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Effects of Combined Sevoflurane and Nitrous Oxide Inhalation - 14

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ClinicalTrials.gov Identifier: NCT00000262
Recruitment Status : Completed
First Posted : September 21, 1999
Last Update Posted : May 27, 2015
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Chicago

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.

Condition or disease Intervention/treatment Phase
Opioid-Related Disorders Substance-Related Disorders Drug: 30% Nitrous oxide Drug: 0.4% Sevoflurane Drug: 0.2% sevoflurane Other: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Effects of Combined Sevoflurane and Nitrous Oxide Inhalation
Study Start Date : November 1996
Actual Primary Completion Date : February 1999
Actual Study Completion Date : February 1999

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo +/- 30% Nitrous oxide Drug: 30% Nitrous oxide Other: Placebo
Active Comparator: Sevoflurane 0.2% +/- 30% Nitrous oxide Drug: 30% Nitrous oxide Drug: 0.2% sevoflurane
Active Comparator: Sevoflurane 0.4% +/- 30% Nitrous oxide Drug: 30% Nitrous oxide Drug: 0.4% Sevoflurane



Primary Outcome Measures :
  1. Pain intensity, pain bothersomeness [ Time Frame: During inhalation ]
    Inhalation was for 68 min divided into 4 blocks with nitrous oxide added during either block 2 or block 4

  2. Mood [ Time Frame: During inhalation ]
    Inhalation was for 68 min divided into 4 blocks with nitrous oxide added during either block 2 or block 4

  3. Psychomotor performance [ Time Frame: During inhalation ]
    Inhalation was for 68 min divided into 4 blocks with nitrous oxide added during either block 2 or block 4



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
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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): NCT00000262


Locations
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)
Investigators
Principal Investigator: James Zacny, Ph.D. University of Chicago

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00000262     History of Changes
Other Study ID Numbers: NIDA-08391-14
R01DA008391 ( U.S. NIH Grant/Contract )
R01-08391-14
First Posted: September 21, 1999    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: May 2015

Keywords provided by University of Chicago:
nitrous oxide
sevoflurane
drug interaction
subjective effects
analgesia
healthy volunteers

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