A comparative study on the effect of intravenous dexamethasone and intravenous lidocaine on reduction of hemodynamic and respiratory complications in children undergoing cleft palate surgery
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General information
2018-08-23, 1397/06/01
2018-09-20, 1397/06/29
2018-0809-2320 00:00:00
2019-03-19, 1397/12/28
2019-01-20, 1397/10/30
2019-0301-1920 00:00:00
Simple randomization using random numbers table
Randomization with using Permuted block randomization, For this purpose, use 6-unit blocks. We start randomly from the number 4480 in the random number table And up to 7045, we will code a total of 18 blocks of 6 by the table.
Simple randomizationRandomization with using Permuted block randomization, For this purpose, use 6-unit blocks. We start randomly from the number 4480 in the random numbersnumber table And up to 7045, we will code a total of 18 blocks of 6 by the table.
تصادفی سازی ساده با استفاده از جدول اعداد تصادفی
تصادفی سازی با استفاده از تصادفی سازی بلوکی انجام می شود، برای این منظور از بلوک های6 تایی استفاده می کنیم ، بصورت تصادفی از عدد 4480 در جدول اعداد تصادفی شوع کرده و تا عدد 7045 مجموعا 18 بلوک 6 تایی بوسیله جدول کد می دهیم.
تصادفی سازی ساده با استفاده از تصادفی سازی بلوکی انجام می شود، برای این منظور از بلوک های6 تایی استفاده می کنیم ، بصورت تصادفی از عدد 4480 در جدول اعداد تصادفی شوع کرده و تا عدد 7045 مجموعا 18 بلوک 6 تایی بوسیله جدول کد می دهیم.
Recruitment centers
#1
Name of recruitment center - English: Emamhossein hospital
Name of recruitment center - Persian: بیمارستان امام حسین
Full name of responsible person - English: Amir Shafa
Full name of responsible person - Persian: امیر شفا
Street address - English: Emamhossein hospital, Emamkhomeini Ave
Street address - Persian: بیمارستان امام حسین، خیابان امام خمینی
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8185665843
Phone: +98 31 3773 5509
Fax:
Email: shafa_amir@yahoo.com
Web page address:
Name of recruitment center - English: Imam Hossein hospital
Name of recruitment center - Persian: بیمارستان امام حسین
Full name of responsible person - English: Amir Shafa
Full name of responsible person - Persian: امیر شفا
Street address - English: Imam Hossein hospital, Imam Khomeini Ave
Street address - Persian: بیمارستان امام حسین، خیابان امام خمینی
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8185665843
Phone: +98 31 3773 5509
Fax:
Email: shafa_amir@yahoo.com
Web page address:
Name of recruitment center - English: EmamhosseinImam Hossein hospital Name of recruitment center - Persian: بیمارستان امام حسین Full name of responsible person - English: Amir Shafa Full name of responsible person - Persian: امیر شفا Street address - English: EmamhosseinImam Hossein hospital, EmamkhomeiniImam Khomeini Ave Street address - Persian: بیمارستان امام حسین، خیابان امام خمینی City - English: Isfahan City - Persian: اصفهان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 8185665843 Phone: +98 31 3773 5509 Fax: Email: shafa_amir@yahoo.com Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Shaghayegh haghjoy
Full name of responsible person - Persian: شقایق حق جوی
Street address - English: Hezarjrib Ave, Isfahan University of Medical Sciences
Street address - Persian: دانشگاه علوم پزشکی اصفهان، خیابان هزار جریب
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8185665843
Phone: +98 31 3668 8138
Fax:
Email: sh_haghjoo@med.mui.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Shaghayegh Haghjoy
Full name of responsible person - Persian: شقایق حق جوی
Street address - English: Isfahan University of Medical Sciences, Hezarjrib street
Street address - Persian: دانشگاه علوم پزشکی اصفهان، خیابان هزار جریب
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8185665843
Phone: +98 31 3668 8138
Fax:
Email: sh_haghjoo@med.mui.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Shaghayegh haghjoyHaghjoy Full name of responsible person - Persian: شقایق حق جوی Street address - English: Hezarjrib Ave, Isfahan University of Medical Sciences, Hezarjrib street Street address - Persian: دانشگاه علوم پزشکی اصفهان، خیابان هزار جریب City - English: Isfahan City - Persian: اصفهان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 8185665843 Phone: +98 31 3668 8138 Fax: Email: sh_haghjoo@med.mui.ac.ir Web page address:
Protocol summary
Study aim
The effect of intravenous dexamethasone and lidocaine on reduction of respiratory and hemodynamics complications after general anesthesia in children undergoing cleft palate surgery.
