Nitrous oxide and cerebral vasodilatation: a dose-response study in healthy volunteers

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-007094-23-GB

Enrollment

Registered

2008-02-01

Start date

2008-10-09

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The study will be conducted in healthy volunteers. I will evaluate the effects of inhaled concentrations of nitrous oxide, ranging from 0% to 50%, on cerebral blood flow and cerebral vascular tone in a dose related manner.

Interventions

Trade Name: Medical nitrous oxide Pharmaceutical Form: Inhalation gas INN or Proposed INN: NITROUS OXIDE CAS Number: 10024972 Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Healthy volunteers aged between 18 and 50 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • History or evidence of a systemic illness or vascular disease • On prescription medication which may affect cardiovascular system • Any evidence of neurological disorder • Previous neurological surgery • Smokers • Pregnant or lactating females

Design outcomes

Primary

Measure	Time frame
Main Objective: Main objective of this trial is to construct a dose-response curve of nitrous oxide in < 50% concentration vs. effects on cerebral blood flow velocity and cerebral vascular tone.;Secondary Objective: Our overall objective is explore the potential of using nitrous oxide inhalation at concentrations < 50% in managment of cerebral vasospasm.; Primary end point(s): This is a dose response study. Cerebral blood flow velocity and haemodynamic parameters will be measured with subjects breathing nitrous oxide at 10%, 20%, 30%, 40% and 50%. Primary outcome variables 1. Middle cerebral artery (MCA) blood flow velocity (in relation to changes in inspired concentration of nitrous oxide) 2. Zero flow pressure (in relation to changes in inspired concentration of nitrous oxide) Secondary outcome variables Heart rate, blood pressure, cardiac output, stroke volume, central arterial compliance, systemic vascular resistance	—

Measure

Time frame

Main Objective: Main objective of this trial is to construct a dose-response curve of nitrous oxide in < 50% concentration vs. effects on cerebral blood flow velocity and cerebral vascular tone.;Secondary Objective: Our overall objective is explore the potential of using nitrous oxide inhalation at concentrations < 50% in managment of cerebral vasospasm.; Primary end point(s): This is a dose response study. Cerebral blood flow velocity and haemodynamic parameters will be measured with subjects breathing nitrous oxide at 10%, 20%, 30%, 40% and 50%. Primary outcome variables 1. Middle cerebral artery (MCA) blood flow velocity (in relation to changes in inspired concentration of nitrous oxide) 2. Zero flow pressure (in relation to changes in inspired concentration of nitrous oxide) Secondary outcome variables Heart rate, blood pressure, cardiac output, stroke volume, central arterial compliance, systemic vascular resistance

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026