HypotensionPhase 4NCT03595319
Median Sevoflurane Concentration for Hypotension Between Young and Elderlypatients: Adaptive Clinical Trial
A Phase 4 study testing Sevoflurane in people with Hypotension, run by Brasilia University Hospital at 1 site in Brazil.
Trial summary
Two arms: elder group, young group. Dixon's up and down adaptive methodology for ED50. Executed after Anesthesia induction for 10min without touching the patient after starting mechanical ventilation. Read more about this study
- Who is it for?
- Ages 19 to 120 years
- Conditions the study is for
- Hypotension
- What is being tested?
- Sevoflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 23 Jul 2018to 15 Feb 2019
- 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 19 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Understands experiment, is voluntary, signs informed consent;
- Does not take medication that influences arterial pressure;
- Normotensive.
Who cannot join
- Received any medication that influences arterial pressure before experiment;
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital Universitário de Brasilia
Brasília, Federal District, 70000000
Gabriel MN Guimarães, MD, MsC, +5561996455997, gabrielmng@gmail.com
Gabriel MN Guimarães, Md, MSc
About this study
Official title: Comparison of Median Alveolar Sevoflurane Concentration for Hypotension Between Young and Elderly Patients: Adaptive Clinical Trial
Two arms: elder group, young group. Dixon's up and down adaptive methodology for ED50. Executed after Anesthesia induction for 10min without touching the patient after starting mechanical ventilation.
Read the detailed description
This adaptive clinical trial will vary target end tidal sevoflurane by 0.4, then by 0.2 and by 0.1 thereafter in order to minimize sample size.
- Conditions
- Hypotension
- Being tested
- Sevoflurane
- Keywords
- Hypotension, Sevoflurane, Elderly
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
Inhaled sevoflurane until allocated dose (see adaptive protocol)
| Study group | Role | What they receive |
|---|---|---|
| Young patients | Experimental | Patients between 19 and 40 years-old Receives: Drug: Sevoflurane |
| Elder patients | Experimental | Older than 65 Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypotension incidence related to sevoflurane
Any mean arterial pressure drop > 10% compared to baseline
Measured: During the first 10 minutes after end tidal sevoflurane concentration stabilizes
Secondary outcomes (2)
Systolic hypotension
Systolic arterial pressure drop >10%
Measured: During the first 10 minutes after end tidal sevoflurane concentration stabilizes
Diastolic hypotension
Systolic arterial pressure drop >10%
Measured: During the first 10 minutes after end tidal sevoflurane concentration stabilizes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2018
- Study start23 Jul 2018
- Primary completion1 Oct 2018
- Study completion15 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypotensionStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- Adaptive up and down methodology. Anesthesia will be induced using etomidate, rocuronium and remifentanil. After intubation and mechanical ventilation, a high fresh gas flow and variable vaporizer target concentration will be used to stabilize the patient's target end tidal sevoflurane in less than two minutes. Each patient's target end tidal sevoflurane is determined by the concentration used in the previous patient of the same group and by the incidence of hypotension. If the previous patient suffered hypotension, next patient's target concentration will drop. If there was no hypotension, next patient's target concentration will rise. The first patient on each group will be 2%. Target end tidal will vary 0.4% until the first crossover, then drop to 0.2% until the second crossover and will vary 0.1% thereafter.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brasilia University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriel Magalhaes Nunes Guimaraes, Brasilia University Hospital
- Investigators
- Gabriel MN Guimarães, MD, MSc, Principal investigator, University of Brasilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03595319
- Sponsor's protocol ID
- TccFeliciaVictor2018
- Status last verified
- Oct 2018
- First submitted
- 12 Jul 2018
- Last updated
- 30 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Plan to share unidentified individual patient data in mendeley data.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Median Alveolar Sevoflurane Concentration for Hypotension Between Young and Elderly Patients: Adaptive Clinical Trial
- ClinicalTrials.gov ID
- NCT03595319
- Acronym / sponsor ID
- TccFeliciaVictor2018
- Conditions
- Hypotension
- Keywords
- Hypotension, Sevoflurane, Elderly
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Brasilia University HospitalUniversity, hospital or other
- Study start
- 23 Jul 2018 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 15 Feb 2019 (estimated)
- First posted
- 23 Jul 2018 (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.
Two arms: elder group, young group. Dixon's up and down adaptive methodology for ED50. Executed after Anesthesia induction for 10min without touching the patient after starting mechanical ventilation.
Detailed description
This adaptive clinical trial will vary target end tidal sevoflurane by 0.4, then by 0.2 and by 0.1 thereafter in order to minimize sample size.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Adaptive up and down methodology. Anesthesia will be induced using etomidate, rocuronium and remifentanil. After intubation and mechanical ventilation, a high fresh gas flow and variable vaporizer target concentration will be used to stabilize the patient's target end tidal sevoflurane in less than two minutes. Each patient's target end tidal sevoflurane is determined by the concentration used in the previous patient of the same group and by the incidence of hypotension. If the previous patient suffered hypotension, next patient's target concentration will drop. If there was no hypotension, next patient's target concentration will rise. The first patient on each group will be 2%. Target end tidal will vary 0.4% until the first crossover, then drop to 0.2% until the second crossover and will vary 0.1% thereafter.
| Arm | Type | Receives |
|---|---|---|
| Young patients | Experimental | Drug: SevofluranePatients between 19 and 40 years-old |
| Elder patients | Experimental | Drug: SevofluraneOlder than 65 |
Who may qualify
- Ages
- 19 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Understands experiment, is voluntary, signs informed consent;
- Does not take medication that influences arterial pressure;
- Normotensive.
Key exclusion criteria (1 listed)
- Received any medication that influences arterial pressure before experiment;
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 |
|---|---|---|
| SevofluraneInhaled sevoflurane until allocated dose (see adaptive protocol) | Drug | Elder patients, Young patients |
Primary outcome
Hypotension incidence related to sevoflurane
Time frame: During the first 10 minutes after end tidal sevoflurane concentration stabilizes
Any mean arterial pressure drop > 10% compared to baseline
2 secondary outcomes
Systolic hypotension
Time frame: During the first 10 minutes after end tidal sevoflurane concentration stabilizes
Diastolic hypotension
Time frame: During the first 10 minutes after end tidal sevoflurane concentration stabilizes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2018.
- Individual participant dataSharing planned: Yes. Plan to share unidentified individual patient data in mendeley data.
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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.
Gabriel MN Guimarães, MD, MSc principal investigator
University of Brasilia
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 Sevoflurane in people with Hypotension, run by Brasilia University Hospital at 1 site in Brazil.
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 1 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: status not confirmed, as of the sponsor's last update on 30 Oct 2018. 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 Brazil. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gabriel MN Guimarães, MD, MSc (+5561996455997, gguimaraes@unb.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypotension incidence related to sevoflurane (time frame: During the first 10 minutes after end tidal sevoflurane concentration stabilizes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Oct 2018.