Women and Children's Hospital of Buffalo
Buffalo, New York, 14222-2006, United States
NCT Number: NCT02050152
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.
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Notify Me6 year–12 year
All sexes
Interventional
Not applicable
Buffalo, New York, 14222-2006, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Behavior: recall at discharge from hospital will be tested for the content of photos and a joke told while breathing a mask
Other names: Placebo
Behavior: recall at discharge from hospital will be tested for the content of photos and a joke told while breathing a mask
Other names: low concentration Nitrous oxide
Behavior: recall at discharge from hospital will be tested for the content of photos and a joke told while breathing a mask
Other names: high concentration Nitrous oxide
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
State University of New York at Buffalo
Other
Dose Response Effect of Nitrous Oxide on Amnesia in Healthy Children
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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