Phase 4 N=21 Basic Science

Network-Level Effects of Nitrous Oxide in the Human Brain

Healthy

Bottom Line

View on ClinicalTrials.gov: NCT03435055 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2021

Primary outcome: Primary: Functional Connectivity During Nitrous Oxide — 0.1123; 0.0358; 0.1492; 0.0394 Fisher's r transformed z score — p=0.001

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Nitrous Oxide Gas for Inhalation (Drug)
Age: Adult · 21+ yrs
Sex: All
Sponsor: University of Michigan
Primary completion: Oct 2019

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

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03435055). 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.