Sevoflurane vs Nitrous Oxide Inhalation at Subanesthetic Concentrations - 11
3 other identifiers
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 1996
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 1996
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 1997
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 1997
CompletedFirst Submitted
Initial submission to the registry
September 20, 1999
CompletedFirst Posted
Study publicly available on registry
September 21, 1999
CompletedMay 28, 2015
May 1, 2015
1.3 years
September 20, 1999
May 26, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Pain intensity
Subjects underwent a 3 min cold immersion test at 30 min of inhalation and then provided response to pain intensity questionnaire
30 min of inhalation
Psychomotor performance
Subjects underwent psychomotor testing at baseline, during inhalation, and during recovery post inhalation
Baseline, 5 min of inhalation; 5, 30, 60 minutes recovery
Cognitive performance
Subject underwent memory, sedation, visual analog, and drug effects testing
Baseline, every 5 min during inhalation, 5, 30, & 60 min during recovery
Study Arms (5)
Placebo
PLACEBO COMPARATORSubject inhales no drug (100% oxygen)
0.3% sevoflurane
ACTIVE COMPARATOR0.6% sevoflurane
ACTIVE COMPARATOR15% Nitrous oxide
ACTIVE COMPARATOR30% Nitrous oxide
ACTIVE COMPARATORInterventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- University of Chicagolead
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (1)
University of Chicago, Anesthesia & Critical Care
Chicago, Illinois, 60637, United States
Related Publications (1)
Anesthesiology. 1997 (in press).
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James Zacny, Ph.D.
University of Chicago
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 1999
First Posted
September 21, 1999
Study Start
August 1, 1996
Primary Completion
November 1, 1997
Study Completion
November 1, 1997
Last Updated
May 28, 2015
Record last verified: 2015-05