NCT02050152

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 30, 2014

Completed
Last Updated

March 27, 2014

Status Verified

March 1, 2014

Enrollment Period

5 months

First QC Date

March 22, 2013

Last Update Submit

March 25, 2014

Conditions

Amnesia

Keywords

AmnesiaMemoryImplicitExplicitNitrous Oxide

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Nitrous oxide effect on Implicit memory

    After recovery from anesthesia (in recovery room or before discharge from hospital) within 4 hours of anesthesia completion

Study Arms (3)

0% nitrous oxide

PLACEBO COMPARATOR

Explicit and implicit memory will be tested in 0% nitrous oxide

Behavioral: Explicit and Implicit memoryDrug: 0% nitrous oxide, 30% nitrous oxide and 60% nitrous oxide

30% nitrous oxide

ACTIVE COMPARATOR

Explicit and Implicit memory in 30% nitrous oxide

Behavioral: Explicit and Implicit memoryDrug: 0% nitrous oxide, 30% nitrous oxide and 60% nitrous oxide

60% nitrous oxide

ACTIVE COMPARATOR

Explicit and Implicit memory with 60% nitrous oxide

Behavioral: Explicit and Implicit memoryDrug: 0% nitrous oxide, 30% nitrous oxide and 60% nitrous oxide

Interventions

Explicit and Implicit memoryBEHAVIORAL

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 oxide30% nitrous oxide60% nitrous oxide
0% nitrous oxide, 30% nitrous oxide and 60% nitrous oxideDRUG
0% nitrous oxide30% nitrous oxide60% nitrous oxide

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age: 6-12 years old,
  • ASA classification: 1 and 2
  • Elective surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women and Children's Hospital of Buffalo

Buffalo, New York, 14222-2006, United States

Location

MeSH Terms

Conditions

Amnesia

Interventions

Nitrous Oxide

Condition Hierarchy (Ancestors)

Memory DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Nitrogen OxidesGasesInorganic ChemicalsNitrogen CompoundsOxidesOxygen Compounds

Study Officials

  • Jerrold Lerman, MD, FRCPC

    Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor of Anesthesiology

Study Record Dates

First Submitted

March 22, 2013

First Posted

January 30, 2014

Study Start

May 1, 2013

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

March 27, 2014

Record last verified: 2014-03

Locations

US(1)