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Sevoflurane vs Nitrous Oxide Inhalation at Subanesthetic Concentrations - 11

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00000259
First received: September 20, 1999
Last updated: May 26, 2015
Last verified: May 2015
  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 Blind (Subject, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   21 Years to 39 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
Please contact site for information.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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  R01-08391-11 
Study First Received: September 20, 1999
Last Updated: May 26, 2015
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on September 30, 2016