Methoxyflurane and Fentanyl in LBNP

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04641949
• Other study ID #: lbnp_methoxy_fent_2019
• Status: Completed
• Phase: Phase 4
• Start date: November 18, 2020
• Est. completion date: March 8, 2022

Study information

• Verified date: June 2022
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 8, 2022
• Est. primary completion date: March 8, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Analgesia
• Cardiac Output, Low
• Hypovolemia

Intervention

Procedure:
• Lower body negative pressure (LBNP)
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.

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac output	Cardiac output as measured by suprasternal Doppler and/ or non-invasive (volume clamp) pulse contour analysis.	Measured continuously during LBNP-exposure.
Secondary	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	15 minutes
Secondary	Mean arterial pressure	Change in mean arterial blood pressure with increasing LBNP, as measured by the volume-clamp method.	Measured continuously during LBNP-exposure.
Secondary	Stroke volume	Change in cardiac stroke volume with increasing LBNP, as measured by suprasternal Doppler and/ or the volume-clamp method.	Measured continuously during LBNP-exposure.