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Sevoflurane vs Nitrous Oxide Inhalation at Subanesthetic Concentrations - 11

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ClinicalTrials.gov Identifier: NCT00000259
Recruitment Status : Completed
First Posted : September 21, 1999
Last Update Posted : May 28, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to conduct experiments to examine subjective and reinforcing effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug abusers and preference procedures will be used to assess reinforcing effects. Comparisons between nitrous oxide, opiates, and benzodiazepine antagonists will be made. To examine sevoflurane versus isoflurane inhalation at subanesthetic concentrations on mood, pain, and psychomotor performance.

Condition or disease Intervention/treatment
Opioid-Related Disorders Substance-Related Disorders Drug: 15 % Nitrous oxide Drug: 0.3 % Sevoflurane Drug: 30% Nitrous oxide Drug: 0.6% Sevoflurane Other: Placebo

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Official Title: Sevoflurane vs Nitrous Oxide Inhalation at Subanesthetic Concentrations
Study Start Date : August 1996
Primary Completion Date : November 1997
Study Completion Date : November 1997

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: Placebo
Subject inhales no drug (100% oxygen)
Other: Placebo
Active Comparator: 0.3% sevoflurane Drug: 0.3 % Sevoflurane
Active Comparator: 0.6% sevoflurane Drug: 0.6% Sevoflurane
Active Comparator: 15% Nitrous oxide Drug: 15 % Nitrous oxide
Active Comparator: 30% Nitrous oxide Drug: 30% Nitrous oxide

Outcome Measures

Primary Outcome Measures :
  1. Pain intensity [ Time Frame: 30 min of inhalation ]
    Subjects underwent a 3 min cold immersion test at 30 min of inhalation and then provided response to pain intensity questionnaire

  2. Psychomotor performance [ Time Frame: Baseline, 5 min of inhalation; 5, 30, 60 minutes recovery ]
    Subjects underwent psychomotor testing at baseline, during inhalation, and during recovery post inhalation

  3. Cognitive performance [ Time Frame: Baseline, every 5 min during inhalation, 5, 30, & 60 min during recovery ]
    Subject underwent memory, sedation, visual analog, and drug effects testing

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 39 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000259

United States, Illinois
University of Chicago, Anesthesia & Critical Care
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
National Institute on Drug Abuse (NIDA)
Principal Investigator: James Zacny, Ph.D. University of Chicago
More Information

Anesthesiology. 1997 (in press).

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00000259     History of Changes
Other Study ID Numbers: NIDA-08391-11
R01DA008391 ( U.S. NIH Grant/Contract )
First Posted: September 21, 1999    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: May 2015

Keywords provided by University of Chicago:
nitrous oxide
subjective effects
healthy volunteer

Additional relevant MeSH terms:
Substance-Related Disorders
Opioid-Related Disorders
Pathologic Processes
Chemically-Induced Disorders
Mental Disorders
Nitrous Oxide
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents