Effects of Combined Sevoflurane and Nitrous Oxide Inhalation - 14

May 26, 2015 updated by: University of Chicago

Effects of Combined Sevoflurane and Nitrous Oxide Inhalation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

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

  • United States
    • 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo +/- 30% Nitrous oxide
Other: Placebo
Drug: 30% Nitrous oxide
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity, pain bothersomeness
Time Frame: During inhalation
Inhalation was for 68 min divided into 4 blocks with nitrous oxide added during either block 2 or block 4
During inhalation
Mood
Time Frame: During inhalation
Inhalation was for 68 min divided into 4 blocks with nitrous oxide added during either block 2 or block 4
During inhalation
Psychomotor performance
Time Frame: During inhalation
Inhalation was for 68 min divided into 4 blocks with nitrous oxide added during either block 2 or block 4
During inhalation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Collaborators

National Institute on Drug Abuse (NIDA)

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

November 1, 1996

Primary Completion (Actual)

February 1, 1999

Study Completion (Actual)

February 1, 1999

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 27, 2015

Last Update Submitted That Met QC Criteria

May 26, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDA-08391-14
  • R01DA008391 (U.S. NIH Grant/Contract)
  • R01-08391-14

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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