Comparison the effects of remifentanyl combined with atropine with fentanyl and remifentanyl alone on vital signs in non-emergent intra-tracheal intubation in preterm neonates
The goal of this study is comparison the effects of fentanyl, remifentanyl and atropine combined with remifentanyl on vital signs in non-emergent intra-tracheal intubation in preterm neonates.
Design
In this study 75 cases will be divided into 3 groups:
1) Fentanyl 2 µg/kg and then intubation
2) Remifentanyl 1µg/kg and then intubation
3) Atropin 20 µg/kg plus Remifentanyl 1µg/kg and then intubation.
Simple randomization using RandList software (v:1.2) and double blind study will be used
Physician in attendance and nurse will be blind in this study
Settings and conduct
The study will be conducted in the Pediatrics and Alzahra hospital neonatal intensive care units.Based on the inclusion criteria, infants will be divided into three groups, and in each group, the effectiveness of existing analgesics will be examined, so that the therapist and information analyzer will not be aware of the used drugs and will recognize them based on the code.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1) Preterm neonates (27-34 week-old) in need of intubation and surfactant administration
2) Without any major anomalies
3) Parents agree to participate in research
4) Respiratory Score of neonates under 8 based on acute critical care of neonates
Exclusion criteria:
1) No need for intubation
2) Major anomalies
3) Neonates with family history of Myasthenia gravis
Intervention groups
27-34 weeks neonates in need of temporary intubation in three groups receive the following treatments:
1) Fentanyl 2 µg/kg and then intubation
2) Remifentanyl 1µg/kg and then intubation
3) Atropin 20 µg/kg plus Remifentanyl 1µg/kg and then intubation
Comparison the effects of remifentanyl combined with atropine with fentanyl and remifentanyl alone on vital signs in non-emergent intra-tracheal intubation in preterm neonates
Public title
Comparison the effects of analgesic drugs on vital signs in intra-tracheal intubation in preterm neonates
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Preterm neonates (27-34 week-old) in need of Surfactant administration
Without any major anomalies
Parents agree to participate in research
Respiratory Score of neonates under 8 based on Critical care of the neonate
Exclusion criteria:
No need for intubation
Neonates with family history of Myasthenia gravis
Major anomalies
Age
From 1 day old to 3 days old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Data analyser
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization using random numbers
75 samples will be divided into 3 groups using RandList software (v:1.2)
physician in attendance and nurse will be blind in this study.
Blinding (investigator's opinion)
Double blinded
Blinding description
Drugs used in this study will be prepared in same shape and color syringes by someone who will not be aware of the process of study. Syringes will be given under the title A, B and C, to clinical caregiver and researcher. Clinical data analyzer will not have any information about the type of drug in the syringes. The content on each syringes will be declared for data monitoring team after completing the data analysis .
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research ethics committee of Tabriz University of Medical Sciences
Street address
International Relations Office, No 2 Central Building, Tabriz University of Medical Sciences, University Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Approval date
2019-10-28, 1398/08/06
Ethics committee reference number
IR.TBZMED.REC.1398.793
Health conditions studied
1
Description of health condition studied
Neonates with respiratory distress
ICD-10 code
P22
ICD-10 code description
Respiratory distress of newborn
Primary outcomes
1
Description
Systemic blood pressure
Timepoint
1-3 days old
Method of measurement
Monitoring device
2
Description
Heart rate
Timepoint
1-3 days old
Method of measurement
Monitoring device
3
Description
hypoxia severity
Timepoint
1-3 days old
Method of measurement
Pulsoxymeter
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 1) Fentanyl 2 µg/kg and then intubation
Category
Treatment - Drugs
2
Description
Intervention group:2) Remifentanyl 1µg/kg and then intubation
Category
Treatment - Drugs
3
Description
Intervention group: 3) Atropin 20 µg/kg plus Remifentanyl 2µg/kg intravenous and then intubation
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Children's Hospital and Tabriz AL-Zahra Hospital
Full name of responsible person
MirHadi Mousavi
Street address
Sheshgelan st.Children's Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2255
Email
mirhadimousavi33@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Sameay
Street address
Golgasht St.Deputy Research and Technology
City
Tabriz
Province
East Azarbaijan
Postal code
5165995131
Phone
+98 41 3335 7310
Email
research-vice@tbzmed.ac.ir
Web page address
https://researchvice.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
MirHadi mousavi
Position
Assistant Prof.
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Sheshgelan St.Childreen Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2255
Email
mirhadimousavi33@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
MirHadi Mousavi
Position
Assistant Prof.
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Seshgelan St, Children Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2255
Email
mirhadimousavi33@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mihadi mousavi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Sheshglan St, Children Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 35262279
Email
mirhadimousavi33@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 whole data can be shared after unidentifiable people
When the data will become available and for how long
Start the access period 3 months after printing results
To whom data/document is available
Data will only be available to researchers working in academic and academic institutions
Under which criteria data/document could be used
Using the findings will not be a problem with the source
From where data/document is obtainable
By sending a request to the email: mirhadimousavi33@yahoo.com
What processes are involved for a request to access data/document
- Sending a request to the email with the applicant's scientific and academic documentation
- Submit the requested documentation within a week to the applicant