A comparative study on the effect of intravenous administration of Lidocaine and Dexamethasone on the prevention of Fentanyl induced cough in the induction of anesthesia in children under general anesthesia
Comparison of Dexamethasone and Lidocaine Effects on Coughing Reduction after Fentanyl Injection In General Anesthesia
Design
The present study is a double-blind randomized clinical trial with parallel control group.The first group will receive 1 mg / kg of intravenous lidocaine five minutes before administration of fentanyl.The second group will receive 0.2 mg / kg of dexamethasone five minutes before administration of fentanyl.The control group will receive the same volume of normal saline 0.9% five minutes prior to the administration of fentanyl.
Settings and conduct
This study is carried out in Isfahan Imam Hossein Children's Hospital.All patients received intravenous midazolam 0.1 mg / kg and will be taken in the operating room.Five minutes before receiving anesthesia, they receive the drug (lidocaine / dexamethasone / normal saline).Medications are delivered by the researcher in equal volumes and anesthetist who inject drugs and patients are blinded from groups .
Participants/Inclusion and exclusion criteria
inclusion criteria: Children from six months to two years, ASAI ,ASAII, Surgical candidate under general anesthesia.
Exclusion criteria: Symptoms of colds in the last two week, History of reactive airway disease,The probability of difficult intubation
Intervention groups
The first group will receive 1 mg / kg of intravenous lidocaine five minutes before administration of fentanyl.The second group will receive 0.2 mg / kg of dexamethasone five minutes before administration of fentanyl.The third group will receive the same volume of normal saline 0.9% five minutes prior to the administration of fentanyl.
Main outcome variables
Incidence and severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160301026866N10
Registration date:2018-12-02, 1397/09/11
Registration timing:registered_while_recruiting
Last update:2018-12-02, 1397/09/11
Update count:0
Registration date
2018-12-02, 1397/09/11
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
2018-10-02, 1397/07/10
Expected recruitment end date
2019-01-30, 1397/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study on the effect of intravenous administration of Lidocaine and Dexamethasone on the prevention of Fentanyl induced cough in the induction of anesthesia in children under general anesthesia
Public title
A comparative study on the effect of intravenous administration of Lidocaine and Dexamethasone on the prevention of Fentanyl induced cough in the induction of anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children from six months to two years, ASAI ,ASAII, Surgical candidate under general anesthesia
Exclusion criteria:
Symptoms of colds in the last two week, History of reactive airway disease,The probability of difficult intubation
Age
From 6 months old to 2 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
121
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization method Using the random number table
Blinding (investigator's opinion)
Double blinded
Blinding description
Medications are delivered by the researcher in equal volume, Encoded, Anesthesiologist who inject drugs and patients from groups is not known
Placebo
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
Hezarjrib Ave, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8185665843
Approval date
1997-09-01, 1376/06/10
Ethics committee reference number
ir.mui.rec.1396.3.371
Health conditions studied
1
Description of health condition studied
Fentanyl-induced coughing
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
incidence and Severity of coughing
Timepoint
One minute after prescribing the drug, One minute after the administration of fentanyl
Method of measurement
Standard questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Five minutes before prescribing fentanyl, 1 cc normal saline will receive .
Category
Treatment - Drugs
2
Description
Intervention group1: 5 minutes before administration of fentanyl, 1 mg / kg intravenous lidocaine will receive .
Category
Treatment - Drugs
3
Description
Intervention group2: 5 minutes before administration of fentanyl, 0.2 mg / kg intravenous Dexamethasone will receive .
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam hossein Children Hospital
Full name of responsible person
Amir shafa
Street address
Emam Khomeini Ave, Emam Hossein Hospital
City
Isfahan
Province
Isfehan
Postal code
8185665843
Phone
+98 31 3773 5509
Email
shafa_amir@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shghayegh haghjoy
Street address
Hezarjrib Ave, Isfahan University of Medical Sciences
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 khomeini Ave, Emamhossein Hospital
City
Isfahan
Province
Isfehan
Postal code
81856665843
Phone
+98 31 3773 5509
Email
shafa_amir@yahoo.com
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 khomeini Ave, Emamhossein Hospital
City
Isfahan
Province
Isfehan
Postal code
8185665843
Phone
+98 31 3773 5509
Email
shafa_amir@yahoo.com
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
Emamkhomeini Ave, Emamhossein Hospital
City
Isfahan
Province
Isfehan
Postal code
8185665843
Phone
+98 31 3773 5509
Email
shafa_amir@yahoo.com
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
The total potential data can be shared after unidentifiable people
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Access for everyone is free
Under which criteria data/document could be used
There are no special conditions.
From where data/document is obtainable
Amir Shafa: shafa_amir@yahoo.com
What processes are involved for a request to access data/document