Methoxyflurane and Fentanyl in LBNP

Phase 4

Completed

• Conditions: Analgesia; Hypovolemia; Cardiac Output, Low
• Interventions: Procedure: Lower body negative pressure (LBNP)

• Registration Number: NCT04641949
• Lead Sponsor: Oslo University Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2020-11-18
• Study First Submitted: 2020-11-18
• Study First Submitted QC: 2020-11-18
• Study First Posted: 2020-11-24
• Primary Completion: 2022-03-08
• Study Completion: 2022-03-08
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-28
• Last Update Posted: 2022-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Lower body negative pressure (LBNP)	Intravenous NaCl 9 mg/ml, XX ml, single dose. Inhalation NaCl 9 mg/ml, 3 ml, single dose.
Fentanyl	Lower body negative pressure (LBNP)	Intravenous fentanyl 50 microgr/ml, XX ml, single dose Inhalation NaCl 9 mg/ml, 3 ml, single dose.
Methoxyflurane	Lower body negative pressure (LBNP)	Inhalation methoxyflurane 99,9%, 3 ml, single dose. Intravenous NaCl 9 mg/ml, XX ml, single dose.

Primary Outcome Measures

Name	Time	Method
Cardiac output	Measured continuously during LBNP-exposure.	Cardiac output as measured by suprasternal Doppler and/ or non-invasive (volume clamp) pulse contour analysis.

Secondary Outcome Measures

Name	Time	Method
Time to hemodynamic decompensation	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
Mean arterial pressure	Measured continuously during LBNP-exposure.	Change in mean arterial blood pressure with increasing LBNP, as measured by the volume-clamp method.
Stroke volume	Measured continuously during LBNP-exposure.	Change in cardiac stroke volume with increasing LBNP, as measured by suprasternal Doppler and/ or the volume-clamp method.

Trial Locations

Locations (1)

Oslo University Hospital; 🇳🇴 Oslo, Norway