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IRCT20160102025811N3 IRCT 2020-02-04 Tabriz University of Medical Sciences Comparison the effects of analgesic drugs on vital signs in intra-tracheal intubation in preterm neonates INSUR - ACORN 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 2020-01-21 anticipated 75 Complete https://irct.ir/trial/37856 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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 . 2-3 Neonates with respiratory distress. Intervention 1: Intervention group: 1) Fentanyl 2 µg/kg and then intubation. Intervention 2: Intervention group:2) Remifentanyl 1µg/kg and then intubation. Intervention 3: Intervention group: 3) Atropin 20 µg/kg plus Remifentanyl 2µg/kg intravenous and then intubation. Yes - There is a plan to make this available What will be shared: The whole data can be shared after unidentifiable people When: Start the access period 3 months after printing results To whom: Data will only be available to researchers working in academic and academic institutions Conditions: Using the findings will not be a problem with the source Where to obtain: By sending a request to the email: mirhadimousavi33@yahoo.com How to obtain: - Sending a request to the email with the applicant's scientific and academic documentation - Submit the requested documentation within a week to the applicant Comments:
public MirHadi mousavi
Sheshgelan St.Childreen Hospital
Tabriz Iran (Islamic Republic of) 5136735886 +98 41 3526 2255 mirhadimousavi33@yahoo.com Tabriz University of Medical Sciences scientific MirHadi Mousavi
Seshgelan St, Children Hospital
Tabriz Iran (Islamic Republic of) 5136735886 +98 41 3526 2255 mirhadimousavi33@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) 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 1 day 3 days Both No need for intubation Neonates with family history of Myasthenia gravis Major anomalies P22 Respiratory distress of newborn Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: 1) Fentanyl 2 µg/kg and then intubation Intervention group:2) Remifentanyl 1µg/kg and then intubation Intervention group: 3) Atropin 20 µg/kg plus Remifentanyl 2µg/kg intravenous and then intubation Systemic blood pressure. Timepoint: 1-3 days old. Method of measurement: Monitoring device. Heart rate. Timepoint: 1-3 days old. Method of measurement: Monitoring device. Hypoxia severity. Timepoint: 1-3 days old. Method of measurement: Pulsoxymeter. Tabriz University of Medical Sciences Approved 2019-10-28 Research ethics committee of Tabriz University of Medical Sciences International Relations Office, No 2 Central Building, Tabriz University of Medical Sciences, University Street, Tabriz, Iran Tabriz East Azarbaijan Iran (Islamic Republic of)