- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00000254
Isoflurane at Subanesthetic Concentrations - 6
May 26, 2015 updated by: University of Chicago
Isoflurane at Subanesthetic Concentrations
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 test the hypothesis that isoflurane at subanesthetic concentrations does not reduce cold-water immersion pain in healthy volunteers.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60637
- University of Chicago, Anesthesia & Critical Care
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 34 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Please contact site for information.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: 0% isoflurane
|
Used as pain assay positive control
0% isoflurane in oxygen
|
Active Comparator: 0.2% isoflurane
|
Used as pain assay positive control
|
Active Comparator: 0.4% isoflurane
|
Used as pain assay positive control
|
Active Comparator: 0.6% isoflurane
|
Used as pain assay positive control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain response
Time Frame: Post inhalation
|
Effects of inhaled isoflurane on pain from immersion of subject's arm in ice cold water.
Nitrous oxide (40%) was used as a positive control to confirm sensitivity of the pain assay.
|
Post inhalation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Anesthesiology, 1995, 83: A287
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 1995
Primary Completion (Actual)
September 1, 1995
Study Completion (Actual)
September 1, 1995
Study Registration Dates
First Submitted
September 20, 1999
First Submitted That Met QC Criteria
September 20, 1999
First Posted (Estimate)
September 21, 1999
Study Record Updates
Last Update Posted (Estimate)
May 28, 2015
Last Update Submitted That Met QC Criteria
May 26, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Pathologic Processes
- Narcotic-Related Disorders
- Substance-Related Disorders
- Disease
- Opioid-Related Disorders
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, General
- Anesthetics
- Analgesics, Non-Narcotic
- Anesthetics, Inhalation
- Nitrous Oxide
- Isoflurane
Other Study ID Numbers
- NIDA-08391-6
- R01DA008391 (U.S. NIH Grant/Contract)
- R01-08391-6
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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