CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
Propofol Group 1 +3 moredrug
Likely dose
Propofol Group 1 2.0 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04904965
NCT04904965N/ACompleted

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

Pontificia Universidad Catolica de Chile·interventional·Posted May 27, 2021·Updated Mar 7, 2023

In Brief

A clinical study evaluating Propofol Group 1, Propofol Group 2, and 2 other interventions for Anesthesia and 3 related conditions. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChile
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedMay 27, 2021
Enrollment StartMay 3, 2021
Primary CompletionDec 3, 2022
Study CompletionMar 3, 2023
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 5.1 years ago

Interventions

Propofol Group 1drug

Propofol 2.0 mg/kg/hr per 10 min

Propofol Group 2drug

Propofol 4.0 mg/kg/hr per 10 min

Propofol Group 3drug

Propofol 6.0 mg/kg/hr per 10 min

Propofol Group 4drug

Propofol 8.0 mg/kg/hr per 10 min