CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 153 enrolled
Drug / intervention
Isoflurane +2 moredrug
Likely dose
Fentanyl (high dose) 5 mcg/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/NCT03882788
NCT03882788N/ACompleted
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Anesthesia and the Developing Brain: a Comparison of Two Anesthetic Techniques

Stanford University·interventional·Posted Mar 20, 2019·Updated May 9, 2022

In Brief

A clinical study evaluating Isoflurane, Fentanyl (high dose), and 1 other intervention for Anesthesia; Adverse Effect and 2 related conditions. Completed, enrolled 153 participants across 1 site.

Detailed Summary

The purpose of this study is to assess whether the type of anesthesia, narcotic-based versus inhalational anesthesia administered during cardiopulmonary bypass (CPB) surgery contributes to the wide variation in neurologic recovery and developmental outcome after surgery in infants with congenital heart disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnesthesia; Adverse Effect, Congenital Heart Disease, Neurodevelopmental Disorders
CountriesUnited States
CollaboratorsThe Gerber Foundation

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 20, 2019
Enrollment StartApr 22, 2013
Primary CompletionNov 19, 2020
TodayJul 2, 2026
Enrollment to primary: 7.6 yearsPosted 7.3 years ago

Interventions

Isofluranedrug

Isoflurane (volatile anesthesia) will be delivered at 1.5-2.0%% as required for anesthetic management.

Fentanyl (high dose)drug

Fentanyl (narcotic anesthesia) maintenance will be with fentanyl 5 mcg/kg/hr not to exceed 10 mcg/kg/hr.

Fentanyl (low dose)drug

Fentanyl (narcotic anesthesia) maintenance will be with fentanyl 2 mcg/kg/hr.