Trial Outcomes & Findings for Nitrous Oxide Induction Induces Amnesia in Pediatric Patients (NCT NCT02050152)
NCT ID: NCT02050152
Last Updated: 2026-06-30
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
90 participants
Primary outcome timeframe
After full recovery from anesthesia (generally by 2 hours after termination of anesthesia), but before discharge from hospital all variables will be assessed
Results posted on
2026-06-30
Participant Flow
Participant milestones
| Measure |
0% Nitrous Oxide
Explicit and implicit memory will be tested in 0% nitrous oxide
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)
0% nitrous oxide, 30% nitrous oxide and 60% nitrous oxide
|
30% Nitrous Oxide
Explicit and Implicit memory in 30% nitrous oxide
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)
0% nitrous oxide, 30% nitrous oxide and 60% nitrous oxide
|
60% Nitrous Oxide
Explicit and Implicit memory with 60% nitrous oxide
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)
0% nitrous oxide, 30% nitrous oxide and 60% nitrous oxide
|
|---|---|---|---|
|
Overall Study
STARTED
|
30
|
29
|
31
|
|
Overall Study
COMPLETED
|
30
|
29
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nitrous Oxide Induction Induces Amnesia in Pediatric Patients
Baseline characteristics by cohort
| Measure |
0% Nitrous Oxide
n=30 Participants
Explicit and implicit memory will be tested in 0% nitrous oxide
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)
0% nitrous oxide, 30% nitrous oxide and 60% nitrous oxide
|
30% Nitrous Oxide
n=29 Participants
Explicit and Implicit memory in 30% nitrous oxide
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)
0% nitrous oxide, 30% nitrous oxide and 60% nitrous oxide
|
60% Nitrous Oxide
n=31 Participants
Explicit and Implicit memory with 60% nitrous oxide
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)
0% nitrous oxide, 30% nitrous oxide and 60% nitrous oxide
|
Total
n=180 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
8.3 years
STANDARD_DEVIATION 1.9 • n=30 Participants
|
8.2 years
STANDARD_DEVIATION 1.6 • n=29 Participants
|
8.2 years
STANDARD_DEVIATION 1.9 • n=31 Participants
|
8.2 years
STANDARD_DEVIATION 1.8 • n=90 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=30 Participants
|
23 Participants
n=29 Participants
|
17 Participants
n=31 Participants
|
55 Participants
n=90 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=30 Participants
|
6 Participants
n=29 Participants
|
14 Participants
n=31 Participants
|
35 Participants
n=90 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=30 Participants
|
29 participants
n=29 Participants
|
31 participants
n=31 Participants
|
90 participants
n=90 Participants
|
PRIMARY outcome
Timeframe: After full recovery from anesthesia (generally by 2 hours after termination of anesthesia), but before discharge from hospital all variables will be assessedExplicit 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.
Outcome measures
| Measure |
Nitrous Oxide 0%
n=30 Participants
Nitrous oxide 0% by mask for 2 minutes while showing pictures and telling a riddle.
Nitrous Oxide 0%: Behavior: recall at discharge from hospital will be tested for the content of photos and a riddle told while breathing a mask
|
Nitrous Oxide 33%
n=29 Participants
Nitrous oxide 33% for 2 minutes while showing pictures and telling a riddle.
Nitrous oxide 33%: Behavior: recall at discharge from hospital will be tested for the content of photos and a riddle told while breathing a mask
|
Nitrous Oxide 66%
n=31 Participants
Nitrous oxide 66% for 2 minutes while showing pictures and telling a riddle.
Nitrous oxide 66%: Behavior: recall at discharge from hospital will be tested for the content of photos and a riddle told while breathing a mask
|
|---|---|---|---|
|
Explicit Memory
|
7 participants
|
1 participants
|
2 participants
|
SECONDARY outcome
Timeframe: After recovery from anesthesia (in recovery room or before discharge from hospital) within 4 hours of anesthesia completionExplicit memory will be tested for the child recalling the riddle and answer after the study
Outcome measures
| Measure |
Nitrous Oxide 0%
n=30 Participants
Nitrous oxide 0% by mask for 2 minutes while showing pictures and telling a riddle.
Nitrous Oxide 0%: Behavior: recall at discharge from hospital will be tested for the content of photos and a riddle told while breathing a mask
|
Nitrous Oxide 33%
n=29 Participants
Nitrous oxide 33% for 2 minutes while showing pictures and telling a riddle.
Nitrous oxide 33%: Behavior: recall at discharge from hospital will be tested for the content of photos and a riddle told while breathing a mask
|
Nitrous Oxide 66%
n=31 Participants
Nitrous oxide 66% for 2 minutes while showing pictures and telling a riddle.
Nitrous oxide 66%: Behavior: recall at discharge from hospital will be tested for the content of photos and a riddle told while breathing a mask
|
|---|---|---|---|
|
Explicit Memory
|
21 Participants
|
21 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: 2 hours after anesthesiaThe 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
Outcome measures
| Measure |
Nitrous Oxide 0%
n=30 Participants
Nitrous oxide 0% by mask for 2 minutes while showing pictures and telling a riddle.
Nitrous Oxide 0%: Behavior: recall at discharge from hospital will be tested for the content of photos and a riddle told while breathing a mask
|
Nitrous Oxide 33%
n=29 Participants
Nitrous oxide 33% for 2 minutes while showing pictures and telling a riddle.
Nitrous oxide 33%: Behavior: recall at discharge from hospital will be tested for the content of photos and a riddle told while breathing a mask
|
Nitrous Oxide 66%
n=31 Participants
Nitrous oxide 66% for 2 minutes while showing pictures and telling a riddle.
Nitrous oxide 66%: Behavior: recall at discharge from hospital will be tested for the content of photos and a riddle told while breathing a mask
|
|---|---|---|---|
|
Explicit Memory if the Child Remembered Being Shown an Animal in a Photo
|
27 Participants
|
21 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: 2 hours after anesthesiaThe child will be asked if they recall hearing the name of a good that began with the letter "b" while breathing the mask
Outcome measures
| Measure |
Nitrous Oxide 0%
n=30 Participants
Nitrous oxide 0% by mask for 2 minutes while showing pictures and telling a riddle.
Nitrous Oxide 0%: Behavior: recall at discharge from hospital will be tested for the content of photos and a riddle told while breathing a mask
|
Nitrous Oxide 33%
n=29 Participants
Nitrous oxide 33% for 2 minutes while showing pictures and telling a riddle.
Nitrous oxide 33%: Behavior: recall at discharge from hospital will be tested for the content of photos and a riddle told while breathing a mask
|
Nitrous Oxide 66%
n=31 Participants
Nitrous oxide 66% for 2 minutes while showing pictures and telling a riddle.
Nitrous oxide 66%: Behavior: recall at discharge from hospital will be tested for the content of photos and a riddle told while breathing a mask
|
|---|---|---|---|
|
Explicit Memory of the Name of a Food That Begins With the Letter "b"
|
10 Participants
|
15 Participants
|
7 Participants
|
Adverse Events
Nitrous Oxide 0%
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Nitrous Oxide 30%
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Nitrous Oxide 60%
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Jerrold Lerman, Clinical Professor of Anesthesiology
Women and Children's Hospital of Buffalo, SUNY at Buffalo
Phone: 716-878-7701
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place