Completed

Sevoflurane vs Nitrous Oxide Inhalation at Subanesthetic Concentrations - 11

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

15 % Nitrous oxide

+ 0.3 % Sevoflurane
+ 30% Nitrous oxide
Drug
Other
Who is being recruted

Opioid-Related Disorders

+ Substance-Related Disorders
From 21 to 39 Years

See all eligibility criteria

How is the trial designed

Other Study

Placebo-Controlled
Interventional
Study Start: August 1996

See protocol details

Summary

Principal SponsorUniversity of Chicago
Last updated: May 28, 2015
Sourced from a government-validated database.Claim as a partner
Study start date: August 1, 1996Actual date on which the first participant was enrolled.

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. Comparisons between nitrous oxide, opiates, and benzodiazepine antagonists will be made. To examine sevoflurane versus isoflurane inhalation at subanesthetic concentrations on mood, pain, and psychomotor performance.

Official TitleSevoflurane vs Nitrous Oxide Inhalation at Subanesthetic Concentrations 
Principal SponsorUniversity of Chicago
Last updated: May 28, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
12 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.

How participants are assigned to different groups/arms
In this clinical study, participants are assigned to groups based on specific criteria, such as their medical history or a doctor's recommendation. This approach ensures that treatments are given to those who may benefit the most, based on known factors.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants receive different treatments one after the other, switching from one to another during the study. This helps researchers understand how individuals respond to multiple treatments.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.

Other Options
Non-placebo-controlled: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.

How the interventions assigned to participants is kept confidential
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 21 to 39 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Opioid-Related Disorders
Substance-Related Disorders
Criteria

Please contact site for information.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
5 intervention groups 

are designated in this study

20% chance 

of being blinded to the placebo group

Treatment Groups
Group I
Placebo
Subject inhales no drug (100% oxygen)
Group II
Active Comparator
Group III
Active Comparator
Group IV
Active Comparator
Group 5
Active Comparator
Study Objectives
Primary Objectives

Subjects underwent a 3 min cold immersion test at 30 min of inhalation and then provided response to pain intensity questionnaire

Subjects underwent psychomotor testing at baseline, during inhalation, and during recovery post inhalation

Subject underwent memory, sedation, visual analog, and drug effects testing

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
University of Chicago, Anesthesia & Critical CareChicago, United StatesSee the location
CompletedOne Study Center