Back to resultsEffects of Combined Sevoflurane and Nitrous Oxide Inhalation - 14
Primary Purpose
Opioid-Related Disorders, Substance-Related Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
30% Nitrous oxide
0.4% Sevoflurane
0.2% sevoflurane
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Opioid-Related Disorders focused on measuring nitrous oxide, sevoflurane, drug interaction, subjective effects, analgesia, healthy volunteers
Eligibility Criteria
Please contact site for information.
Sites / Locations
- University of Chicago, Anesthesia & Critical Care
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
Placebo +/- 30% Nitrous oxide
Sevoflurane 0.2% +/- 30% Nitrous oxide
Sevoflurane 0.4% +/- 30% Nitrous oxide
Arm Description
Outcomes
Primary Outcome Measures
Pain intensity, pain bothersomeness
Inhalation was for 68 min divided into 4 blocks with nitrous oxide added during either block 2 or block 4
Mood
Inhalation was for 68 min divided into 4 blocks with nitrous oxide added during either block 2 or block 4
Psychomotor performance
Inhalation was for 68 min divided into 4 blocks with nitrous oxide added during either block 2 or block 4
Secondary Outcome Measures
Full Information
NCT ID
NCT00000262
First Posted
September 20, 1999
Last Updated
May 26, 2015
Sponsor
University of Chicago
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00000262
Brief Title
Effects of Combined Sevoflurane and Nitrous Oxide Inhalation - 14
Official Title
Effects of Combined Sevoflurane and Nitrous Oxide Inhalation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
November 1996 (undefined)
Primary Completion Date
February 1999 (Actual)
Study Completion Date
February 1999 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine the effects of combined sevoflurane and nitrous oxide inhalation on mood, psychomotor performance, and the pain response in humans.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-Related Disorders, Substance-Related Disorders
Keywords
nitrous oxide, sevoflurane, drug interaction, subjective effects, analgesia, healthy volunteers
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo +/- 30% Nitrous oxide
Arm Type
Placebo Comparator
Arm Title
Sevoflurane 0.2% +/- 30% Nitrous oxide
Arm Type
Active Comparator
Arm Title
Sevoflurane 0.4% +/- 30% Nitrous oxide
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
30% Nitrous oxide
Intervention Type
Drug
Intervention Name(s)
0.4% Sevoflurane
Intervention Type
Drug
Intervention Name(s)
0.2% sevoflurane
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Pain intensity, pain bothersomeness
Description
Inhalation was for 68 min divided into 4 blocks with nitrous oxide added during either block 2 or block 4
Time Frame
During inhalation
Title
Mood
Description
Inhalation was for 68 min divided into 4 blocks with nitrous oxide added during either block 2 or block 4
Time Frame
During inhalation
Title
Psychomotor performance
Description
Inhalation was for 68 min divided into 4 blocks with nitrous oxide added during either block 2 or block 4
Time Frame
During inhalation
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Please contact site for information.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Zacny, Ph.D.
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago, Anesthesia & Critical Care
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
12. IPD Sharing Statement
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Effects of Combined Sevoflurane and Nitrous Oxide Inhalation - 14
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