Childhood Anesthesia and Cognitive Function (UCSF-Anes-01)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to determine whether pediatric anesthesia is associated with long-term hippocampal dysfunction
| Condition |
|---|
|
Cognitive Deficits Cognitive Ability, General |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Is Pediatric Anesthesia Associated With Long-term Hippocampal Dysfunction? |
- Recollection [ Time Frame: 6-12 years of age ] [ Designated as safety issue: Yes ]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
- Familiarity, Child behavioral checklist [ Time Frame: 6-12 years of age ] [ Designated as safety issue: Yes ]cognitive testing
| Estimated Enrollment: | 58 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Treatment
Children who received an anesthetic prior to age 2
|
|
Control
Children who have never been anesthetized
|
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.
Eligibility| Ages Eligible for Study: | 6 Years to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Children who received an anesthetic early in life
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
Contacts and Locations| Contact: Greg Stratmann, MD, PhD | 415-476-1653 | stratman@anesthesia.ucsf.edu |
| Contact: Jeffrey W. Sall, MD, PhD | 415-476-0322 | sallj@anesthetsia.ucsf.edu |
| United States, California | |
| University of Califoria, Davis | Recruiting |
| Davis, California, United States | |
| Contact: Simona Ghetti, PhD 530-747-3803 Simona Ghetti <sghetti@ucdavis.edu> | |
| Principal Investigator: Simona Ghetti, PhD | |
| Univeristy of California, San Francisco | Recruiting |
| San Francisco, California, United States | |
| Contact: Greg Stratmann, MD, PhD 415-476-1653 stratman@anesthesia.ucsf.edu | |
| Contact: Jeffrey W. Sall, MD, PhD 415-476-0322 sallj@anesthesia.ucsf.edu | |
| Principal Investigator: Jeffrey W. Sall, MD/PhD | |
| Principal Investigator: | Greg Stratmann, MD, PhD | University of California, San Francisco |
More Information
No publications provided
| Responsible Party: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT01359215 History of Changes |
| Other Study ID Numbers: | 10-01926 |
| Study First Received: | May 20, 2011 |
| Last Updated: | June 11, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Anesthetics Central Nervous System Depressants Physiological Effects of Drugs |
Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013