Effects of Combined Sevoflurane and Nitrous Oxide Inhalation - 14

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00000262
First received: September 20, 1999
Last updated: May 26, 2015
Last verified: May 2015
  Purpose
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.

Condition Intervention
Opioid-Related Disorders
Substance-Related Disorders
Drug: 30% Nitrous oxide
Drug: 0.4% Sevoflurane
Drug: 0.2% sevoflurane
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Effects of Combined Sevoflurane and Nitrous Oxide Inhalation

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Pain intensity, pain bothersomeness [ Time Frame: During inhalation ] [ Designated as safety issue: No ]
    Inhalation was for 68 min divided into 4 blocks with nitrous oxide added during either block 2 or block 4

  • Mood [ Time Frame: During inhalation ] [ Designated as safety issue: No ]
    Inhalation was for 68 min divided into 4 blocks with nitrous oxide added during either block 2 or block 4

  • Psychomotor performance [ Time Frame: During inhalation ] [ Designated as safety issue: No ]
    Inhalation was for 68 min divided into 4 blocks with nitrous oxide added during either block 2 or block 4


Enrollment: 20
Study Start Date: November 1996
Study Completion Date: February 1999
Primary Completion Date: February 1999 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo +/- 30% Nitrous oxide Drug: 30% Nitrous oxide Other: Placebo
Active Comparator: Sevoflurane 0.2% +/- 30% Nitrous oxide Drug: 30% Nitrous oxide Drug: 0.2% sevoflurane
Active Comparator: Sevoflurane 0.4% +/- 30% Nitrous oxide Drug: 30% Nitrous oxide Drug: 0.4% Sevoflurane

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
Please contact site for information.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00000262

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

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00000262     History of Changes
Other Study ID Numbers: NIDA-08391-14  R01DA008391  R01-08391-14 
Study First Received: September 20, 1999
Last Updated: May 26, 2015
Health Authority: United States: Federal Government

Keywords provided by University of Chicago:
nitrous oxide
sevoflurane
drug interaction
subjective effects
analgesia
healthy volunteers

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 July 21, 2016