Methoxyflurane and Fentanyl in LBNP

Phase 4CompletedNCT04641949

Oslo University Hospital15 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Hypovolemia Cardiac Output, Low Analgesia

Interventions

Lower body negative pressure (LBNP)PROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Oslo University Hospital

Oslo, Norway

Outcomes

Primary Outcomes

Cardiac output

Cardiac output as measured by suprasternal Doppler and/ or non-invasive (volume clamp) pulse contour analysis.

Time frame: Measured continuously during LBNP-exposure.

Secondary Outcomes

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

Time frame: 15 minutes

Mean arterial pressure

Change in mean arterial blood pressure with increasing LBNP, as measured by the volume-clamp method.

Time frame: Measured continuously during LBNP-exposure.

Stroke volume

Change in cardiac stroke volume with increasing LBNP, as measured by suprasternal Doppler and/ or the volume-clamp method.

Time frame: Measured continuously during LBNP-exposure.

Data from ClinicalTrials.gov

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