drugset / Trial / NCT02700893
Cerebral NIRS Profiles During Premedication for Neonatal Intubation
Phase 2/3
Completed
28 enrolled
Centre Hospitalier Intercommunal Creteil
Association Clinique Thérapeutique Infantile du val de Marne · collabCentre de Recherche Clinique du CHIC · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — |