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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nitrous oxide 0% | Placebo Comparator | Nitrous oxide 0% by mask for 2 minutes while showing pictures and telling jokes. |
|
| Nitrous oxide 33% | Active Comparator | Nitrous oxide 33% for 2 minutes while showing pictures and telling jokes. |
|
| Nitrous oxide 66% | Active Comparator | Nitrous oxide 66% for 2 minutes while showing pictures and telling jokes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nitrous Oxide 0% | Drug | Behavior: recall at discharge from hospital will be tested for the content of photos and a joke told while breathing a mask |
|
| Measure | Description | Time Frame |
|---|---|---|
| Explicit Memory | 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. | After full recovery from anesthesia (generally by 2 hours after termination of anesthesia), but before discharge from hospital all variables will be assessed |
| Measure | Description | Time Frame |
|---|---|---|
| Explicit Memory | Explicit memory will be tested for the child recalling the riddle and answer after the study | After recovery from anesthesia (in recovery room or before discharge from hospital) within 4 hours of anesthesia completion |
| Explicit Memory if the Child Remembered Being Shown an Animal in a Photo |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jerrold Lerman, MD, FRCPC | Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women and Children's Hospital of Buffalo | Buffalo | New York | 14222-2006 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 0% Nitrous Oxide | Explicit and implicit memory will be tested in 0% nitrous oxide Explicit and Implicit memory: Explicit and implicit memory will be tested visually (showing an animal) and auditory (telling a joke, stating a food type that starts with the letter B) and smell recall (bad smell of anesthesia) 0% nitrous oxide, 30% nitrous oxide and 60% nitrous oxide |
| FG001 | 30% Nitrous Oxide | Explicit and Implicit memory in 30% nitrous oxide Explicit and Implicit memory: Explicit and implicit memory will be tested visually (showing an animal) and auditory (telling a joke, stating a food type that starts with the letter B) and smell recall (bad smell of anesthesia) 0% nitrous oxide, 30% nitrous oxide and 60% nitrous oxide |
| FG002 | 60% Nitrous Oxide | Explicit and Implicit memory with 60% nitrous oxide Explicit and Implicit memory: Explicit and implicit memory will be tested visually (showing an animal) and auditory (telling a joke, stating a food type that starts with the letter B) and smell recall (bad smell of anesthesia) 0% nitrous oxide, 30% nitrous oxide and 60% nitrous oxide |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Children 6-12 years, ASA physical status 1 or 2
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| ID | Title | Description |
|---|---|---|
| BG000 | 0% Nitrous Oxide | Explicit and implicit memory will be tested in 0% nitrous oxide Explicit and Implicit memory: Explicit and implicit memory will be tested visually (showing an animal) and auditory (telling a joke, stating a food type that starts with the letter B) and smell recall (bad smell of anesthesia) 0% nitrous oxide, 30% nitrous oxide and 60% nitrous oxide |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Explicit Memory | 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. | Posted | Number | participants | After full recovery from anesthesia (generally by 2 hours after termination of anesthesia), but before discharge from hospital all variables will be assessed |
|
During the day of surgery, 1 day.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nitrous Oxide 0% | Nitrous oxide 0% by mask for 2 minutes while showing pictures and telling jokes. Nitrous Oxide 0%: Behavior: recall at discharge from hospital will be tested for the content of photos and a joke told while breathing a mask |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jerrold Lerman, Clinical Professor of Anesthesiology | Women and Children's Hospital of Buffalo, SUNY at Buffalo | 716-878-7701 | jlerman@buffalo.edu |
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| ID | Term |
|---|---|
| D000647 | Amnesia |
| ID | Term |
|---|---|
| D008569 | Memory Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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|
| Nitrous oxide 33% | Drug | Behavior: recall at discharge from hospital will be tested for the content of photos and a joke told while breathing a mask |
|
|
| Nitrous oxide 66% | Drug | Behavior: recall at discharge from hospital will be tested for the content of photos and a joke told while breathing a mask |
|
|
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 |
| 2 hours after anesthesia |
| Explicit Memory of the Name of a Food That Begins With the Letter "b" | The child will be asked if they recall hearing the name of a good that began with the letter "b" while breathing the mask | 2 hours after anesthesia |
| BG001 |
| 30% Nitrous Oxide |
Explicit and Implicit memory in 30% nitrous oxide Explicit and Implicit memory: Explicit and implicit memory will be tested visually (showing an animal) and auditory (telling a joke, stating a food type that starts with the letter B) and smell recall (bad smell of anesthesia) 0% nitrous oxide, 30% nitrous oxide and 60% nitrous oxide |
| BG002 | 60% Nitrous Oxide | Explicit and Implicit memory with 60% nitrous oxide Explicit and Implicit memory: Explicit and implicit memory will be tested visually (showing an animal) and auditory (telling a joke, stating a food type that starts with the letter B) and smell recall (bad smell of anesthesia) 0% nitrous oxide, 30% nitrous oxide and 60% nitrous oxide |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Nitrous oxide 33% for 2 minutes while showing pictures and telling a riddle. Nitrous oxide 33%: Behavior: recall at discharge from hospital will be tested for the content of photos and a riddle told while breathing a mask |
| OG002 | Nitrous Oxide 66% | Nitrous oxide 66% for 2 minutes while showing pictures and telling a riddle. Nitrous oxide 66%: Behavior: recall at discharge from hospital will be tested for the content of photos and a riddle told while breathing a mask |
|
|
| Secondary | Explicit Memory | Explicit memory will be tested for the child recalling the riddle and answer after the study | Posted | Count of Participants | Participants | After recovery from anesthesia (in recovery room or before discharge from hospital) within 4 hours of anesthesia completion |
|
|
|
| Secondary | Explicit Memory if the Child Remembered Being Shown an Animal in a Photo | 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 | Posted | Count of Participants | Participants | 2 hours after anesthesia |
|
|
|
| Secondary | Explicit Memory of the Name of a Food That Begins With the Letter "b" | The child will be asked if they recall hearing the name of a good that began with the letter "b" while breathing the mask | Posted | Count of Participants | Participants | 2 hours after anesthesia |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Nitrous Oxide 30% | Nitrous oxide 30% end-tidal concentration by mask for 2 minutes while showing pictures and telling jokes. Nitrous oxide 30%: Behavior: recall at discharge from hospital will be tested for the content of photos and a joke told while breathing a mask | 0 | 29 | 0 | 29 | 0 | 29 |
| EG002 | Nitrous Oxide 60% | Nitrous oxide 60% end-tidal concentration by mask for 2 minutes while showing pictures and telling jokes. Nitrous oxide 60%: Behavior: recall at discharge from hospital will be tested for the content of photos and a joke told while breathing a mask | 0 | 31 | 0 | 31 | 0 | 31 |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| Male |
|