Amnesia
Conditions
Keywords
Amnesia, Memory, Implicit, Explicit, Nitrous Oxide
Brief summary
The investigators are conducting a study to investigate the amnestic effects of 2 different concentrations of nitrous oxide in children before induction of anesthesia in a prospective double-blinded placebo controlled study.
Detailed description
Children of age group 6-12 will be randomly divided in 3 groups, First group will be Placebo , second group will be nitrous oxide end tidal 33% and third group will be nitrous oxide 66%. Each group will be divided into 2 subgroups randomly with either a flavored or unflavored mask for induction. All children will be told a joke before the mask is applied, with the answer provided after the end-tidal nitrous oxide concentration reaches the randomized concentration (0, 33 or 66%) for at least one minute. At that point, the child will randomized to be either shown a picture of one of four animals (predetermined randomly) or a food will be stated aloud. For the animal, the child will be asked to name the animal aloud. The child's response (yes or no to a response and whether the item is correctly named) will be recorded. If the child does not respond, the name of the animal will be stated out loud. For the food, one of four foods will be named aloud and child will be asked to repeat the name. The child's response (named or not) will be recorded. Anesthesia will continue with the designated nitrous oxide concentration combined with 8% Sevoflurane. When the child is ready for discharge from the recovery room and recovered from anesthesia, a nurse or doctor who is blinded to the treatment group assignment will ask the child to recall the joke and answer. The child will then be asked if they were shown any animals and if so, which animal? If the child cannot recall an animal, the child will be asked to name the first animal that comes to mind. The child will then be shown pictures of four animals and asked to identify one. The child will be asked if they heard any foods when they went to sleep? If the child cannot recall hearing any foods recited, the first letter of the food will be shown: B \_ \_ \_ \_ \_ . If the child does not recall any foods, then the child will be given the names of four foods that begin with the letter B and asked to pick one. Finally, the child will be asked about any odors in the mask during anesthesia. If he/she does not recall, then four odors will be read out and the child asked to identify any one. Additionally, the children will be asked whether they recall any odors on the mask as they were anesthetized. The order of items questioned in the recovery period will follow the same order as in the OR.
Interventions
DRUGNitrous Oxide 0%
Behavior: recall at discharge from hospital will be tested for the content of photos and a joke told while breathing a mask
DRUGNitrous oxide 33%
Behavior: recall at discharge from hospital will be tested for the content of photos and a joke told while breathing a mask
DRUGNitrous oxide 66%
Behavior: recall at discharge from hospital will be tested for the content of photos and a joke told while breathing a mask
Sponsors
State University of New York at Buffalo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
1. Age: 6-12 years old, 2. ASA classification: 1 and 2 3. Elective surgery
Exclusion criteria
1. Uncooperative child needs sedation before induction of anesthesia 2. Developmental delay, ADHD, autism, Tourette's syndrome, schizophrenia, congenital and acquired brain disorder, Down syndrome. 3. Those who request for IV induction 4. Those taking sedative medications, anti-seizure medication 5. Those with malignant hyperthermia, muscular dystrophy; those with uncorrected cardiac defects and those with severe or active lung disease 6. Those with elective admissions to PICU with ongoing sedation and tracheal intubation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Explicit Memory | After full recovery from anesthesia (generally by 2 hours after termination of anesthesia), but before discharge from hospital all variables will be assessed | Explicit memory will be tested during the recovery period (once the child has fully recovered from anesthesia but before discharge from hospital) by a blinded observer who will ask the child whether they smelled za bad odor while they breathed through the mask. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Explicit Memory | After recovery from anesthesia (in recovery room or before discharge from hospital) within 4 hours of anesthesia completion | Explicit memory will be tested for the child recalling the riddle and answer after the study |
| Explicit Memory if the Child Remembered Being Shown an Animal in a Photo | 2 hours after anesthesia | The child will be shown the photo of an animal while they were breathing through the mask and then asked to recall which animal they were shown in the photo during the mask induction |
| Explicit Memory of the Name of a Food That Begins With the Letter "b" | 2 hours after anesthesia | The child will be asked if they recall hearing the name of a good that began with the letter "b" while breathing the mask |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJerrold Lerman, MD, FRCPC
Professor
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 8.2 years STANDARD_DEVIATION 1.8 |
| Region of Enrollment United States | 31 participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 29 | 0 / 31 |
| other Total, other adverse events | 0 / 30 | 0 / 29 | 0 / 31 |
| serious Total, serious adverse events | 0 / 30 | 0 / 29 | 0 / 31 |
Outcome results
None listed