Phase 4
Completed N=21
Network-Level Effects of Nitrous Oxide in the Human Brain
Healthy
Source: ClinicalTrials.gov NCT03435055 ↗
Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcomePrimary: Functional Connectivity During Nitrous Oxide — 0.1123; 0.0358; 0.1492; 0.0394 Fisher's r transformed z score — p=0.001
◆ Published Evidence
Established
48citations · ~16 / year
Classical and non-classical psychedelic drugs induce common network changes in human cortex.
Summary
The purpose of this study is to understand how a commonly used drug, nitrous oxide, acts on the brain to reduce pain. Nitrous oxide is commonly used in anesthesiology but there is limited knowledge on how this drug affects functional networks in the brain.
Linked Publications
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Classical and non-classical psychedelic drugs induce common network changes in human cortex.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Functional Connectivity During Nitrous Oxide |
0.1123; 0.0358; 0.1492; 0.0394 | 0.001 sig |
| PRIMARY Functional Connectivity Associated With Tonic Stimulus |
-0.0509; 0.0486 | 0.006 sig |
| SECONDARY Tonic Stimulus Intensity During Nitrous Oxide |
4.9688; 2.500 | <0.01 sig |
| SECONDARY Spectral Power of Sub-anesthetic Dose of Nitrous Oxide |
13.31; 14.65; 11.88; 12.80; 6.72; 6.97 | 0.0622 |
Eligibility Criteria
Inclusion Criteria
- Body mass index <30
- Must be right-handed
- Must be capable of giving written informed consent
Exclusion Criteria
- History of obstructive sleep apnea;
- History of a difficult airway with a previous anesthetic
- Gastroesophageal reflux;
- Hypertension or other cardiovascular abnormalities;
- Pulmonary hypertension;
- History of recreational drug use;
- History of chronic alcohol abuse
- Having any chronic medical illness involving pain;
- History of major depression;
- History of psychosis or bipolar disorder;
- History of methylenetetrahydrofolate reductase deficiency;
- History of a known hypersensitivity to ketamine, midazolam, Zofran, labetalol or glycopyrrolate
- History of seizures or other neurologic disorders;
- Pregnant or nursing mothers;
- Tattoos on the head or neck region - all other tattoos are subject to determination by investigators;
- Contraindications to neuroimaging methods;
- Any impairment, activity or situation that in the judgment of the Study Coordinator or Principal Investigators would prevent satisfactory completion of the study protocol.
Data sourced from ClinicalTrials.gov (NCT03435055) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.