Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01359215
Other study ID # 10-01926
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT00747396 - The Bucharest Early Intervention Project N/A
Completed NCT01407770 - Genetic Susceptibility to Radiation-Induced Skin Reactions in Racial/Ethnic Groups of Patients With Breast Cancer
Completed NCT02394899 - Improving Parental Psychosocial Functioning and Early Developmental Outcomes in Children With Sickle Cell Disease N/A
Completed NCT02274883 - The Effect of Feeding Infant Formula With Enriched Protein Fractions N/A
Enrolling by invitation NCT02066571 - Study to Assess the Clinical Benefit and Safety of Droxidopa in Parkinson's Disease Phase 2
Completed NCT02780739 - INSIGHT, A Comprehensive, Multidisciplinary Brain Training System N/A
Completed NCT02461693 - Evaluating the Role of Expectations in Response to Caffeine Consumption: An RCT N/A
Completed NCT01868165 - Assessing the Impact of Calcium Channel Blockers on COGnitive Function in the Very Elderly (AI-COG)
Completed NCT02630667 - The Acute Effects Fortified Nutritional Supplementation on Childhood Cognition N/A
Completed NCT01375348 - Relationship Between Cognitive Function and Pain Phase 3
Completed NCT02853279 - Physical Activity and Intermittent Exercise Training for Cardiovascular and Cognitive Gain in Obese Women N/A
Completed NCT00894205 - Neuropsychological Effects of Strengthening Exercise for Older Adults Phase 2
Completed NCT04442477 - Neurodevelopment at 5.5 Years of Age in Children Who Received Infant Formula With Enriched Protein Fractions
Completed NCT01167400 - Cybercycling for Cognitive Health N/A
Completed NCT03137836 - Classroom Standing Desks for Reducing Sitting Time in Children N/A
Completed NCT02136368 - Body and Brain Exercise for Older Adults With Memory Complaints N/A
Completed NCT00841321 - Trial of Ginkgo as a Treatment for Cognitive Problems in Multiple Sclerosis Phase 2
Active, not recruiting NCT01504633 - Nutrigenomics, PUFA, Iron and Cognition Amongst Under-two-year-old Indonesian Children N/A
Completed NCT02726906 - Lifestyle Enriching Activities for Research in Neuroscience Intervention Trial: LEARNit Study N/A
Not yet recruiting NCT02123355 - The Effect of Dexmedetomidine to Cognition of Geriatrics in Prolonged Surgery Phase 4