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

Phase 1

Active, not recruiting

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 .
Therapeutic area: Body processes [G] - Physiological processes [G07]

Registration Number: EUCTR2019-004144-29-NO

Lead Sponsor: Oslo University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Recruiting

Sex: All

Target Recruitment: 15

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>;Primary end point(s): Primary end point: <br>- Cardiac output during lower body negative pressure (LBNP). ;Timepoint(s) of evaluation of this end point: During experiments.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary end points: <br>- Time to end LBNP-exposure (hemodynamic decompensation)<br>- Mean arterial pressure during LBNP. <br>- Stroke volume during LBNP. ;Timepoint(s) of evaluation of this end point: During experiment.