Effects of Combined Sevoflurane and Nitrous Oxide Inhalation - 14

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00000262
First received: September 20, 1999
Last updated: July 23, 2013
Last verified: July 2013
  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

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
Investigators
Principal Investigator: James Zacny, Ph.D. University of Chicago
  More Information

No publications provided

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: July 23, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Disease
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Pathologic Processes
Nitrous Oxide
Sevoflurane
Analgesics
Analgesics, Non-Narcotic
Anesthetics
Anesthetics, General
Anesthetics, Inhalation
Central Nervous System Agents
Central Nervous System Depressants
Hematologic Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014