NCT00000262

Brief Summary

The purpose of this study is to determine the effects of combined sevoflurane and nitrous oxide inhalation on mood, psychomotor performance, and the pain response in humans.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 1996

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1996

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 1999

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 1999

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 20, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 21, 1999

Completed
Last Updated

May 27, 2015

Status Verified

May 1, 2015

Enrollment Period

2.3 years

First QC Date

September 20, 1999

Last Update Submit

May 26, 2015

Conditions

Opioid-Related DisordersSubstance-Related Disorders

Keywords

nitrous oxidesevofluranedrug interactionsubjective effectsanalgesiahealthy volunteers

Outcome Measures

Primary Outcomes (3)

  • Pain intensity, pain bothersomeness

    Inhalation was for 68 min divided into 4 blocks with nitrous oxide added during either block 2 or block 4

    During inhalation

  • Mood

    Inhalation was for 68 min divided into 4 blocks with nitrous oxide added during either block 2 or block 4

    During inhalation

  • Psychomotor performance

    Inhalation was for 68 min divided into 4 blocks with nitrous oxide added during either block 2 or block 4

    During inhalation

Study Arms (3)

Placebo +/- 30% Nitrous oxide

PLACEBO COMPARATOR
Drug: 30% Nitrous oxideOther: Placebo

Sevoflurane 0.2% +/- 30% Nitrous oxide

ACTIVE COMPARATOR
Drug: 30% Nitrous oxideDrug: 0.2% sevoflurane

Sevoflurane 0.4% +/- 30% Nitrous oxide

ACTIVE COMPARATOR
Drug: 30% Nitrous oxideDrug: 0.4% Sevoflurane

Interventions

30% Nitrous oxideDRUG
Placebo +/- 30% Nitrous oxideSevoflurane 0.2% +/- 30% Nitrous oxideSevoflurane 0.4% +/- 30% Nitrous oxide
0.4% SevofluraneDRUG
Sevoflurane 0.4% +/- 30% Nitrous oxide
0.2% sevofluraneDRUG
Sevoflurane 0.2% +/- 30% Nitrous oxide
PlaceboOTHER
Placebo +/- 30% Nitrous oxide

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Please contact site for information.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Chicago, Anesthesia & Critical Care

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Opioid-Related DisordersSubstance-Related DisordersAgnosia

Interventions

Nitrous OxideSevoflurane

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersChemically-Induced DisordersMental DisordersPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nitrogen OxidesGasesInorganic ChemicalsNitrogen CompoundsOxidesOxygen CompoundsMethyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbons

Study Officials

  • James Zacny, Ph.D.

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 1999

First Posted

September 21, 1999

Study Start

November 1, 1996

Primary Completion

February 1, 1999

Study Completion

February 1, 1999

Last Updated

May 27, 2015

Record last verified: 2015-05

Locations

US(1)