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Methoxyflurane and Fentanyl in LBNP

Primary Purpose

Hypovolemia, Cardiac Output, Low, Analgesia

Status

Completed

Phase

Phase 4

Locations

Norway

Study Type

Interventional

Intervention

Lower body negative pressure (LBNP)

About this trial

This is an interventional basic science trial for Hypovolemia focused on measuring Methoxyflurane, Fentanyl

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Oslo University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Methoxyflurane

Fentanyl

Placebo

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Cardiac output

Cardiac output as measured by suprasternal Doppler and/ or non-invasive (volume clamp) pulse contour analysis.

Secondary Outcome Measures

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

Mean arterial pressure

Change in mean arterial blood pressure with increasing LBNP, as measured by the volume-clamp method.

Stroke volume

Change in cardiac stroke volume with increasing LBNP, as measured by suprasternal Doppler and/ or the volume-clamp method.

Full Information

NCT ID

NCT04641949

First Posted

November 18, 2020

Last Updated

June 28, 2022

Sponsor

Oslo University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04641949

Brief Title

Methoxyflurane and Fentanyl in LBNP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Completed

Study Start Date

November 18, 2020 (Actual)

Primary Completion Date

March 8, 2022 (Actual)

Study Completion Date

March 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Oslo University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypovolemia, Cardiac Output, Low, Analgesia

Keywords

Methoxyflurane, Fentanyl

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Model Description

Randomized, placebo controlled, crossover study.

Masking

ParticipantCare ProviderInvestigator

Masking Description

Both drug interventions (intravenous fentanyl and inhaled methoxyflurane) will have NaCl placebo comparators. As the methoxyflurane has a characteristic smell, some drops of methoxyflurane will be placed on the exterior of the placebo methoxyflurane inhalation devices. Further, the subjects will rinse the mouth with a mouthwash shortly before inhalation to cover the taste of methoxyflurane.

Allocation

Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Methoxyflurane

Arm Type

Active Comparator

Arm Description

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

Arm Title

Fentanyl

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Lower body negative pressure (LBNP)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Cardiac output

Description

Cardiac output as measured by suprasternal Doppler and/ or non-invasive (volume clamp) pulse contour analysis.

Time Frame

Measured continuously during LBNP-exposure.

Secondary Outcome Measure Information:

Title

Time to hemodynamic decompensation

Description

Time Frame

15 minutes

Title

Mean arterial pressure

Description

Change in mean arterial blood pressure with increasing LBNP, as measured by the volume-clamp method.

Time Frame

Measured continuously during LBNP-exposure.

Title

Stroke volume

Description

Change in cardiac stroke volume with increasing LBNP, as measured by suprasternal Doppler and/ or the volume-clamp method.

Time Frame

Measured continuously during LBNP-exposure.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Oslo University Hospital

City

Oslo

ZIP/Postal Code

0586

Country

Norway

12. IPD Sharing Statement

Plan to Share IPD

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Methoxyflurane and Fentanyl in LBNP

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