Evaluation of hemodynamic changes after caudal anesthesia with intravenous dexamethasone
Design
100 patients that meet the inclusion criteria will be selected .After surgery and when the patient is discharged from anesthesia,the intervention group will receive dexamethasone and the control group will receive distilled water. The study is a randomized, double-blind,placebo-controlled clinical trial.
Settings and conduct
Patients in pediatric hospital operating room will be randomly divided into two groups based on a random number table. The intervention group received 0.5 mg / kg dexamethasone and the control group received 0.5 mg / kg distilled water (similar to dexamethasone) at the start of anesthesia with bupivacaine. Given that the study is double-blind. Both dexamethasone and distilled water (similar to dexamethasone) will be administered to the required number by the planter every morning prior to the start of surgery. Envelope A contains a syringe containing dexamethasone and Envelope B contains distilled water. Each patient will receive these envelopes on the basis of an A or B code, provided by the anesthesiologist who is unaware of the type of drug as the patient is.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Ages between 1to8 years old,candidate for elective lower abdomen surgery
Exclusion criteria:Allergy to Anesthetic Drugs,Allergic to dexamethasone,Previous Neurological Diseases,vertebral column Anomalies
Intervention groups
Intervention group:These patients will receive 0.5mg intravenous dexamethasone while inducing anesthesia with 0.2% bupivacaine at a dose of 1ml/kg.
Control group:This group is similar to the intervention group,only distilled water will be injected with dexamethasone.
Main outcome variables
Evaluation of dexamethasone infusion on hemodynamic changes such as systolic and diastolic blood pressure,MAP,heart rate,petco2 and spo2
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100527004041N20
Registration date:2020-01-02, 1398/10/12
Registration timing:registered_while_recruiting
Last update:2020-01-02, 1398/10/12
Update count:0
Registration date
2020-01-02, 1398/10/12
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
2019-11-22, 1398/09/01
Expected recruitment end date
2020-05-21, 1399/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of hemodynamic changes after caudal anesthesia with intravenous dexamethasone.
Public title
The effect of intravenous dexamethasone injection on hemodynamic changes after caudal anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Parent consent to participate in the study
Age between 1to8 years old
Candidate for elective lower abdominal surgery
Candidate for elective lower limb surgery
Exclusion criteria:
Allergies to anesthesia drugs
Allergies to dexamethason
Coagulation abnormalities
Previous neurological disease
Vertebral anomalies
Any infection at the injection site
Age
From 1 year old to 8 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients to intervention and control groups will be performed using the random numbered table technique via Randlist online software, individually for patients.
In this study, patients were randomly divided into two groups via simple randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
The anesthesiologist who has responsible for the patients management of anesthesia will administer the medicine(s) via coded syringes had been prepared previously and will not aware of the injected drug(dexamethasone or ketamin), and anesthesia nurse who is responsible for collection of patients information and study variables and is unaware of the administered drug will record the check- list during surgery and in the recovery.Also the patient is unaware of the injected medicine.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Faculity of Medicine, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2019-11-26, 1398/09/05
Ethics committee reference number
IR.TBZMED.REC.1398.866
Health conditions studied
1
Description of health condition studied
Hemodynamic changes after caudal anesthesia
ICD-10 code
T88.59
ICD-10 code description
Other complications of anesthesia
Primary outcomes
1
Description
Systolic and diastolic blood pressure
Timepoint
From the beginning of anesthesia to 30th minute,every 5 minutes and after that every 15minutes
Method of measurement
Mercury barometer
Secondary outcomes
1
Description
Mean arterial pressure(MAP)
Timepoint
From the beginning of anesthesia to 30th minute,every 5 minutes and after that every 15minutes
Method of measurement
Mercury barometer
2
Description
Heart rate
Timepoint
From the beginning of anesthesia to 30th minute,every 5 minutes and after that every 15minutes
Method of measurement
Counting in each minutes
3
Description
Partial pressure of end tidal of carbondioxide
Timepoint
From the beginning of anesthesia and then every 30 minutes
Method of measurement
Using the Copnograph
4
Description
Saturation of peripheral oxygen
Timepoint
From the beginning of anesthesia and then every 30 minutes
Method of measurement
Via the Pulse Oximeter
Intervention groups
1
Description
Intervention group:these patients will receive 0.5 mg intravenous dexamethasone while inducing anesthesia with 0.2% bupivacaine at a dose of 1 ml / kg
Category
Treatment - Drugs
2
Description
Control group:these patients will receive 0.5 mg of distilled water (exactly similar to dexamethasone) while inducing anesthesia with bupivacaine 0.2% at a dose of 1 ml / kg.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
operating room, Tabriz Children Hospital
Full name of responsible person
Dr. Mahin Seyedhejazi
Street address
Sheshgelan St , Tabriz Children Hospital,Tabriz city
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2255
Fax
+98 41 3526 2279
Email
kodakanhospital@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Abolghasem Joyban
Street address
Vice chancellor for research, ِDaneshgah street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3335 7310
Fax
+98 41 3335 7310
Email
research-vice@tbzmed.ac.ir
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
Dr. Mahin Seyedhejazi
Position
Associate Professor Of Anesthesia
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Sheshgelan St ,Tabriz Children Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2255
Fax
+98 41 3526 2255
Email
seidhejazie@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mahin Seyedhejazi
Position
Associate Professor Of Anesthesia
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Sheshgelan St ,Tabriz Children Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2255
Fax
+98 41 3526 2255
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
Dr. Mahin Seyedhejazi
Position
Associate Professor Of Anesthesia
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Children Hospital ,Sheshgelan St ,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2255
Fax
+98 41 3526 2255
Email
seidhejazie@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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 collected deidentified IPD, IPD collected for the primary outcome measure are to be shared
When the data will become available and for how long
Starting 6 months after publication .
To whom data/document is available
Documents will be available for people working in academic institutions and also people working in businesses.
Under which criteria data/document could be used
There will be no specific limitations to the utilization of the data
From where data/document is obtainable
Dr .Mahin Seyedhejazi, Department of Anesthesiology, Faculty of Medicine, Golgasht Street, Tabriz East Azarbaijan Islamic Republic of Iran ,Phone+98 413 3341994, Fax+98 41 33341994 , seidhejazie@tbzmed.ac.ir
What processes are involved for a request to access data/document