Condition category
Surgery
Date applied
10/05/2004
Date assigned
11/05/2004
Last edited
31/08/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Lance Lichtor

ORCID ID

Contact details

Department of Anesthesia
200 Hawkins Drive
6 JCP
Iowa City
IA
52242
United States of America
lance-lichtor@uiowa.edu

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

8098

Study information

Scientific title

Acronym

Nitrous Oxide Sedation

Study hypothesis

Not provided at time of registration

Ethics approval

Provided by University Institutional Review Board.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Sedation

Intervention

On three separate occasions, volunteers (N=12) received 100% oxygen or 20% or 40% N2O for 30 min. Dependent measures included the multiple sleep latency test (MSLT), a Drug Effects/Liking questionnaire, visual analogue scales, and five psychomotor tests.

Intervention type

Drug

Phase

Not Specified

Drug names

Nitrous Oxide

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2003

Overall trial end date

30/06/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Candidates who stated they were healthy, non-smoking, age 21-35 years, within 30% of ideal body weight and had normal sleeping habits were scheduled for a screening interview. Urine pregnancy tests were performed to ensure that female subjects were not pregnant. Subjects were asked to avoid depressants including ethanol (confirmed by measuring exhaled ethanol) and stimulants for 24 hours before study sessions. Subjects were formally admitted to the study if, after sleep latency testing, their average sleep latency was 10 min and they had no onsets of rapid eye movement (REM) sleep, which is indicative of narcolepsy.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

12

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/2003

Recruitment end date

30/06/2003

Locations

Countries of recruitment

United States of America

Trial participating centre

Department of Anesthesia
Iowa City, IA
52242
United States of America

Sponsor information

Organisation

The University of Chicago (USA)

Sponsor details

Department of Anesthesia
5841 S. Maryland Avenue
Chicago
IL
60637
United States of America
lance-lichtor@uiowa.edu

Sponsor type

University/education

Website

http://www.uchicago.edu/

Funders

Funder type

Research organisation

Funder name

NIH (GCRC at the University of Chicago, funded by grant number M01 RR00055 from the National Center for Research Resources of the National Institutes of Health) and the Department of Anesthesia, University of Chicago

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15140266

Publication citations

  1. Results

    Lichtor JL, Lane BS, Zimmerman MB, Residual sleepiness after N2O sedation: a randomized control trial [ISRCTN88442975]., BMC Anesthesiol, 2004, 4, 1, 5, doi: 10.1186/1471-2253-4-5.

Additional files

Editorial Notes