Procedures Requiring AnesthesiaNCT02005185
Cognitive Effects of Anesthesia on Children
An observational study of Procedures Requiring Anesthesia, run by University of California, San Francisco at 3 sites in United States.
Trial summary
Anesthesia for more than 120 minutes given to children less than 2 years of age without coexisting diseases of the central nervous system or the heart cause long-term impairment of recognition memory. Read more about this study
- Who is it for?
- Ages 6 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Procedures Requiring Anesthesia
- How many people
- 162 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2013to 15 Nov 2018
- 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 11 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children currently 6-11 years old who have been anesthetized between ages 0-2 or between ages 4-7 and a matched group of children that did not undergo anesthesia.
Who may be able to join
- General anesthesia for more than 120 minutes between birth and 2 years of age or between ages 4-7
- General anesthesia for less than 30 minutes before the age of 2.
- Use of volatile anesthetic (sevoflurane, isoflurane, halothane or desflurane) with or without nitrous oxide for maintenance of anesthesia.
- Use of fentanyl or morphine as opioids and midazolam as premedication is acceptable. Propofol used for induction only is acceptable.
- Control subjects must never have been exposed to anesthesia or sedation for any procedure.
- English and Spanish speaking subjects
Who cannot join
- Use of any other agents such as ketamine, meperidine, barbiturates, etomidate, methoxyflurane, chloral hydrate, methadone or lorazepam.
- Low birth weight (<25th percentile)
- premature birth at <36 weeks
- color blindness
- history of brain disease including head trauma
- presence of congenital heart disease
Show all 13Show fewer
- any other metabolic disease (i.e. diabetes),cancer, or known genetic syndrome.
- significant low blood pressure during their surgery (<30% of baseline for >5min)
- abnormal temperature (deviation from 36.5 degrees C by >1.5 degree C at any point)
- slow heart rate
- low blood oxygen saturation (<93% for >5min.)
- high arterial carbon dioxide levels (>60mm Hg for >5min.)
- control subjects are excluded for any exposure to anesthesia or sedation
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of California, Davis Center for Mind and Brain
Davis, California, 95618
UCSF Benioff Children's Hospital Oakland
Oakland, California, 94609
UCSF
San Francisco, California, 94143
About this study
Official title: Is Pediatric Anesthesia Associated With Long-term Hippocampal Dysfunction?
Anesthesia for more than 120 minutes given to children less than 2 years of age without coexisting diseases of the central nervous system or the heart cause long-term impairment of recognition memory.
Read the detailed description
If the subject enrolls in the study, the child will undergo testing for 1) memory, 2) general brain function (i.e. intelligence testing). The parent will complete 3) a parental assessment of the subject's behavior through a standardized questionnaire.
Initial testing of all case and control participants will include an assessment for neurologic and psychiatric conditions, including attention deficit or learning disorders. In addition, each participant will be assessed by the Wechsler Abbreviated Scale of Intelligence (WASI) and the Child Behavioral Checklist (CBCL), which measures children's psychological well-being, competencies and behavioral/emotional problems.
After explaining the study to your child, we will show your child 80 items on a computer screen with a colored border in either in red, green, blue, or yellow. Following a short break, we will show your child 160 items on the screen. Half of these items were previously displayed and half of these items are new. We will ask your child two or three questions: Have we shown you this item before?How sure are you about your response? Your child will be given the choice of one of three categories: Very sure / halfway sure / not sure. What color was it? This question will only be asked if the answer to question 1 was yes.This portion of the test takes about 30 min. Subjects will then participate in a similar test of picture recognition, but we will ask about the location of the original image instead of the color. Your child will then be given a standardized intelligence test. This takes roughly 45 min to an hour to complete.
Some test participants will partake in a reading portion where the test administrator will read a passage to the participant and the child will say whether or not they recognize a series of phrases. This should take about 20 min to complete. Participants are read a passage and presented with a series of sentences. After listening to the text, they will be informed that some of the sentences they will hear are part of the text, whereas other sentences are new. They will be asked to circle "yes" on their answer sheet when they recognize the sentence as being taken directly from the text, and "no" when they think the sentence was not taken from the text and has not been heard before. It will be emphasized that participants must recognize as old only those sentences that included exactly the same words as the sentences encountered in the text. Participants will also be told that for every "yes" answer they would have to select the option "Remember" if they have a clear memory of their encounter with the sentence in mind, and they can further remember some qualitative and contextual information related to the memory itself, or select the option "Familiar" if they have the feeling that the sentence is part of the text story but they cannot recollect any qualitative detail about the encoding of the sentence.
