Comparing two analgesics, methoxyflurane and fentanyl, in an experimental model of hypovolemia in healthy volunteers

Methoxyflurane and fentanyl in hypovolemia induced by lower body negative pressure in healthy volunteers; A randomized, placebo-controlled crossover study - Methoxyflurane and fentanyl in lower body negative pressure

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-004144-29-NO

Enrollment

Registered

2020-03-19

Start date

2020-06-24

Completion date

Unknown

Last updated

2022-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The study will investigate and compare the responses to experimental hypovolemia of methoxyflurane, fentanyl and placebo (NaCl) using the "lower body negative pressure" (LBNP)-model .

Interventions

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Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age 18-64 years. 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 15 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Any medical condition limiting physical excertional capacity or requiring regular medication (allergy and contraceptives excepted) - Chronic pain - 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 - Substance abuse - Allergy or known serious side-effects to opioids or methoxyflurane - Use of pain medication or complementary medicine the last 2 days before a session - Use of alcohol last 24 h before each of the three experiments

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective of the trial is to study if and how the hemodynamic effects of experimental hypovolemia are affected by methoxyflurane and fentanyl compared to placebo. The primary outcome is cardiac stroke volume, and the main secondary outcome is time to time to termination of hypovolemic exposure. ;Secondary Objective: The secondary objectives of the trial will be exploratory analyses of physiological/ hemodynamic responses to hypovolemia during exposure to fentanyl or methoxyflurane; mean arterial pressure, arterial oxygen saturation, ECG, cerebral oxygen saturation, acral (finger) skin blood flow, peripheral venous pressure, respiratory frequency and end-tidal CO2 ;Primary end point(s): Primary end point: - Cardiac output during lower body negative pressure (LBNP). ;Timepoint(s) of evaluation of this end point: During experiments.	—

Measure

Time frame

Main Objective: The objective of the trial is to study if and how the hemodynamic effects of experimental hypovolemia are affected by methoxyflurane and fentanyl compared to placebo. The primary outcome is cardiac stroke volume, and the main secondary outcome is time to time to termination of hypovolemic exposure. ;Secondary Objective: The secondary objectives of the trial will be exploratory analyses of physiological/ hemodynamic responses to hypovolemia during exposure to fentanyl or methoxyflurane; mean arterial pressure, arterial oxygen saturation, ECG, cerebral oxygen saturation, acral (finger) skin blood flow, peripheral venous pressure, respiratory frequency and end-tidal CO2 ;Primary end point(s): Primary end point: - Cardiac output during lower body negative pressure (LBNP). ;Timepoint(s) of evaluation of this end point: During experiments.

—

Secondary

Measure	Time frame
Secondary end point(s): Secondary end points: - Time to end LBNP-exposure (hemodynamic decompensation) - Mean arterial pressure during LBNP. - Stroke volume during LBNP. ;Timepoint(s) of evaluation of this end point: During experiment.	—

Countries

Norway

Contacts

Public ContactDepartment of Anesthesiology

Oslo University Hospital

+4722119690

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026