This is part of a series of studies investigating the potential therapeutic use of low dose nitrous oxide in the treatment of cerebral vasospasm, a condition which occurs following brain injury and stroke. The aim is to compare the effects of 30% nitrous oxide with therapeutic dose of nimodipine (the current treatment for cerebral vasospasm) on cerebral vascular physiology and systemic vascular effects.
Conditions
Interventions
Trade Name: Medical Nitrous Oxide
Product Name: Nitrous Oxide
Pharmaceutical Form: Inhalation vapour*
Trade Name: Nimotop
Product Name: Nimotop
Pharmaceutical Form: Tablet
Sponsors
University of Nottingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: Males and Females aged between 18 and 50 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: People with history or evidence of cardiac or vascular disease. Systemic illness. Known hypersensitivity to nimodipine People with evidence of a neurological disorder People with liver disease Smokers Pregnant or lactating females Pneumothorax or emphysema. People having received recent intraocular injection of gas (such as SF6). Middle ear conditions. People on the following prescription medication: Antihypertensives, Antiepileptics, Rifampicin, Macrolide antibiotics, Anti-HIV medication, Azole antimycotics, Antidepressants, Cimetidine. Volunteers who are found to have evidence of carotid artery disease by Duplex scan screening will not take part in the study. In females pregnancy will be excluded by an hCG test within 24 hours preceding MRI scan.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Principle objective: To compare the effects of 30% nitrous oxide (low dose laughing gas) with the therapeutic dose of nimodipine. Nimodipine is the drug currently given to people who have suffered a type of brain haemorrhage called a 'sub-arachnoid haemorrhage'. It is given to increase blood supply to injured areas, increasing the availability of oxygen and nutrients. We want to compare brain blood flow physiology: the ability of the blood vessels to regulate the blood flowing through them; the amount of blood flowing through the blood vessels. ;Secondary Objective: We also want to compare the effects the two interventions have on: the ability of the brain to regulate its own blood flow (called autoregulation); blood pressure; pulse rate (number of heart beats per minute); the amount of blood flowing through the heart in one minute, and the dilatation of the blood vessels in the patients extremeties (which causes flushing). ;Primary end point(s): Primary outcome measures: Primary Outcomes Transcranial Doppler Variable: The difference in maximum change from baseline in middle cerebral artery (MCA) flow velocity (indicating changes in cerebral blood flow) between the two intervention arms. Comparing values obtained for 30% nitrous oxide and 60mg nimodipine oral ingestion. | — |
Countries
United Kingdom
Outcome results
None listed