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Sevoflurane vs Nitrous Oxide Inhalation at Subanesthetic Concentrations - 11

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000259
First Posted: September 21, 1999
Last Update Posted: May 28, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Chicago
  Purpose
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 Intervention
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 Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Official Title: Sevoflurane vs Nitrous Oxide Inhalation at Subanesthetic Concentrations

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • 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

  • 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

  • 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


Enrollment: 12
Study Start Date: August 1996
Study Completion Date: November 1997
Primary Completion Date: November 1997 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
Criteria
Please contact site for information.
  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


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
  More Information

Publications:
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 )
R01-08391-11
First Submitted: September 20, 1999
First Posted: September 21, 1999
Last Update Posted: May 28, 2015
Last Verified: May 2015

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

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