AnesthesiaPhase 4NCT03283410
Determination of Propofol Target Concentration for Young and Elderly by Suppression Rate Analysis
A Phase 4 study testing Propofol in people with Anesthesia, run by Brasilia University Hospital.
Trial summary
Propofol's dose-response curve is know for the average adult but propofol's plasmatic concentration under total intravenous anesthesia differences between young and elderly must be modeled. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- Propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 30 Jan 2017to 30 Jan 2017
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Both sex
- Between 18-28 or 65-75 years old
- ASA physical status I or II
- no pre-anesthetic medications prescribed
- scheduled for surgery under general anesthesia
- willing to participate and sign informed consent.
Who cannot join
- Contraindications for propofol usage
- history of neurologic or psychiatric diseases
- drug abusers
- users of drugs that alter central nervous system
- pregnancy
- emergency surgeries
- rapid sequence intubation.
About this study
Propofol's dose-response curve is know for the average adult but propofol's plasmatic concentration under total intravenous anesthesia differences between young and elderly must be modeled. Adaptative clinical trial (Dixon's Up and Down) for determination of ED95% of propofol concentration for hypnosis under general anesthesia for young and elderly adults.
Read the detailed description
Propofol's dose-response curve is know for the average adult but propofol's plasmatic concentration under total intravenous anesthesia differences between young and elderly must be modeled. Method: adaptative clinical trial (Dixon's Up and Down method) for determination of ED95% of propofol concentration (plasmatic, Marsh model) for hypnosis (BIS ranging from 40 to 60) under general anesthesia for young and elderly adults.
- Conditions
- Anesthesia
- Being tested
- Propofol
- Keywords
- propofol, dose-response, elderly, young adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Also called Diprivan
Propofol plasmatic concentration (Marsh)
| Study group | Role | What they receive |
|---|---|---|
| Single Study Arm | Experimental | All patients will be sequentially allocated in the single study arm. All patients will receive some propofol dose. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
BIS value greater than 60 or lower than 40 during general anesthesia
BIS value greater than 60 or lower than 40 during general anesthesia
Measured: BIS value greater than 60 or lower than 40 during general anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2017
- Study start30 Jan 2017
- Primary completion30 Jan 2017
- Study completion30 Jan 2017
Why it stopped: Local problems with BIS monitor, we wont have it anymore.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
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 Guimaraes, MsC, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03283410
- Sponsor's protocol ID
- CAEE 41471115.1.0000.5558
- Status last verified
- Sep 2017
- First submitted
- 29 May 2015
- Last updated
- 14 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Propofol Target Concentration for Young and Elderly by Suppression Rate Analysis
- ClinicalTrials.gov ID
- NCT03283410
- Acronym / sponsor ID
- CAEE 41471115.1.0000.5558
- Conditions
- Anesthesia
- Keywords
- propofol, dose-response, elderly, young adults
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Local problems with BIS monitor, we wont have it anymore.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Brasilia University HospitalUniversity, hospital or other
- Study start
- 30 Jan 2017 (actual)
- Primary completion
- 30 Jan 2017 (actual)
- Study completion
- 30 Jan 2017 (actual)
- First posted
- 14 Sep 2017 (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.
Propofol's dose-response curve is know for the average adult but propofol's plasmatic concentration under total intravenous anesthesia differences between young and elderly must be modeled. Adaptative clinical trial (Dixon's Up and Down) for determination of ED95% of propofol concentration for hypnosis under general anesthesia for young and elderly adults.
Detailed description
Propofol's dose-response curve is know for the average adult but propofol's plasmatic concentration under total intravenous anesthesia differences between young and elderly must be modeled. Method: adaptative clinical trial (Dixon's Up and Down method) for determination of ED95% of propofol concentration (plasmatic, Marsh model) for hypnosis (BIS ranging from 40 to 60) under general anesthesia for young and elderly adults.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Study Arm | Experimental | Drug: PropofolAll patients will be sequentially allocated in the single study arm. All patients will receive some propofol dose. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Both sex
- Between 18-28 or 65-75 years old
- ASA physical status I or II
- no pre-anesthetic medications prescribed
- scheduled for surgery under general anesthesia
Key exclusion criteria (7 listed)
- Contraindications for propofol usage
- history of neurologic or psychiatric diseases
- drug abusers
- users of drugs that alter central nervous system
- pregnancy
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 |
|---|---|---|
| PropofolAlso: DiprivanPropofol plasmatic concentration (Marsh) | Drug | Single Study Arm |
Primary outcome
BIS value greater than 60 or lower than 40 during general anesthesia
Time frame: BIS value greater than 60 or lower than 40 during general anesthesia
BIS value greater than 60 or lower than 40 during general anesthesia
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2017.
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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 Guimaraes, MsC principal investigator
Professor
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propofol in people with Anesthesia, run by Brasilia University Hospital.
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 6 inclusion and 7 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: withdrawn, as of the sponsor's last update on 14 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
BIS value greater than 60 or lower than 40 during general anesthesia (time frame: BIS value greater than 60 or lower than 40 during general anesthesia). 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 14 Sep 2017.