HypovolemiaPhase 4NCT04641949
Methoxyflurane and Fentanyl in LBNP
A Phase 4 study testing Lower body negative pressure (LBNP) in people with Hypovolemia and Cardiac Output, Low, run by Oslo University Hospital at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypovolemia, Cardiac Output, Low, Analgesia
- What is being tested?
- Lower body negative pressure (LBNP)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteNorway
- Study dates
- 18 Nov 2020to 8 Mar 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Methoxyflurane and Fentanyl in the Lower Body Negative Pressure Model of Hypovolemia in Healthy Volunteers; a Randomized, Placebo-controlled Crossover Study
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.
Read the 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.
- Conditions
- Hypovolemia, Cardiac Output, Low, Analgesia
- Being tested
- Lower body negative pressure (LBNP)
- Keywords
- Methoxyflurane, Fentanyl
- Medical subject headings
- Hypovolemia, Cardiac Output, Low, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lower body negative pressure (LBNP)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Methoxyflurane | Active comparator | Inhalation methoxyflurane 99,9%, 3 ml, single dose. Intravenous NaCl 9 mg/ml, XX ml, single dose. Receives: Procedure: Lower body negative pressure (LBNP) |
| Fentanyl | Active comparator | Intravenous fentanyl 50 microgr/ml, XX ml, single dose Inhalation NaCl 9 mg/ml, 3 ml, single dose. Receives: Procedure: Lower body negative pressure (LBNP) |
| Placebo | Placebo comparator | Intravenous NaCl 9 mg/ml, XX ml, single dose. Inhalation NaCl 9 mg/ml, 3 ml, single dose. Receives: Procedure: Lower body negative pressure (LBNP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac output
Cardiac output as measured by suprasternal Doppler and/ or non-invasive (volume clamp) pulse contour analysis.
Measured: Measured continuously during LBNP-exposure.
Secondary outcomes (3)
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
Measured: 15 minutes
Mean arterial pressure
Change in mean arterial blood pressure with increasing LBNP, as measured by the volume-clamp method.
Measured: Measured continuously during LBNP-exposure.
Stroke volume
Change in cardiac stroke volume with increasing LBNP, as measured by suprasternal Doppler and/ or the volume-clamp method.
Measured: Measured continuously during LBNP-exposure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2020
- Study start18 Nov 2020
- Primary completion8 Mar 2022
- Study completion8 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypovolemiaStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, placebo controlled, crossover study.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lars Øivind Høiseth, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04641949
- Sponsor's protocol ID
- lbnp_methoxy_fent_2019
- Status last verified
- Jun 2022
- First submitted
- 18 Nov 2020
- Last updated
- 30 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hoiseth LO, Fjose LO, Hisdal J, Comelon M, Rosseland LA, Lenz H. Haemodynamic effects of methoxyflurane versus fentanyl and placebo in hypovolaemia: a randomised, double-blind crossover study in healthy volunteers. BJA Open. 2023 Jun 28;7:100204. doi: 10.1016/j.bjao.2023.100204. eCollection 2023 Sep.
PubMed 37638077
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methoxyflurane and Fentanyl in the Lower Body Negative Pressure Model of Hypovolemia in Healthy Volunteers; a Randomized, Placebo-controlled Crossover Study
- ClinicalTrials.gov ID
- NCT04641949
- Acronym / sponsor ID
- lbnp_methoxy_fent_2019
- Conditions
- Hypovolemia, Cardiac Output, Low, Analgesia
- Keywords
- Methoxyflurane, Fentanyl
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 18 Nov 2020 (actual)
- Primary completion
- 8 Mar 2022 (actual)
- Study completion
- 8 Mar 2022 (actual)
- First posted
- 24 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Randomized, placebo controlled, crossover study.
| Arm | Type | Receives |
|---|---|---|
| Methoxyflurane | Active comparator | Procedure: Lower body negative pressure (LBNP)Inhalation methoxyflurane 99,9%, 3 ml, single dose. Intravenous NaCl 9 mg/ml, XX ml, single dose. |
| Fentanyl | Active comparator | Procedure: Lower body negative pressure (LBNP)Intravenous fentanyl 50 microgr/ml, XX ml, single dose Inhalation NaCl 9 mg/ml, 3 ml, single dose. |
| Placebo | Placebo comparator | Procedure: Lower body negative pressure (LBNP)Intravenous NaCl 9 mg/ml, XX ml, single dose. Inhalation NaCl 9 mg/ml, 3 ml, single dose. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Fentanyl, Methoxyflurane, Placebo |
Primary outcome
Cardiac output
Time frame: Measured continuously during LBNP-exposure.
Cardiac output as measured by suprasternal Doppler and/ or non-invasive (volume clamp) pulse contour analysis.
3 secondary outcomes
Time to hemodynamic decompensation
Time frame: 15 minutes
Mean arterial pressure
Time frame: Measured continuously during LBNP-exposure.
Stroke volume
Time frame: Measured continuously during LBNP-exposure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
- Derived from this study: PubMed 37638077Hoiseth LO, Fjose LO, Hisdal J, Comelon M, Rosseland LA, Lenz H. Haemodynamic effects of methoxyflurane versus fentanyl and placebo in hypovolaemia: a randomised, double-blind crossover study in healthy volunteers. BJA Open. 2023 Jun 28;7:100204. doi: 10.1016/j.bjao.2023.100204. eCollection 2023 Sep.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lower body negative pressure (LBNP) in people with Hypovolemia and Cardiac Output, Low, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac output (time frame: Measured continuously during LBNP-exposure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04641949, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2022.