Nitrous Oxide Induction Induces Amnesia in Pediatric Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jerrold Lerman, State University of New York at Buffalo
ClinicalTrials.gov Identifier:
NCT02050152
First received: March 22, 2013
Last updated: March 25, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Amnesia
Behavioral: Explicit and Implicit memory
Drug: 0% nitrous oxide, 30% nitrous oxide and 60% nitrous oxide

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Official Title: Dose Response Effect of Nitrous Oxide on Amnesia in Healthy Children

Resource links provided by NLM:


Further study details as provided by State University of New York at Buffalo:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 90
Study Start Date: May 2013
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 0% nitrous oxide
Explicit and implicit memory will be tested in 0% nitrous oxide
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
Active Comparator: 30% nitrous oxide
Explicit and Implicit memory in 30% nitrous oxide
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
Active Comparator: 60% nitrous oxide
Explicit and Implicit memory with 60% nitrous oxide
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

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 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.

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02050152

Locations
United States, New York
Women and Children's Hospital of Buffalo
Buffalo, New York, United States, 14222-2006
Sponsors and Collaborators
State University of New York at Buffalo
Investigators
Principal Investigator: Jerrold Lerman, MD, FRCPC Professor
  More Information

No publications provided

Responsible Party: Jerrold Lerman, Clinical Professor of Anesthesiology, State University of New York at Buffalo
ClinicalTrials.gov Identifier: NCT02050152     History of Changes
Other Study ID Numbers: Nitrous Oxide Amnesia Children
Study First Received: March 22, 2013
Last Updated: March 25, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by State University of New York at Buffalo:
Amnesia
Memory
Implicit
Explicit
Nitrous Oxide

Additional relevant MeSH terms:
Amnesia
Memory Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nitrous Oxide
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014