drugset / Trial / NCT04904965

Frontal Electroencephalography of Neonatal Patients Under Sedation With Opioids and General Anesthesia With Propofol.

NCT04904965 ↗

RandomizedFactorialTriple-blindDiagnostic

Summary

Frequently, neonates hospitalized in neonatology units require anesthesia for surgery. The drugs used for this purpose are opioids and other anesthetics, such as propofol. Currently, the administration of anesthesia is difficult in neonates due to the neurological immaturity of these patients, the scarcity of adequate pharmacological studies, the prolonged use of one or more sedatives prior to surgery and the limited usefulness of current anesthetic monitoring devices in this population. Electroencephalography (EEG), which has allowed estimation of anesthetic depth in other populations, has been less explored in neonates. To date, there are no EEG markers, correlated with a given dose of anesthesia, that allow an adequate administration in this kind of patients. In this context, a better understanding of the anesthetic effect in the neonatal brain would allow defining characteristic EEG patterns, improving the estimation of anesthetic depth and anesthetic dosage in neonates.

Timeline

Start
2021-05-03
Primary completion
2022-12-03
Completion
2023-03-03

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Propofol Small molecule 2 mg/kg Intravenous
Subject Propofol Small molecule 4 mg/kg Intravenous
Subject Propofol Small molecule 6 mg/kg Intravenous
Subject Propofol Small molecule 8 mg/kg Intravenous

Indications

No indication recorded.