Nitrous Oxide and Cerebral Autoregulation

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-004669-24-GB

Enrollment

Registered

2008-10-03

Start date

2009-01-02

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

This study is being conducted to evaluate the effects of inhaled concentrations of 20%, 30% and 40% Nitrous Oxide on cerebral autoregulation in healthy volunteers using transcranial doppler ultrasonography. This is part of a series of studies investigating the potential therapeutic use of low dose inhlaed nirous oxide in the treatment of cerebral vasospasm, ac condition which often occurs following traumatic brain in jury or stroke and can cause significant morbidity and mortality.

Interventions

Trade Name: Medical Nitrous Oxide Product Name: Nitrous Oxide Pharmaceutical Form: Inhalation gas INN or Proposed INN: NITROUS OXIDE CAS Number: 10024972 Concentration unit: % percent Concentration ty

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: age 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: those with history or evidence of systemic illness or vascular disease those taking prescription medication which may affect the cardiovascular system any evidence of neurological disorder smoker pregnant or lactating females

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the effects of inhaled nitrous oxide 20%, 30% and 40% on cerebral autoregulation.;Secondary Objective: To evaluate the effects of inhaled nitrous oxide 20%, 30% and 40% on cerebrovascular tone.;Primary end point(s): To discover the effect of inhalation of low dose Nitrous Oxide on cerebral autoregulation primary outcomes 1.Transient Hyperaemic Response ratio at 20,30,40% inspired concentration of nitrous oxide 2.Strength of autoregulation at the 20,30,40 % inspired concentration of nitrous oxide secondary outcomes Middle Cerebral Artery blood flow velocity ZFP (cerebral vascular tone) heart rate, blood pressure, cardiac output, stroke volume, systemic vascular resistance	—

Measure

Time frame

Main Objective: To evaluate the effects of inhaled nitrous oxide 20%, 30% and 40% on cerebral autoregulation.;Secondary Objective: To evaluate the effects of inhaled nitrous oxide 20%, 30% and 40% on cerebrovascular tone.;Primary end point(s): To discover the effect of inhalation of low dose Nitrous Oxide on cerebral autoregulation primary outcomes 1.Transient Hyperaemic Response ratio at 20,30,40% inspired concentration of nitrous oxide 2.Strength of autoregulation at the 20,30,40 % inspired concentration of nitrous oxide secondary outcomes Middle Cerebral Artery blood flow velocity ZFP (cerebral vascular tone) heart rate, blood pressure, cardiac output, stroke volume, 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