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Recruiting NCT07690358

Concentrations of Nitrous Oxide in Blood, Exhaled Air and Urine After Various Types of Exposure.

No phase Interventional Intoxication by Drug

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nitrous Oxide 99 %, Nitrous Oxide + Oxygen Gas.
Who it may be relevant to
Registry conditions: Intoxication by Drug. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Undersøgelse af Lattergaskoncentrationer i Blod, udåndingsluft og Urin Ved Forskellige Eksponeringer

Overview

The study examines the concentrations of nitrous oxide that are achieved in blood, exhaled air, and urine after three different exposures to nitrous oxide: inhalation of three or four cartridges of nitrous oxide released in a car cabin in a switched-off car, consumption of 100 g of whipped cream in which nitrous oxide is used as a propellant, and exposure through work as a midwife in a delivery room. The concentrations in blood and exhaled air are measured for up to 1 hour after exposure, and in urine for up to 2 hours after exposure. The concentrations in blood and urine are measued with gas chromatography and mass spectrometry, while the concentration in exhaled air is measured by a sensor using an NDIR sensor (Olythe, France).

Interventions

  • Other Nitrous Oxide 99 %
    Passive exposure to Nitrous Oxide
  • Other Nitrous Oxide + Oxygen Gas
    Midwifes are exposed through work in a delivery room

Primary outcome measures

  • Detection time of Nitrous Oxide in blood [Time frame: From end of exposure to 1 hour after end of exposure]

Eligibility criteria

For arm 1, 2, and 3:

Inclusion criteria

  • Age 18-65 years
  • Able to understand Danish
  • Willing to use effective contraception for 24 hours after the end of exposure (oral contraceptives, contraceptive implant, transdermal patch, vaginal ring, or injectable contraceptives)
  • Written informed consent

Exclusion criteria

  • Current or past abuse of drugs, nitrous oxide (N₂O), or alcohol
  • A psychiatric disorder requiring medical treatment, including severe depression
  • A diagnosis of epilepsy
  • Symptoms of peripheral neuropathy
  • Significant cardiac or pulmonary disease
  • Previous allergic or adverse reaction to N₂O
  • Diving within the past 2 days
  • Inability to refrain from diving for 2 days after the study
  • Occupational exposure to N₂O
  • Use of N₂O within the past 3 months
  • Treatment with methotrexate, benzodiazepines, opioids, or other centrally depressant drugs
  • Recent intraocular gas injection
  • Known impaired liver or kidney function
  • Pregnant or breastfeeding women (fertile women, defined as amenorrhea for less than 12 months, must have a negative hCG pregnancy test prior to receiving the study intervention)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

Denmark · 1 center
  • Department of Forensic Medicine — Aarhus

Identifiers

NCT: NCT07690358 · 1-10-72-156-25

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