Analgesia Clinical Trial
Official title:
Methoxyflurane and Fentanyl in the Lower Body Negative Pressure Model of Hypovolemia in Healthy Volunteers; a Randomized, Placebo-controlled Crossover Study
Verified date | June 2022 |
Source | Oslo University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study is a single-centre, placebo-controlled, crossover study on healthy volunteers aiming to explore non-inferiority of methoxyflurane and fentanyl compared to placebo on the tolerance to hypovolemia.
Status | Completed |
Enrollment | 15 |
Est. completion date | March 8, 2022 |
Est. primary completion date | March 8, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Must be at least 18 years of age. - Must be below 65 years of age. - Signed informed consent and expected cooperation for the study and follow up must be obtained and documented according to ICH GCP, and national/local regulations. Exclusion Criteria: - Any medical condition limiting physical excertional capacity or requiring regular medication (allergy and oral contraceptives excepted) - Pregnancy - History of syncope (syncope of presumed vasovagal nature with known precipitating factor excepted) - Any known cardiac arrhythmia - History of renal disease - History of liver disease - Previous substance abuse - Allery or known serious side-effects to opioids or methoxyflurane |
Country | Name | City | State |
---|---|---|---|
Norway | Oslo University Hospital | Oslo |
Lead Sponsor | Collaborator |
---|---|
Oslo University Hospital |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cardiac output | Cardiac output as measured by suprasternal Doppler and/ or non-invasive (volume clamp) pulse contour analysis. | Measured continuously during LBNP-exposure. | |
Secondary | Time to hemodynamic decompensation | Time from start LBNP to symtomps or signs of hemodynamic decompensation (and termination of LBNP); defined by:
Symptoms of pre-syncope (light-headedness, nausea or sweating) Mean arterial pressure-reduction to less than 75% of baseline for >3 s Heart rate-reduction to less than 75% baseline for >3 s |
15 minutes | |
Secondary | Mean arterial pressure | Change in mean arterial blood pressure with increasing LBNP, as measured by the volume-clamp method. | Measured continuously during LBNP-exposure. | |
Secondary | Stroke volume | Change in cardiac stroke volume with increasing LBNP, as measured by suprasternal Doppler and/ or the volume-clamp method. | Measured continuously during LBNP-exposure. |
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