Anesthetic, Inhalation, Electroencephalography, Nitrous Oxide
Conditions
Keywords
EEG, Slow wave activity, Nitrous oxide, N-methyl-D-aspartate-receptor blockade, Delta wave, Self-reported psychiatric symptoms
Brief summary
Our recent preclinical observations suggest that monitoring of slow electroencephalogram (EEG) oscillations may be used to predict the efficacy of rapid-acting antidepressants such as ketamine or nitrous oxide. In this project we will carry out critical clinical research on healthy volunteers and study the effects of nitrous oxide on EEG. Results will be used for the design of clinical trials on depressed individuals. The project will be done in collaboration between neuroscientists at the University of Helsinki and clinicians at the Tampere University Hospital.
Interventions
DRUGNitrous Oxide
50% nitrous oxide
Sponsors
Tampere University
University of Helsinki
Tampere University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
1. informed consent obtained 2. age between 18 - 40 3. male 4. body mass index 18 - 27
Exclusion criteria
1. Age \< 18 or \> 40 2. Alcohol Use Disorders Identification Test (AUDIT) \>6 points 3. Drug Abuse Screening Test 20 (DAST-20) \> 0 points 4. Beck Depression Inventory (BDI) \> 11 points 5. Symptom Check List 90 (SCL-90) over mean values of Finnish population in any dimensions of the SCL-90 or the global severity index 6. Any respiratory disorder including sleep apnea 7. Any heart illness 8. Epilepsy 9. Known vitamin B12 deficiency
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Slow wave activity | During nitrous oxide administration | Delta wave in EEG |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported psychiatric symptoms | Baseline, 20 minutes after nitrous oxide | Symptom Check List 90 (SCL-90) is a self-reported questionnaire measuring psychological stress. Results are normed, meaning that test scores can be compared to Finnish reference values. In this study we measure if there is an increase in self-reported psychiatric symptoms after nitrous oxide administration. |
| Side effects - anxiety | Baseline, 20 minutes after nitrous oxide | Self reported anxiety on a 0 (no at all) to 5 (very much) scale |
| Side effects - restlessness | Baseline, 20 minutes after nitrous oxide | Self reported restlessness on a 0 (no at all) to 5 (very much) scale |
| Side effects - mood elevation | Baseline, 20 minutes after nitrous oxide | Self reported mood elevation on a 0 (no at all) to 5 (very much) scale |
| Side effects - nausea | Baseline, 20 minutes after nitrous oxide | Self reported nausea on a 0 (no at all) to 5 (very much) scale |
| Side effects - agitation | Baseline, 20 minutes after nitrous oxide | Self reported agitation on a 0 (no at all) to 5 (very much) scale |
| Side effects - uneasiness | Baseline, 20 minutes after nitrous oxide | Self reported uneasiness on a 0 (no at all) to 5 (very much) scale |
| Side effects - tiredness | Baseline, 20 minutes after nitrous oxide | Self reported tiredness on a 0 (no at all) to 5 (very much) scale |
| Side effects - numbness | Baseline, 20 minutes after nitrous oxide | Self reported numbness on a 0 (no at all) to 5 (very much) scale |
| Side effects - dizziness | Baseline, 20 minutes after nitrous oxide | Self reported dizziness on a 0 (no at all) to 5 (very much) scale |
| Side effects - tension | Baseline, 20 minutes after nitrous oxide | Self reported tension on a 0 (no at all) to 5 (very much) scale |
Countries
Finland
Outcome results
None listed