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

Is Pediatric Anesthesia Associated With Long-term Hippocampal Dysfunction?

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

Study Overview

• Status: Completed
• Conditions: Cognitive Ability, General; Cognitive Deficits

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
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United States
  • California
    • Davis, California, United States
      • University of Califoria, Davis
    • San Francisco, California, United States
      • Univeristy of California, San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children who received an anesthetic early in life

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Treatment; Children who received an anesthetic prior to age 2
Control; Children who have never been anesthetized

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recollection	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	6-12 years of age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Familiarity, Child behavioral checklist	cognitive testing	6-12 years of age

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: University of California, Davis
• Investigators: Principal Investigator: Greg Stratmann, MD, PhD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: May 20, 2011
• First Submitted That Met QC Criteria: May 23, 2011
• First Posted (Estimate): May 24, 2011

Study Record Updates

• Last Update Posted (Estimate): December 12, 2013
• Last Update Submitted That Met QC Criteria: December 11, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognitive Dysfunction; Cognition Disorders
• Other Study ID Numbers: 10-01926