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

This study has been completed.
Sponsor:
Collaborator:
University of California, Davis
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01359215
First received: May 20, 2011
Last updated: December 11, 2013
Last verified: December 2013
  Purpose

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


Condition
Cognitive Deficits
Cognitive Ability, General

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Is Pediatric Anesthesia Associated With Long-term Hippocampal Dysfunction?

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Recollection [ Time Frame: 6-12 years of age ] [ Designated as safety issue: Yes ]
    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:
  • Familiarity, Child behavioral checklist [ Time Frame: 6-12 years of age ] [ Designated as safety issue: Yes ]
    cognitive testing


Enrollment: 30
Study Start Date: March 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Treatment
Children who received an anesthetic prior to age 2
Control
Children who have never been anesthetized

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.

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Children who received an anesthetic early in life

Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01359215

Locations
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
Investigators
Principal Investigator: Greg Stratmann, MD, PhD University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01359215     History of Changes
Other Study ID Numbers: 10-01926
Study First Received: May 20, 2011
Last Updated: December 11, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014