Cardiovascular effects Add epinephrine to local anesthetics in children under the caudal epidural block for subumbilical surgery.
Design
People will be divided into two groups according to a random number table
Settings and conduct
A total of 60 children under the age of six years undergoing general anesthesia undergoing cervical cancer surgery. People will be divided into two groups according to random numbers. Drug syringes are being prepared by the anesthetic professors of the children. Drugs for blocking will be done by children's anesthetic flashing.
Participants/Inclusion and exclusion criteria
Children under the age of six years undergoing subumblical surgery (including lower abdominal surgery and urinary tract) under general anesthesia
Intervention groups
Cardiovascular effects in patients with caudal block with local anesthetic and epinephrine
Main outcome variables
ECG Variation,pulse Rate,blood Presuer.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100527004041N15
Registration date:2018-07-12, 1397/04/21
Registration timing:registered_while_recruiting
Last update:2018-07-12, 1397/04/21
Update count:0
Registration date
2018-07-12, 1397/04/21
Registrant information
Name
Mahin Seyedhejazi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3385 2252
Email address
seidhejazie@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2018-09-22, 1397/06/31
Actual recruitment start date
2018-03-21, 1397/01/01
Actual recruitment end date
2018-09-22, 1397/06/31
Trial completion date
empty
Scientific title
Cardiovascular effects of adding epinephrine to local anesthetics in children under the caudal epidural block for subumbilical surgery
Public title
cardiovascular effects of epinephrine in pediatric caudal block
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children under the age of 6 years undergoing sub umbilical surgery ;;
Exclusion criteria:
Children aged 6 or older
Surgeries that can not be used with a caudal block
Age
From 1 year old to 6 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Accidental randomization to intervention groups and control groups,
Patients, the person responsible for recording vital signs and the person analyzing the data will be unaware of the addition or not of an epinephrine.
Blinding (investigator's opinion)
Double blinded
Blinding description
Pediatric Anesthesia Fellowship and Experienced Anesthetist Nurse will be responsible for measuring these symptoms. Patients are the person responsible for recording vital signs and the person analyzing the data are unaware of whether or not to perform airway suction.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Etics committee of Tabriz University of Medical Sciences
Street address
Golgasht Ave,Tabriz University of Medical scince
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2018-03-17, 1396/12/26
Ethics committee reference number
IR.TBZMED.REC.1396.1236
Health conditions studied
1
Description of health condition studied
Patients undergo subumblical surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
ECG Exchange
Timepoint
Measurement of heart rate Blood pressur and ECG in minutes are 0, 1, 5, and 20
Method of measurement
Measurement by Digital Beatitude Monitor
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: A group of children aged from one to six years undergoing subumblical surgery which is used to treat post-operative anesthesia of the caudal block, and the epinephrine agent is given as an add-on to local anesthetic drugs.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
2
Recruitment center
Name of recruitment center
Tabriz Children Hospital
Full name of responsible person
Mahin .Seidhejazie
Street address
Sheshgelan Ave,Tabriz Children Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
57147_83732
Phone
+98 41 3526 2262
Email
seidhejazie@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahmoodpoor.ata
Street address
Golgasht Ave.Tabriz Univercity of Medical Since
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2262
Email
info@medfac.tbzmed.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Tohid.Karami
Position
Fellowship of Pediatric Anesthesia
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Sheshgelan Ave,Tabriz Childeren Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2262
Email
karami.tohid@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahin.Seidhejazie
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Pediatric Anesthesia
Street address
Sheshgelan Ave,Tabriz Childeren Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2262
Email
seidhejazie@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahin.Seidhejazie
Position
professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatric Anesthesia
Street address
Sheshgelan Ave, Tabriz Childeren Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
57147_83724
Phone
+98 41 3526 6911
Email
seidhejazie@tbzmed.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
No - There is not 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
We are going to publish all in paper
When the data will become available and for how long
In the end of study
To whom data/document is available
Every one who read the paper
Under which criteria data/document could be used
If the data is needed to be used for further analysis, only the study designer has access to the codes and patients information. If the data is going to be used in another study, a proposal (in which the goals of study are established) should be registered and ethics code must be received.
From where data/document is obtainable
From the paper
What processes are involved for a request to access data/document