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Completed

NCT Number: NCT04641949

Methoxyflurane and Fentanyl in LBNP

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.

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Key information

Conditions

Hypovolemia Agnosia Analgesia Cardiac Output, Low Cardiovascular Diseases Heart Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Oslo University Hospital

Oslo, 0586, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Cardiac output

    Time frame: Measured continuously during LBNP-exposure.

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

Secondary outcomes

  1. Time to hemodynamic decompensation

    Time frame: 15 minutes

    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

  2. Mean arterial pressure

    Time frame: Measured continuously during LBNP-exposure.

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

  3. Stroke volume

    Time frame: Measured continuously during LBNP-exposure.

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

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

Methoxyflurane and Fentanyl in the Lower Body Negative Pressure Model of Hypovolemia in Healthy Volunteers; a Randomized, Placebo-controlled Crossover Study

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 24, 2020
Registry last updated
Jun 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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