AmnesiaNCT02050152
Nitrous Oxide Induction Induces Amnesia in Pediatric Patients
A study testing Nitrous Oxide 0%, Nitrous oxide 33% and Nitrous oxide 66% in people with Amnesia, run by State University of New York at Buffalo at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Amnesia
- What is being tested?
- Nitrous Oxide 0%, Nitrous oxide 33% and Nitrous oxide 66%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Oct 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age: 6-12 years old,
- ASA classification: 1 and 2
- Elective surgery
Who cannot join
- Uncooperative child needs sedation before induction of anesthesia
- Developmental delay, ADHD, autism, Tourette's syndrome, schizophrenia, congenital and acquired brain disorder, Down syndrome.
- Those who request for IV induction
- Those taking sedative medications, anti-seizure medication
- Those with malignant hyperthermia, muscular dystrophy; those with uncorrected cardiac defects and those with severe or active lung disease
- Those with elective admissions to PICU with ongoing sedation and tracheal intubation
Trial locations and contacts
1 site in 1 country.
United States1 site
Women and Children's Hospital of Buffalo
Buffalo, New York, 14222-2006
About this study
Official title: Dose Response Effect of Nitrous Oxide on Amnesia in Healthy Children
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.
Read the 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 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.
- Conditions
- Amnesia
- Being tested
- Nitrous Oxide 0%, Nitrous oxide 33%, Nitrous oxide 66%
- Keywords
- Amnesia, Memory, Implicit, Explicit, Nitrous Oxide
- Medical subject headings
- Amnesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitrous Oxide 0%Drug
Also called Placebo
Behavior: recall at discharge from hospital will be tested for the content of photos and a joke told while breathing a mask
Nitrous oxide 33%Drug
Also called 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
Nitrous oxide 66%Drug
Also called high 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
| Study group | Role | What they receive |
|---|---|---|
| Nitrous oxide 0% | Placebo comparator | Nitrous oxide 0% by mask for 2 minutes while showing pictures and telling jokes. Receives: Drug: Nitrous Oxide 0% |
| Nitrous oxide 33% | Active comparator | Nitrous oxide 33% for 2 minutes while showing pictures and telling jokes. Receives: Drug: Nitrous oxide 33% |
| Nitrous oxide 66% | Active comparator | Nitrous oxide 66% for 2 minutes while showing pictures and telling jokes. Receives: Drug: Nitrous oxide 66% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After full recovery from anesthesia (generally by 2 hours after termination of anesthesia), but before discharge from hospital all variables will be assessed
Secondary outcomes (3)
Explicit Memory
Explicit memory will be tested for the child recalling the riddle and answer after the study
Measured: 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
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
Measured: 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
Measured: 2 hours after anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2014 (estimated)
- Study startMay 2013
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AmnesiaStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jerrold Lerman, State University of New York at Buffalo
- Investigators
- Jerrold Lerman, MD, FRCPC, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02050152
- Sponsor's protocol ID
- Nitrous Oxide Amnesia Children
- Status last verified
- May 2026
- First submitted
- 22 Mar 2013
- Last updated
- 30 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Response Effect of Nitrous Oxide on Amnesia in Healthy Children
- ClinicalTrials.gov ID
- NCT02050152
- Acronym / sponsor ID
- Nitrous Oxide Amnesia Children
- Conditions
- Amnesia
- Keywords
- Amnesia, Memory, Implicit, Explicit, Nitrous Oxide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 30 Jan 2014 (estimated)
- Results
- Posted 30 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nitrous oxide 0% | Placebo comparator | Drug: Nitrous Oxide 0%Nitrous oxide 0% by mask for 2 minutes while showing pictures and telling jokes. |
| Nitrous oxide 33% | Active comparator | Drug: Nitrous oxide 33%Nitrous oxide 33% for 2 minutes while showing pictures and telling jokes. |
| Nitrous oxide 66% | Active comparator | Drug: Nitrous oxide 66%Nitrous oxide 66% for 2 minutes while showing pictures and telling jokes. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age: 6-12 years old,
- ASA classification: 1 and 2
- Elective surgery
Key exclusion criteria (6 listed)
- Uncooperative child needs sedation before induction of anesthesia
- Developmental delay, ADHD, autism, Tourette's syndrome, schizophrenia, congenital and acquired brain disorder, Down syndrome.
- Those who request for IV induction
- Those taking sedative medications, anti-seizure medication
- Those with malignant hyperthermia, muscular dystrophy; those with uncorrected cardiac defects and those with severe or active lung disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nitrous Oxide 0%Also: PlaceboBehavior: recall at discharge from hospital will be tested for the content of photos and a joke told while breathing a mask | Drug | Nitrous oxide 0% |
| Nitrous oxide 33%Also: low concentration Nitrous oxideBehavior: recall at discharge from hospital will be tested for the content of photos and a joke told while breathing a mask | Drug | Nitrous oxide 33% |
| Nitrous oxide 66%Also: high concentration Nitrous oxideBehavior: recall at discharge from hospital will be tested for the content of photos and a joke told while breathing a mask | Drug | Nitrous oxide 66% |
Primary outcome
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 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.
3 secondary outcomes
Explicit Memory
Time frame: 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
Time frame: 2 hours after anesthesia
Explicit Memory of the Name of a Food That Begins With the Letter "b"
Time frame: 2 hours after anesthesia
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jerrold Lerman, MD, FRCPC principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nitrous Oxide 0%, Nitrous oxide 33% and Nitrous oxide 66% in people with Amnesia, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.