- Conditions
- Procedures Requiring Anesthesia
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 |
|---|---|---|
| 6-11y/o anesthetized at 0-2y/o for >2hrs | 6-11yr olds anesthetized for more than120 minutes before the age of 2. | |
| 6-11y/o anesthetized @ 0-2y/o for <30min | 6-11 year olds anesthetized for < 30min before the age of 2. | |
| 6-11y/o anesthetized at 4-7y/o for >2hrs | 6-11 year olds anesthetized for more than 120 min between the ages of 4-7. | |
| 6-11 y/o healthy control | 6-11 year olds that have never received general anesthesia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Examine memory in 6-11 year old children
Assess recognition memory using DPSD model in 6-11 year old children
Measured: 2-3 hours/subject
Secondary outcomes (1)
Additional Neuropsychological evaluations
WASI-2, CBCL, listening/reading comprehension (in 8-11 year olds), digit span
Measured: 2-3 hours/subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startNov 2013
- Primary completion15 Nov 2018
- Study completion15 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Procedures Requiring AnesthesiaStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Davis, UCSF Benioff Children's Hospital Oakland
- Responsible party
- Sponsor
- Investigators
- Jeffrey Sall, M.D., PhD, Principal investigator, Anesthesiologist, Professor, Researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02005185
- Sponsor's protocol ID
- Anes255HippocampalDysfcn
- Status last verified
- Sep 2020
- First submitted
- 3 Dec 2013
- Last updated
- 11 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2020. 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
- NCT02005185
- Acronym / sponsor ID
- Anes255HippocampalDysfcn
- Conditions
- Procedures Requiring Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- University of California, Davis, UCSF Benioff Children's Hospital Oakland
- Study start
- Nov 2013
- Primary completion
- 15 Nov 2018 (actual)
- Study completion
- 15 Nov 2018 (actual)
- First posted
- 9 Dec 2013 (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.
Anesthesia for more than 120 minutes given to children less than 2 years of age without coexisting diseases of the central nervous system or the heart cause long-term impairment of recognition memory.
Detailed description
If the subject enrolls in the study, the child will undergo testing for 1) memory, 2) general brain function (i.e. intelligence testing). The parent will complete 3) a parental assessment of the subject's behavior through a standardized questionnaire.
Initial testing of all case and control participants will include an assessment for neurologic and psychiatric conditions, including attention deficit or learning disorders. In addition, each participant will be assessed by the Wechsler Abbreviated Scale of Intelligence (WASI) and the Child Behavioral Checklist (CBCL), which measures children's psychological well-being, competencies and behavioral/emotional problems.
After explaining the study to your child, we will show your child 80 items on a computer screen with a colored border in either in red, green, blue, or yellow. Following a short break, we will show your child 160 items on the screen. Half of these items were previously displayed and half of these items are new. We will ask your child two or three questions: Have we shown you this item before?How sure are you about your response? Your child will be given the choice of one of three categories: Very sure / halfway sure / not sure. What color was it? This question will only be asked if the answer to question 1 was yes.This portion of the test takes about 30 min. Subjects will then participate in a similar test of picture recognition, but we will ask about the location of the original image instead of the color. Your child will then be given a standardized intelligence test. This takes roughly 45 min to an hour to complete.
Some test participants will partake in a reading portion where the test administrator will read a passage to the participant and the child will say whether or not they recognize a series of phrases. This should take about 20 min to complete. Participants are read a passage and presented with a series of sentences. After listening to the text, they will be informed that some of the sentences they will hear are part of the text, whereas other sentences are new. They will be asked to circle "yes" on their answer sheet when they recognize the sentence as being taken directly from the text, and "no" when they think the sentence was not taken from the text and has not been heard before. It will be emphasized that participants must recognize as old only those sentences that included exactly the same words as the sentences encountered in the text. Participants will also be told that for every "yes" answer they would have to select the option "Remember" if they have a clear memory of their encounter with the sentence in mind, and they can further remember some qualitative and contextual information related to the memory itself, or select the option "Familiar" if they have the feeling that the sentence is part of the text story but they cannot recollect any qualitative detail about the encoding of the sentence.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 6-11y/o anesthetized at 0-2y/o for >2hrs | – | –6-11yr olds anesthetized for more than120 minutes before the age of 2. |
| 6-11y/o anesthetized @ 0-2y/o for <30min | – | –6-11 year olds anesthetized for < 30min before the age of 2. |
| 6-11y/o anesthetized at 4-7y/o for >2hrs | – | –6-11 year olds anesthetized for more than 120 min between the ages of 4-7. |
| 6-11 y/o healthy control | – | –6-11 year olds that have never received general anesthesia. |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children currently 6-11 years old who have been anesthetized between ages 0-2 or between ages 4-7 and a matched group of children that did not undergo anesthesia.
Key inclusion criteria (6 listed)
- General anesthesia for more than 120 minutes between birth and 2 years of age or between ages 4-7
- General anesthesia for less than 30 minutes before the age of 2.
- Use of volatile anesthetic (sevoflurane, isoflurane, halothane or desflurane) with or without nitrous oxide for maintenance of anesthesia.
- Use of fentanyl or morphine as opioids and midazolam as premedication is acceptable. Propofol used for induction only is acceptable.
- Control subjects must never have been exposed to anesthesia or sedation for any procedure.
Key exclusion criteria (13 listed)
- Use of any other agents such as ketamine, meperidine, barbiturates, etomidate, methoxyflurane, chloral hydrate, methadone or lorazepam.
- Low birth weight (<25th percentile)
- premature birth at <36 weeks
- color blindness
- history of brain disease including head trauma
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
Examine memory in 6-11 year old children
Time frame: 2-3 hours/subject
Assess recognition memory using DPSD model in 6-11 year old children
1 secondary outcome
Additional Neuropsychological evaluations
Time frame: 2-3 hours/subject
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 11 Sep 2020.
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.
Jeffrey Sall, M.D., PhD principal investigator
Anesthesiologist, Professor, Researcher
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Procedures Requiring Anesthesia, run by University of California, San Francisco at 3 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 6 inclusion and 13 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 11 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Examine memory in 6-11 year old children (time frame: 2-3 hours/subject). 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 11 Sep 2020.