Effects of Subanesthetic Concentrations of Isoflurane/Nitrous Oxide - 3
3 other identifiers
interventional
10
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. To evaluate the acute and residual effects of subanesthetic concentrations of isoflurane/nitrous oxide combinations in healthy volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Apr 1994
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
April 1, 1994
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 1996
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 1996
CompletedFirst Submitted
Initial submission to the registry
September 20, 1999
CompletedFirst Posted
Study publicly available on registry
September 21, 1999
CompletedDecember 2, 2015
November 1, 2015
1.8 years
September 20, 1999
November 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Logical reasoning test
15 & 30 min inhalation and 5, 30, & 60 min post inhalation
Free recall memory test
15 & 30 min inhalation and 5, 30, & 60 min post inhalation
Auditory reaction time
15 & 30 min inhalation and 5,30 & 60 min post inhalation
Digit symbol substitution test
2,15 & 30 min inhalation and 5,30 & 60 min post inhalation
Study Arms (6)
Placebo
PLACEBO COMPARATORSubjects inhale 100% oxygen
30% N2O
ACTIVE COMPARATORSubjects inhale 30% N2O
0.2% isoflurane
ACTIVE COMPARATORSubjects inhale 0.2% isoflurane
0.4% isoflurane
ACTIVE COMPARATORSubjects inhale 0.4% isoflurane
0.2% isoflurane + 30% N2O
ACTIVE COMPARATORSubjects will inhale a combination of 0.2% isoflurane and 30% N2O
0.4% isoflurane + 30% N2O
ACTIVE COMPARATORSubjects will inhale a combination of 0.4% isoflurane and 30% N2O
Interventions
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 (2)
Zacny JP, Yajnik S, Lichtor JL, Klafta JM, Young CJ, Thapar P, Rupani G, Coalson DW, Apfelbaum JL. The acute and residual effects of subanesthetic concentrations of isoflurane/nitrous oxide combinations on cognitive and psychomotor performance in healthy volunteers. Anesth Analg. 1996 Jan;82(1):153-7. doi: 10.1097/00000539-199601000-00028.
PMID: 8712393BACKGROUNDWhelan J, Hackshaw A, McTiernan A, Grimer R, Spooner D, Bate J, Ranft A, Paulussen M, Juergens H, Craft A, Lewis I. Survival is influenced by approaches to local treatment of Ewing sarcoma within an international randomised controlled trial: analysis of EICESS-92. Clin Sarcoma Res. 2018 Mar 30;8:6. doi: 10.1186/s13569-018-0093-y. eCollection 2018.
PMID: 29610659DERIVED
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
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 1999
First Posted
September 21, 1999
Study Start
April 1, 1994
Primary Completion
January 1, 1996
Study Completion
January 1, 1996
Last Updated
December 2, 2015
Record last verified: 2015-11