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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04641949
Other study ID # lbnp_methoxy_fent_2019
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date November 18, 2020
Est. completion date March 8, 2022

Study information

Verified date June 2022
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

The study will explore the effects of fentanyl and methoxyflurane versus placebo (NaCl; saline) on the hemodynamic response to hypovolemia in healty volunteers. Hypovolemia will be induced in the "lower body negative pressure" model. XX healthy volunteers will be exposed to inhaled methoxyflurane, 3 ml or intravenous fentanyl, XX mg or placebo in a randomized order (cross-over) at least 3 days apart.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Lower body negative pressure (LBNP)
LBNP is a model of experimental hypovolemia, whereby the lower body is exposed to negative pressure leading to sequestering of blood in the lower body and central hypovolemia. LBNP will be induced stepwise with increments of 10 mmHg, each level lasting 1 min. LBNP will be terminated at symptoms or signs of impending hemodynamic collapse.

Locations

Country Name City State
Norway Oslo University Hospital Oslo

Sponsors (1)

Lead Sponsor Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

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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