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The Effect of Anesthesia on Neurodevelopmental Outcome (NDO)

NCT03882788 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2022-05-09

Study results available
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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.

Conditions

  • Anesthesia; Adverse Effect
  • Congenital Heart Disease
  • Neurodevelopmental Disorders

Interventions

DRUG

Isoflurane

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

DRUG

Fentanyl (high dose)

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

DRUG

Fentanyl (low dose)

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

Sponsors & Collaborators

Principal Investigators

  • Lisa W Faberowski, MD, MSc · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
36 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-22
Primary Completion
2020-11-19
Completion
2020-11-19

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03882788 on ClinicalTrials.gov