Nitrous Oxide Sedation: How Long Must People Really Avoid Their Normal Activities
| ISRCTN | ISRCTN88442975 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88442975 |
| Protocol serial number | 8098 |
| Sponsor | The University of Chicago (USA) |
| Funder | 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 |
- Submission date
- 10/05/2004
- Registration date
- 11/05/2004
- Last edited
- 31/08/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Lance Lichtor
Scientific
Scientific
Department of Anesthesia
200 Hawkins Drive, 6 JCP
Iowa City, IA
52242
United States of America
| lance-lichtor@uiowa.edu |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | Nitrous Oxide Sedation |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Provided by University Institutional Review Board. |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Nitrous Oxide |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/06/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 12 |
| Key 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. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/2003 |
| Date of final enrolment | 30/06/2003 |
Locations
Countries of recruitment
- United States of America
Study participating centre
Department of Anesthesia
Iowa City, IA
52242
United States of America
52242
United States of America
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 12/05/2004 | Yes | No |
