Methoxyflurane and Fentanyl in LBNP

University of Oslo (UIO)

Status and phase: Completed; Phase 4

Conditions: Hypovolemia; Analgesia; Cardiac Output, Low

Treatments: Procedure: Lower body negative pressure (LBNP)

Study type: Interventional

Funder types: Other

Identifiers

NCT04641949

lbnp_methoxy_fent_2019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

---

15 participants in 3 patient groups, including a placebo group

Methoxyflurane

Active Comparator group

Description:

Inhalation methoxyflurane 99,9%, 3 ml, single dose. Intravenous NaCl 9 mg/ml, XX ml, single dose.

Treatment:

Procedure: Lower body negative pressure (LBNP)

Fentanyl

Active Comparator group

Description:

Intravenous fentanyl 50 microgr/ml, XX ml, single dose Inhalation NaCl 9 mg/ml, 3 ml, single dose.

Treatment:

Procedure: Lower body negative pressure (LBNP)

Placebo

Placebo Comparator group

Description:

Intravenous NaCl 9 mg/ml, XX ml, single dose. Inhalation NaCl 9 mg/ml, 3 ml, single dose.

Treatment:

Procedure: Lower body negative pressure (LBNP)