Cognitive Effects of Anesthesia on Children

NCT02005185 | Completed

• 1 other identifier: Anes255HippocampalDysfcn
• Study Type: observational
• Target: 162
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Procedures Requiring Anesthesia

Outcome Measures

Primary Outcomes (1)

• Examine memory in 6-11 year old children

  Assess recognition memory using DPSD model in 6-11 year old children

  2-3 hours/subject

Secondary Outcomes (1)

• Additional Neuropsychological evaluations

  2-3 hours/subject

Study Arms (4)

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.

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• University of California, Davis: collaborator
• UCSF Benioff Children's Hospital Oakland: collaborator

Study Sites (3)

University of California, Davis Center for Mind and Brain

Davis, California, 95618, United States

Location

UCSF Benioff Children's Hospital Oakland

Oakland, California, 94609, United States

Location

UCSF

San Francisco, California, 94143, United States

Location

Study Officials

• Jeffrey Sall, M.D., PhD

  Anesthesiologist, Professor, Researcher

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 3, 2013
• First Posted: December 9, 2013
• Study Start: November 1, 2013
• Primary Completion: November 15, 2018
• Study Completion: November 15, 2018
• Last Updated: September 11, 2020

Record last verified: 2020-09

Locations

US (3)