Childhood Anesthesia and Cognitive Function (UCSF-Anes-01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01359215
Recruitment Status : Completed
First Posted : May 24, 2011
Last Update Posted : December 12, 2013
University of California, Davis
Information provided by (Responsible Party):
University of California, San Francisco

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

Condition or disease
Cognitive Deficits Cognitive Ability, General

Detailed Description:
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.

Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Is Pediatric Anesthesia Associated With Long-term Hippocampal Dysfunction?
Study Start Date : March 2011
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

Children who received an anesthetic prior to age 2
Children who have never been anesthetized

Primary Outcome Measures :
  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 Outcome Measures :
  1. Familiarity, Child behavioral checklist [ Time Frame: 6-12 years of age ]
    cognitive testing

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Children who received an anesthetic early in life

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01359215

United States, California
University of Califoria, Davis
Davis, California, United States
Univeristy of California, San Francisco
San Francisco, California, United States
Sponsors and Collaborators
University of California, San Francisco
University of California, Davis
Principal Investigator: Greg Stratmann, MD, PhD University of California, San Francisco

Responsible Party: University of California, San Francisco Identifier: NCT01359215     History of Changes
Other Study ID Numbers: 10-01926
First Posted: May 24, 2011    Key Record Dates
Last Update Posted: December 12, 2013
Last Verified: December 2013

Additional relevant MeSH terms:
Cognition Disorders
Cognitive Dysfunction
Neurocognitive Disorders
Mental Disorders