Nitrous Oxide Induction Induces Amnesia in Pediatric Patients

Amnesia Clinical Trial

Official title:

Dose Response Effect of Nitrous Oxide on Amnesia in Healthy Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02050152
• Other study ID #: Nitrous Oxide Amnesia Children
• Status: Completed
• Phase: N/A
• First received: March 22, 2013
• Last updated: March 25, 2014
• Start date: May 2013
• Est. completion date: October 2013

Study information

• Verified date: March 2014
• Source: State University of New York at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor)

Related Conditions & MeSH terms

• Amnesia

Intervention

Behavioral:
• 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)

Drug:
• 0% nitrous oxide, 30% nitrous oxide and 60% nitrous oxide

Locations

Country	Name	City	State
United States	Women and Children's Hospital of Buffalo	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York at Buffalo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nitrous Oxide effects on explicit memory	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	After full recovery from anesthesia (generally by 2 hours after termination of anesthesia), but before discharge from hospital all variables will be assessed	No
Secondary	Nitrous oxide effect on Implicit memory	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.	After recovery from anesthesia (in recovery room or before discharge from hospital) within 4 hours of anesthesia completion	No