Clinical Trial: Nitrous Oxide Induction Induces Amnesia in Pediatric Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Dose Response Effect of Nitrous Oxide on Amnesia in Healthy Children

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 Summary:

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 20-30% and third group will be nitrous oxide 60-70%. 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, 30 or 60%) 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 no
Sponsor: State University of New York at Buffalo

Current Primary Outcome: Nitrous Oxide effects on explicit memory [ 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 and implicit 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 to recall the joke they were told, the animal picture they were shown, the name of the food they heard and any odor they noticed as they fell asleep


Original Primary Outcome: Same as current

Current Secondary Outcome: Nitrous oxide effect on Implicit memory [ Time Frame: After recovery from anesthesia (in recovery room or before discharge from hospital) within 4 hours of anesthesia completion ]

Implicit memory will be tested if the child fails to identify any of the explicit tests by showing the child four animal pictures and picking an animal or by reciting four foods and asking the child to pick one.


Original Secondary Outcome: Same as current

Information By: State University of New York at Buffalo

Dates:
Date Received: March 22, 2013
Date Started: May 2013
Date Completion:
Last Updated: March 25, 2014
Last Verified: March 2014