Childhood Anesthesia and Cognitive Function

Cognitive Ability, General Clinical Trial

— UCSF-Anes-01  

Official title:

Is Pediatric Anesthesia Associated With Long-term Hippocampal Dysfunction?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01359215
• Other study ID #: 10-01926
• Status: Completed
• Phase: N/A
• First received: May 20, 2011
• Last updated: December 11, 2013
• Start date: March 2011
• Est. completion date: May 2012

Study information

• Verified date: December 2013
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Ability, General
• Cognitive Deficits

Locations

Country	Name	City	State
United States	University of Califoria, Davis	Davis	California
United States	Univeristy of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Familiarity, Child behavioral checklist	cognitive testing	6-12 years of age	Yes