Childhood Anesthesia and Cognitive Function

NCT01359215 | Completed

• 1 other identifier: 10-01926
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Cognitive Deficits; Cognitive Ability, General

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Familiarity, Child behavioral checklist

  6-12 years of age

Study Arms (2)

Treatment

Children who received an anesthetic prior to age 2

Control

Children who have never been anesthetized

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children who received an anesthetic early in life

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, San Francisco: lead
• University of California, Davis: collaborator

Study Sites (2)

University of Califoria, Davis

Davis, California, United States

Location

Univeristy of California, San Francisco

San Francisco, California, United States

Location

MeSH Terms

Conditions

Cognition Disorders

Condition Hierarchy (Ancestors)

Neurocognitive Disorders; Mental Disorders

Study Officials

• Greg Stratmann, MD, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2011
• First Posted: May 24, 2011
• Study Start: March 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: December 12, 2013

Record last verified: 2013-12

Locations

US (2)