Effect of Nitrous Oxide on EEG (HUMANOID)

Tampere University Hospital

Status and phase: Completed; Phase 1

Conditions: Electroencephalography; Anesthetic, Inhalation; Nitrous Oxide

Treatments: Drug: Nitrous Oxide

Study type: Interventional

Funder types: Other

Identifiers

NCT04884893

R18097M

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Intermittent nitrous oxide

Experimental group

Description:

10 minutes of 50% nitrous oxide + 10 min 100% oxygen + 10 min 50% nitrous oxide + 10 min 100% oxygen

Treatment:

Drug: Nitrous Oxide

Continuous nitrous oxide

Experimental group

Description:

20 min 50% nitrous oxide + 20 min 100% oxygen

Treatment:

Drug: Nitrous Oxide