Dexmedetomidine sedation in awake caudal block for lower abdominal surgeries in neonates
Design
Clinical trial with intervention groups, with parallel groups, double-blinded, randomized
Settings and conduct
In this double-blind randomized clinical trial, 100 patients Weighing less than 4 Kg from Tabriz children hospital with American society of Anesthesiologists (ASA) status I and II, undergoing lower abdominal surgeries will be enrolled The patients will be randomized in one of the two groups of Sedation with Dexmedetomidine (D) and sedation with Normal saline(N)
Participants/Inclusion and exclusion criteria
Inclusion criteria:Neonates Weighing less than 4 Kg Surgery of the lower abdomen ASA Class I and II Exclusion criteria: Patients with congenital neurological disease and seizures Caudal injection site infection Sepsis Sensitivity to topical anesthetics Bradycardia(HR<120) Any kind of heart block Congenital cyanotic heart diseases
Intervention groups
neonates first intervention group with ASA class I and II after proper monitoring including ECG and SPO2 NIBP in D group neonates Receive Dexmedetomidine 1ml/kg and N group infant receive normal saline 1ml/kg. after administration of the drug the patients viatal signs are recorded and repeated every 1 minute and 3 minute after administration of the drug neonates in the lateral position with a 22G needle and bolupasaine 0/2%(1MG/KG) plus epinephrine 1-2 mg experiences are under the caudal block
Main outcome variables
Blood pressure،Heart rate،SPO2، duration of stay in recovery،Apene،number of times to do caudal bloack،duration of performance caudal block، Sedation Score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190114042358N3
Registration date:2020-04-23, 1399/02/04
Registration timing:retrospective
Last update:2020-04-23, 1399/02/04
Update count:0
Registration date
2020-04-23, 1399/02/04
Registrant information
Name
Daryoush Sheikhzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3526 2257
Email address
dr.d.sheik@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2020-01-21, 1398/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Dexmedetomidine sedation in awake caudal block for lower abdominal surgeries in neonates
Public title
Dexmedetomidine sedation in awake caudal block for lower abdominal surgeries in neonates
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infant Weighing less than 4 Kg
Surgery of the lower abdomen
ASA Class 1 and2
Exclusion criteria:
Patients with congenital neurological disease and seizures
Caudal injection site infection
Sepsis
Sensitivity to topical anesthetics
Bradycardia(HR<120)
Any kind of heart block
Congenital cyanotic heart diseases
Age
From 1 day old to 30 days old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Random method: Block, Random unit: individual, Random Tool: Random Block 4. for this purpose, 25 blocks with 4 subjects in each block will be used. the combination of all patterns will be considered including AABB, ABAB, BABA, BBAA, BABA, BAAB. For selecting each blocks, dice drooped and the block number will be selected. this procedure continued to completed the allocation and reached to sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double-blinded study and Researcher and patients are kept unaware of intervention in each group and In order to allocation concealment, the type of intervention will be written on paper and placed in numbered, matte and packed envelopes.The envelopes will be opened in the order of participation of the participants and the type of group will be determined
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Science,Gholghasht,Azadi Street,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Approval date
2020-01-06, 1398/10/16
Ethics committee reference number
IR.TBZMED.REC.1398.10.92
Health conditions studied
1
Description of health condition studied
caudal block(Local anaesthetics)
ICD-10 code
Y48.3
ICD-10 code description
Anaesthetics and therapeutic gases
Primary outcomes
1
Description
Blood pressure
Timepoint
After entering the operating room،After doing caudal block every 1 minute to 5 minutes and every 5 minutes till release from recovery
Method of measurement
Monitor
2
Description
Heart rate
Timepoint
After entering the operating room،After doing caudal block every 1 minute to 5 minutes and every 5 minutes till release from recovery
Method of measurement
ECG device
3
Description
SPO2
Timepoint
After entering the operating room،After doing caudal block every 1 minute to 5 minutes and every 5 minutes till release from recovery
Method of measurement
pulse oximeter device
4
Description
Duration of the block
Timepoint
after proper monitoring in D group of neonates recieve 1ml/kg Dexmedetomidine and in N group of neonates recieve normal saline(1ml/kg) after administrating the druge the time required to perform the caudal block is recorded
Method of measurement
by an experienced anesthesiologist
5
Description
the number of attempts for block
Timepoint
after proper monitoring in D group of neonates recieve 1ml/kg Dexmedetomidine and in N group of neonates recieve1ml/kg normal saline after administrating the druge the number of times you try to perform caudal block is recorded
Method of measurement
by an experienced anesthesiologist
6
Description
Duration of stay in recovery
Timepoint
After entering till release from recovery
Method of measurement
According to Alderet Score
7
Description
Apnea
Timepoint
After entering till release from recovery
Method of measurement
monitor and face and color scale
8
Description
Sedation
Timepoint
15 minutes after the block، and then every 5 minutes till release from recovery
Method of measurement
Sedation score table
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: neonates first intervention group with ASA class I and II after proper monitoring including ECG and SPO2 NIBP in D group neonates Receive Dexmedetomidine 1ml/kg after administration of the drug the patients viatal signs are recorded and repeated every 1 minute and 3 minute after administration of the drug neonates in the lateral position with a 22G needle and bolupasaine 0/2%(1MG/KG) plus epinephrine 1-2 mg experiences are under the caudal block
Category
Treatment - Drugs
2
Description
Intervention group: neonates first intervention group with ASA class I and II after proper monitoring including ECG and SPO2 NIBP in N group infant receive normal saline 1ml/kg. after administration of the drug the patients viatal signs are recorded and repeated every 1 minute and 3 minute after administration of the drug neonates in the lateral position with a 22G needle and bolupasaine 0/2%(1MG/KG) plus epinephrine 1-2 mg experiences are under the caudal block
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Childrens Hospital
Full name of responsible person
Daryoush Sheikhzadeh
Street address
Tabriz Childrens Hospital,Sheshgelan St
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2255
Email
dr.d.sheik@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jouyban
Street address
Tabriz University of Medical Sciences,Golghasht St
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3335 7310
Email
ajouyban@hotmail.com
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
Daryoush Sheikhzadeh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Tabriz Childrens Hospital,Sheshgelan St
City
Tabriz
Province
East Azarbaijan
Postal code
5136735883
Phone
+98 41 3526 2255
Email
dr.d.sheik@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Daryoush Sheikhzadeh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Tabriz Childrens Hospital,Sheshgelan St
City
Tabriz
Province
East Azarbaijan
Postal code
5136735883
Phone
+98 41 3526 2255
Email
dr.d.sheik@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Daryoush Sheikhzadeh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Tabriz Childrens Hospital,Sheshgelan St
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2255
Email
dr.d.sheik@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
A portion of the data that represents the final outcome
When the data will become available and for how long
Access will be 6 months after the results are printed.
To whom data/document is available
All Physicians and residents of the department of Anesthesia
Under which criteria data/document could be used
After obtaining permission from the deputy research of group
From where data/document is obtainable
Person responsible for scientific accountability of study
What processes are involved for a request to access data/document