drugset / Trial / NCT02700893

Cerebral NIRS Profiles During Premedication for Neonatal Intubation

NCT02700893

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Observational ancillary study of the PRETTINEO study (ClinicalTrials.gov Identifier: NCT01490580) which is a multicenter double blind randomized controlled trial comparing "atropine+propofol" vs "atropine+atracurium+sufentanil" as a premedication prior to endotracheal intubation of the neonate. Primary outcome: * Cerebral desaturation defined by a rScO2 delta \>20% from the baseline value (before premedication). * Variation of more than 10% of cerebral FTOE (Fractional Tissue Oxygen Extraction) during premedication, calculated from rScO2 and pulse oximetry with the formula FTOE=SaO2 - rScO2/SaO2 . Hypothesis: "atropine + propofol" compared to "atropine+atracurium+sufentanil" does not increase the frequency of cerebral hypoxemia.

Timeline

Start
2016-03
Primary completion
2016-08
Completion
2016-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Atracurium Small molecule 0.3 mg/kg
Subject Propofol Small molecule 1 mg/kg
Subject Propofol Small molecule 2.5 mg/kg
Comparator Sufentanil Other / unclassified 0.1 ug/kg
Comparator Sufentanil Other / unclassified 0.2 ug/kg
Comparator Atropine Other / unclassified 20 ug/kg