Childhood Anesthesia and Cognitive Function

NCT ID: NCT01359215

Last Updated: 2013-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-05-31

Brief Summary

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The purpose of this study is to determine whether pediatric anesthesia is associated with long-term hippocampal dysfunction

Detailed Description

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Contrary to a longstanding belief, anesthesia has lasting effects on the neonatal brain. In rats anesthesia causes death of brain cells, ill-timed conversion of stem cells to nerve cells and a certain kind of brain defect up to 8 months later. This brain defect is called a hippocampal deficit because it resembles the type of defect that people have when a structure in the brain called the hippocampus has been injured, removed or is no longer functioning. However, to date it is unknown if anesthesia given to human infants causes a lasting hippocampal deficit, which might manifest itself as memory problems and academic failure despite normal intelligence. The investigators will test the hypothesis that anesthesia for more than 2h given to children of less than 2 years of age without coexisting diseases of the brain or the heart causes long-term impairment of hippocampal function. Using state of the art hippocampal and general brain function testing the investigators will compare hippocampal dependent and hippocampal independent memory as well as general cognitive function and emotional state in 10 year-old children that underwent at least a 2h anesthetic at less than 2 years with that of a matched control group that did not undergo an anesthetic.

Conditions

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Cognitive Deficits Cognitive Ability, General

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Treatment

Children who received an anesthetic prior to age 2

No interventions assigned to this group

Control

Children who have never been anesthetized

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Anesthesia at less than 2 years of age
* Anesthetic time greater than 2 hours
* ASA I or II
* Induction with Propofol or Sevoflurane +/- N2O
* Maintenance with a volatile agent (sevoflurane, isoflurane, desflurane) +/- N2O

Exclusion Criteria

* Neurosurgery
* Known genetic syndrome
* Any other anesthetic agents (ketamine, meperidine, barbiturates, etomidate, methoxyflurane, methadone, lorazepam)
* Low birthweight (\<25%ile)
* Gestational age , 36 weeks
* color blindness
* h/o CNS disease
* cancer
* head trauma
* congenital heart disease
* ASA III or IV
* intra-operative hypotension (\<30% baseline for \> 5 min)
* Bradycardia (\<30% baseline for \> 5 min)
* Hypoxemia (Blood Oxygen Saturation \<93% for \> 5 min)
* Hypercarbia (pCO2 \> 60 mm Hg \> 5 min)
* Dysthermia (deviation from 36.5 deg C by \> 1.5 deg C at any time)
* Puberty
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, Davis

OTHER

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Greg Stratmann, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of Califoria, Davis

Davis, California, United States

Site Status

Univeristy of California, San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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10-01926

Identifier Type: -

Identifier Source: org_study_id