Design
This study is a randomized double-blind, clinical trial with parallel groups.
Settings and conduct
This study will be carried out among patients undergoing cleft palate surgery at Imam Hossein Hospital in Isfahan, Iran, in 2018 .The drugs are in equal volumes and are encrypted in the same syringes. In addition the syringes will be coded. These jobs will be do to keep blinding. Patients, researcher and nurse-recorder do not know which group the patients are allocated to.
Participants/Inclusion and exclusion criteria
Inclusion criteria : candidates of cleft palate repair surgery with age range of 6 months old to 2 years old and patients with class I and II in American society of anesthesiologists (ASA) classification.
Exclusion criteria: prolonged surgical time more than 3 hours, post -operative bleeding and post-surgical complication
Intervention groups
The first group received intravenous dexamethasone (0.2 mg / kg), the second group received intravenous lidocaine (1 mg / kg) and the third group received placebo. The drugs were in equal volumes and they were prescribed before induction of anesthesia.
Main outcome variables
Mean arterial blood pressure; Heart rate; Severity of pain; Laryngospasm; Bronchospasm; Cough; Vomiting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160301026866N8
Registration date:2018-09-17, 1397/06/26
Registration timing:prospective
Last update:2019-01-07, 1397/10/17
Update count:1
Registration date
2018-09-17, 1397/06/26
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
2018-09-20, 1397/06/29
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
A comparative study on the effect of intravenous dexamethasone and intravenous lidocaine on reduction of hemodynamic and respiratory complications in children undergoing cleft palate surgery
Public title
Intravenous Dexamethasone and intravenous lidocaine in children undergoing cleft palate surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Six months to two years children
with ASA class I and II
without underlying illness
candidate for Cleft palate surgery
Exclusion criteria:
The presence of symptoms of upper respiratory tract infection
Coagulation disorder
Systemic diseases
other hereditary abnormalities
Age
From 6 months old to 2 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
115
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization with using Permuted block randomization, For this purpose, use 6-unit blocks. We start randomly from the number 4480 in the random number table And up to 7045, we will code a total of 18 blocks of 6 by the table.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients, researcher and nurse-recorder do not know which group the patients are allocated to. Medications are prepared in similar syringes and in equal volumes.
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
Emamhossein Hospital, Emam Khomeini Ave.
City
Isfahan
Province
Isfehan
Postal code
8185665843
Approval date
2015-08-11, 1394/05/20
Ethics committee reference number
Ir.Mui.Rec.1394.3.873
Health conditions studied
1
Description of health condition studied
Respiratory and hemodynamic complications in the cleft palate
ICD-10 code
Q35; Q36;
ICD-10 code description
Cleft palate; Cleft lip; Cleft palate with cleft lip
Primary outcomes
1
Description
Mean arterial blood pressure
Timepoint
Every 15 minutes during surgery and every 15 minutes in recovery room
Method of measurement
Anesthetic monitoring device
2
Description
Heart rate
Timepoint
Every 15 minutes during surgery and every 15 minutes in recovery room
Intervention group 1: Before induction of anesthesia, a recovery nurse will be administered to the first group of intravenous dexamethasone (0.2 mg / kg).
Category
Treatment - Drugs
2
Description
Intervention group 2: Before induction of anesthesia, a recovery nurse will be administered to the second group of intravenous lidocaine (1mg / kg).
Category
Treatment - Drugs
3
Description
Control group: Placebo is given in equal volume.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein hospital
Full name of responsible person
Amir Shafa
Street address
Imam Hossein hospital, Imam Khomeini Ave
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
Shaghayegh Haghjoy
Street address
Isfahan University of Medical Sciences, Hezarjrib street
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
Emamhossein Hospital, Emam khomeini Ave
City
Isfahan
Province
Isfehan
Postal code
8185665843
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
Emamhossein Hospital, Emamkhomeini Ave
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
Emam Hossein Hospital, Emam KHomeini Ave
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
All data is shared
When the data will become available and for how long
6 months after printing results
To whom data/document is available
All researchers
Under which criteria data/document could be used
For scientific research
From where data/document is obtainable
Amir Shafa
What processes are involved for a request to access data/document