The Effect of Anesthesia on Neurodevelopmental Outcome (NDO)

NCT03882788 | Completed Results DMC

• 1 other identifier: NDO
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Bayley III

  Neurodevelopmental assessment scores are age dependent and based motor and behavioral abilities, often reported for normal or abnormal for age. Bayley Scales of Infant and Toddler Development, third edition, (Bayley III) is an instrument designed to measure the developmental functioning of infants and toddlers between the ages of 1 month and 42 months (age adjustments for prematurity are accommodated with the tool). It provides age specific composite scores for cognitive (91 items, score min 55 max 145), language (98 items, score min 47 max 153), and motor (138 items, score min 46 max 154) skills. For all scales, higher scores are better and lower scores indicate possible delay/deficit.

  Assessed once between age 18 to 48 months (approximately 2 hours to assess), up to 48 months from study start

• Electroencephalogram

  Brain electrical activity: observation is for brain region specific abnormal or seizure activity. Number of participants with abnormal EEG are reported.

  EEG taken immediately prior to surgery, during surgery, during cardiovascular intensive care unit (CVICU) stay (up to 48 hours after surgery), and immediately prior to discharge (between 5 to 20 minutes to assess EEG at each time point)

Secondary Outcomes (4)

• Choline

  0-72 hours

• Glutamate

  0-72 hours

• N-acetylaspartate (Naa)

  0-72 hours

• Lactate

  0-72 hours

Study Arms (2)

Volatile Anesthesia

ACTIVE COMPARATOR

In volatile anesthetic technique, maintenance of anesthesia will be standardized to the anesthesia will be standardized to the volatile anesthetic isoflurane. Rocuronium or pancuronium will be used for muscle relaxation. Additionally, narcotic fentanyl will be administered at no greater than 2 mcg/kg/hr (low dose). However, the primary anesthetic during CPB will be isoflurane with no narcotic administered during CPB.

Drug: Isoflurane; Drug: Fentanyl (low dose)

Narcotic based anesthesia

ACTIVE COMPARATOR

In narcotic based anesthetic technique, no volatile anesthetics will be used past induction. Maintenance of anesthesia will be with fentanyl 5 mcg/kg/hr not to exceed 10 mcg/kg/hr (high dose).

Drug: Fentanyl (high dose)

Interventions

Isoflurane DRUG

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

Volatile Anesthesia

Fentanyl (high dose) DRUG

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

Narcotic based anesthesia

Fentanyl (low dose) DRUG

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

Volatile Anesthesia

Eligibility Criteria

• Age: 1 Day - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Neonates of at least 32 weeks of gestation, infants and children up to 2 years of age admitted to The Children's Hospital for treatment of cyanotic or non-cyanotic heart disease requiring surgical intervention.
• Admitting diagnosis of cyanotic or non-cyanotic heart disease

You may not qualify if:

• Neonates less than 32 weeks of gestational age, and children more than 2 years of age.
• Any documented central nervous system malformations.
• Any potential subject requiring unexpected postoperative Extracorporeal membrane oxygenation (ECMO) support

Sponsors & Collaborators

• Stanford University: lead
• The Gerber Foundation: collaborator

Study Sites (1)

Stanford Childrens hospital

Palo Alto, California, 94305, United States

Location

MeSH Terms

Conditions

Heart Defects, Congenital; Neurodevelopmental Disorders

Interventions

Isoflurane; Fentanyl

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Mental Disorders

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Clinical Trials Manager
• Organization: Research Office

clinicaltrials-gov@stanford.edu

650-724-1720

Study Officials

• Lisa W Faberowski, MD, MSc

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: EEG, metabolic/NMRS analysis and neurodevelopment outcome is blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2016
• First Posted: March 20, 2019
• Study Start: April 22, 2013
• Primary Completion: November 19, 2020
• Study Completion: November 19, 2020
• Last Updated: May 9, 2022
• Results First Posted: May 9, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)