved in sampling and data analysis.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Patients have no information about the medication they receive.The information enters the software with the code and the analyst is unaware of the allocation of groups. After finishing and analyzing the data, the codes are opened
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Hezar Jarib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-04-29, 1399/02/10
Ethics committee reference number
IR.MUI.MED.REC.1399.088
Health conditions studied
1
Description of health condition studied
adeno-tonsillectomy
ICD-10 code
J35
ICD-10 code description
Chronic diseases of tonsils and adenoids
Primary outcomes
1
Description
Respiratory complications
Timepoint
Up to 15 minutes per minute after injection of the drug and then every 15 minutes until discharge from recovery
Method of measurement
Airway Irritability Rating Score
Secondary outcomes
1
Description
Hemodynamic disorders
Timepoint
Up to 15 minutes per minute after injection of the drug and then every 15 minutes until discharge from recovery.
Method of measurement
pulse oximeter
2
Description
Recovery time
Timepoint
From the beginning of the drug injection to the end of recovery
Method of measurement
Measuring time (minutes )
Intervention groups
1
Description
Intervention group 1: Lidocaine intravenous infusion of 1.5 mg / kg in 15 cc normal saline within 10 minutes
Category
Prevention
2
Description
Intervention group 2: Dexamethasone intravenous infusion 0.2 mg / kg in 15 cc normal saline within 10 min
Category
Prevention
3
Description
Control group: without any drug
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani Hospital
Full name of responsible person
Kamran Montazeri
Street address
Kashani Street
City
Isfahan
Province
Isfehan
Postal code
8183983434
Phone
+98 31 3233 0091
Email
montazeri@med.mui.ac.ir
2
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Kamran Montazeri
Street address
Shohadaye sofe Boulevard
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 5555
Email
montazeri@med.mui.ac.ir
3
Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Kamran Montazeri
Street address
Imam khomeini Street
City
Isfahan
Province
Isfehan
Postal code
8195163381
Phone
+98 31 3386 6266
Email
montazeri@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
Hezar jarip Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Kamran Montazeri
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hezar jarip Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3669 2174
Email
montazeri@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Kamran Montazeri
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Hezar jarip Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3669 2174
Email
montazeri@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Sara Goodarziyan
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Hezar jarip Street
City
Isfahan
Province
Isfehan
Postal code
81774673461
Phone
+98 31 3668 9801
Email
Sara.goodarziyan@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The information belongs to the government agency.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Because the information belongs to the government agency, it is not possible to share it.
When the data will become available and for how long
no time
To whom data/document is available
nobody
Under which criteria data/document could be used
Under no circumstances
From where data/document is obtainable
No one, nowhere
What processes are involved for a request to access data/document