Cognitive DeficitsUCSF-Anes-01NCT01359215
Childhood Anesthesia and Cognitive Function
An observational study of Cognitive Deficits and Cognitive Ability, General, run by University of California, San Francisco at 2 sites in United States.
Trial summary
The purpose of this study is to determine whether pediatric anesthesia is associated with long-term hippocampal dysfunction Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Deficits, Cognitive Ability, General
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2011to May 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children who received an anesthetic early in life
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Califoria, Davis
Davis, California
Univeristy of California, San Francisco
San Francisco, California
About this study
Official title: Is Pediatric Anesthesia Associated With Long-term Hippocampal Dysfunction?
The purpose of this study is to determine whether pediatric anesthesia is associated with long-term hippocampal dysfunction
Read the 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.
- Conditions
- Cognitive Deficits, Cognitive Ability, General
- Medical subject headings
- Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Children who received an anesthetic prior to age 2 | |
| Control | Children who have never been anesthetized |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6-12 years of age
Secondary outcomes (1)
Familiarity, Child behavioral checklist
cognitive testing
Measured: 6-12 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2011 (estimated)
- Study startMar 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DeficitsStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Davis
- Responsible party
- Sponsor
- Investigators
- Greg Stratmann, MD, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01359215
- Sponsor's protocol ID
- 10-01926
- Acronym
- UCSF-Anes-01
- Status last verified
- Dec 2013
- First submitted
- 20 May 2011
- Last updated
- 12 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Pediatric Anesthesia Associated With Long-term Hippocampal Dysfunction?
- ClinicalTrials.gov ID
- NCT01359215
- Acronym / sponsor ID
- UCSF-Anes-01 / 10-01926
- Conditions
- Cognitive Deficits, Cognitive Ability, General
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- University of California, Davis
- Study start
- Mar 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 24 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | – | –Children who received an anesthetic prior to age 2 |
| Control | – | –Children who have never been anesthetized |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children who received an anesthetic early in life
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- Neurosurgery
- Known genetic syndrome
- Any other anesthetic agents (ketamine, meperidine, barbiturates, etomidate, methoxyflurane, methadone, lorazepam)
- Low birthweight (<25%ile)
- Gestational age , 36 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Recollection
Time frame: 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
1 secondary outcome
Familiarity, Child behavioral checklist
Time frame: 6-12 years of age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2013.
Related trials for Cognitive Deficits
Enrolling by invitationPhase 4
Effects of Ciprofol on Perioperative Neurocognitive Function in Elderly Patients Undergoing Daytime Surgery
PND, POCD - Postoperative Cognitive Dysfunction
RecruitingObservational study
Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy
Irritability, Disruptive Mood Dysregulation Disorder
Recruiting
The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults Study
Obstructive Sleep Apnea, Cognitive Decline
RecruitingObservational study
Development and Validation of Risk Prediction Models for Stroke and Cognitive Impairment in Moyamoya Disease and Moyamoya Syndrome
Moyamoya Disease, Moyamoya Syndrome
Recruiting
The Efficacy of an IADL-based Non-immersive Virtual Reality Training Program to Enhance ADL Performance and Cognitive Function for Persons at Risk of Dementia
Cognitive Enhancement, Subjective Cognitive Decline (SCD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Greg Stratmann, MD, PhD principal investigator
University of California, San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Deficits and Cognitive Ability, General, run by University of California, San Francisco at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recollection (time frame: 6-12 years of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2013.