Childhood Anesthesia and Cognitive Function

Completed

• Conditions: Cognitive Deficits; Cognitive Ability, General

• Registration Number: NCT01359215
• Lead Sponsor: 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

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 Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-05-20
• Study First Submitted QC: 2011-05-23
• Study First Posted: 2011-05-24
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-11
• Last Update Posted: 2013-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recollection	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

Name	Time	Method
Familiarity, Child behavioral checklist	6-12 years of age	cognitive testing

Trial Locations

Locations (2)

University of Califoria, Davis; 🇺🇸 Davis, California, United States

Univeristy of California, San Francisco; 🇺🇸 San Francisco, California, United States