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Completed

NCT Number: NCT01359215

Childhood Anesthesia and Cognitive Function

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

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Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Califoria, Davis, Davis, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Recollection

    Time frame: 6-12 years of age

    Subjects who received and anesthetic during the first two years of life and controls are given a cognitive test at 6 to 12 years of age

Secondary outcomes

  1. Familiarity, Child behavioral checklist

    Time frame: 6-12 years of age

    cognitive testing

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • University of California, Davis

Registry information

Official study title

Is Pediatric Anesthesia Associated With Long-term Hippocampal Dysfunction?

Acronym: UCSF-Anes-01

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 24, 2011
Registry last updated
Dec 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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