Protocol summary

Study aim
Since no previous studies have compared the efficacy of dexamethasone and lidocaine in preventing the incidence of respiratory complications after extubation in children with a history of reactive airways, this study sought to compare the effects of these two drugs in decreasing the mentioned complications in children with reactive airways.
Design
This randomized double-blind clinical trial will conduct at Imam Hossein Pediatric Hospital
Settings and conduct
The double-blind design will ensure by keeping the patient, the person who injected the medicines, and the data collector unaware of the group allocations.
Participants/Inclusion and exclusion criteria
healthy one-six-year-old ASA I/ASA II candidates of inguinal hernia repair who had a history of reactive airways or cold symptoms in the past six weeks were included. The exclusion criteria were fever, productive cough, rhonchi in lung auscultation, prolonged surgery (longer than one hour), bleeding, and any complications of the surgery.
Intervention groups
An anesthesiologist prepar equal volumes of medications in similar syringes. Before the induction of anesthesia by the nurse, the first, second, and third groups receive intravenous dexamethasone (0.2 mg/kg), intravenous lidocaine (1 mg/kg), and placebo (normal saline with similar volume),
Main outcome variables
After patient transfer to the post-anesthesia care unit (PACU), the researcher record SPO2, MAP, heart rate, and respiratory complications (cough, laryngospasm, bronchospasm, every 15 minutes. Moreover, the same parameters will evaluate every two hours during the first six hours of the patient’s stay in the ward.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160301026866N5
Registration date: 2018-06-20, 1397/03/30
Registration timing: prospective

Last update: 2018-06-20, 1397/03/30
Update count: 0
Registration date
2018-06-20, 1397/03/30
Registrant information
Name
Amir Shafa
Name of organization / entity
Isfahan University of Medical Sciences, Imam hossein Hospital
Country
Iran (Islamic Republic of)
Phone
+98 31 3627 2655
Email address
amir_shafa@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study on the efficacy of intravenous dexamethasone and lidocaine in reducing respiratory complications after general anesthesia in children with a history of reactive airways
Public title
A comparative study on the efficacy of intravenous dexamethasone and lidocaine in reducing respiratory complications after general anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
healthy one-six-year-old ASA I/ASA II candidates of inguinal hernia repair who had a history of reactive airways or cold symptoms in the past six weeks were included.
Exclusion criteria:
fever, productive cough, rhonchi in lung auscultation
Age
From 1 year old to 6 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
ُSimple Random Allocation
Blinding (investigator's opinion)
Double blinded
Blinding description
The double-blind design was ensured by keeping the patient, the person who injected the medicines, and the data collector unaware of the group allocations
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics commottee of Isfahan University Of Medical Sciences
Street address
Hezarjerib Ave.
City
Isfahan
Province
Isfehan
Postal code
8185665843
Approval date
2016-06-25, 1395/04/05
Ethics committee reference number
ir.mui.rec.1395.3.94975

Health conditions studied

1

Description of health condition studied
respiratory complications after general anesthesia
ICD-10 code
J40
ICD-10 code description
J20

Primary outcomes

1

Description
SPO2, respiratory complications (cough, laryngospasm, bronchospasm)
Timepoint
every 15 minutes in the ricovery room and every two hours during the first six hours of the patient’s stay in the ward
Method of measurement
Pulse Oximeter

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Before the induction of anesthesia by the nurse, the first, second, and third groups received intravenous dexamethasone (0.2 mg/kg), intravenous lidocaine (1 mg/kg), and placebo (normal saline with similar volume), respectively.
Category
Treatment - Drugs

2

Description
Control group:placebo(normal saline)with similar volume
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Hossein Hospital
Full name of responsible person
Amir Shafa
Street address
Emam Hossein Hospital,Emam Khomeini Ave.
City
Isfahan
Province
Isfehan
Postal code
8185665843
Phone
+98 31 3386 9141
Email
amir_shafa@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
Hezarjerib Ave.
City
Isfahan
Province
Isfehan
Postal code
8185665843
Phone
+98 31 3668 8138
Email
sh_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
Amir Shafa
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Emam Hossein Hospital, Emam Khomeini Ave
City
Isfahan
Province
Isfehan
Postal code
8185665843
Phone
+98 31 3773 5509
Email
amir_shafa@med.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
amir shafa
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Emam Hossein Hospital, Emam khomeini Ave
City
Isfahan
Province
Isfehan
Postal code
8185665843
Phone
+98 31 3773 5509
Email
amir_shafa@med.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amir Shafa
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Emam Hosein Hospital, Emam khomeini Ave
City
Isfahan
Province
Isfehan
Postal code
8185665843
Phone
+98 31 3773 5509
Email
amir_shafa@med.mui.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
Yes - There is a plan to make this available
Title and more details about the data/document
All files
When the data will become available and for how long
6 Month after print results
To whom data/document is available
All peoples
Under which criteria data/document could be used
There are no special conditions
From where data/document is obtainable
Amir Shafa Email: amir_shafa@med.mui.ac.ir
What processes are involved for a request to access data/document
Request via email
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