Hemodynamic Responses to PropofolNCT02442232
Hemodynamic Changes After Anesthesia With Propofol: Study of Biomarkers
An observational study of Hemodynamic Responses to Propofol, run by Conselho Nacional de Desenvolvimento Científico e Tecnológico.
Trial summary
The purpose of this study is to evaluate biomarkers affecting the hemodynamic responses to propofol. Particularly, the investigators will assess the effects of polymorphisms in NOS3 and PRKCA genes on hemodynamic responses to propofol and the effects of these polymorphisms on biomarkers related to nitric oxide after… Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemodynamic Responses to Propofol
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to May 2016
- Phase
- Observational
- 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients under propofol anesthesia
Who may be able to join
- ASA I or II
- BMI lower 30 kg/m2
Who cannot join
- Severe hypertension
- Previous stroke
- Previous infarction
- Uncontrolled respiratory, renal, hepatic and hematological diseases.
About this study
The purpose of this study is to evaluate biomarkers affecting the hemodynamic responses to propofol. Particularly, the investigators will assess the effects of polymorphisms in NOS3 and PRKCA genes on hemodynamic responses to propofol and the effects of these polymorphisms on biomarkers related to nitric oxide after propofol anesthesia. In addition, the investigators will evaluate the effects of propofol anesthesia on biomarkers related to nitric oxide in hypertensive patients chronically treated with angiotensin-converting enzyme inhibitors.
- Conditions
- Hemodynamic Responses to Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Normotensive | Not described | |
| Hypertensive taking ACEi | Not described | |
| Hypertensive not taking ACEi | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure
Measured: 10 minutes
Diastolic blood pressure
Measured: 10 minutes
Mean blood pressure
Measured: 10 minutes
Heart rate
Measured: 10 minutes
Plasma nitrite levels
Measured: 10 minutes
Plasma nitrate levels
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2015 (estimated)
- Study startAug 2015
- Primary completionDec 2015
- Study completionMay 2016
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 Hemodynamic Responses to PropofolStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gustavo Henrique Oliveira de Paula, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02442232
- Sponsor's protocol ID
- CNPq
- Status last verified
- Aug 2016
- First submitted
- 7 May 2015
- Last updated
- 26 Aug 2016
- Results posted
- No
Publications
Oliveira-Paula GH, Coeli-Lacchini FB, Ferezin LP, Ferreira GC, Pinheiro LC, Paula-Garcia WN, Garcia LV, Tanus-Santos JE, Lacchini R. Arginase II polymorphisms modify the hypotensive responses to propofol by affecting nitric oxide bioavailability. Eur J Clin Pharmacol. 2021 Jun;77(6):869-877. doi: 10.1007/s00228-020-03059-9. Epub 2021 Jan 7.
PubMed 33410970
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Changes After Anesthesia With Propofol: Study of Biomarkers
- ClinicalTrials.gov ID
- NCT02442232
- Acronym / sponsor ID
- CNPq
- Conditions
- Hemodynamic Responses to Propofol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Conselho Nacional de Desenvolvimento Científico e TecnológicoOther government
- Study start
- Aug 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 13 May 2015 (estimated)
- 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 purpose of this study is to evaluate biomarkers affecting the hemodynamic responses to propofol. Particularly, the investigators will assess the effects of polymorphisms in NOS3 and PRKCA genes on hemodynamic responses to propofol and the effects of these polymorphisms on biomarkers related to nitric oxide after propofol anesthesia. In addition, the investigators will evaluate the effects of propofol anesthesia on biomarkers related to nitric oxide in hypertensive patients chronically treated with angiotensin-converting enzyme inhibitors.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normotensive | – | – |
| Hypertensive taking ACEi | – | – |
| Hypertensive not taking ACEi | – | – |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients under propofol anesthesia
Key inclusion criteria (2 listed)
- ASA I or II
- BMI lower 30 kg/m2
Key exclusion criteria (4 listed)
- Severe hypertension
- Previous stroke
- Previous infarction
- Uncontrolled respiratory, renal, hepatic and hematological diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Systolic blood pressure
Time frame: 10 minutes
Diastolic blood pressure
Time frame: 10 minutes
Mean blood pressure
Time frame: 10 minutes
Heart rate
Time frame: 10 minutes
Plasma nitrite levels
Time frame: 10 minutes
Plasma nitrate levels
Time frame: 10 minutes
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 26 Aug 2016.
- Derived from this study: PubMed 33410970Oliveira-Paula GH, Coeli-Lacchini FB, Ferezin LP, Ferreira GC, Pinheiro LC, Paula-Garcia WN, Garcia LV, Tanus-Santos JE, Lacchini R. Arginase II polymorphisms modify the hypotensive responses to propofol by affecting nitric oxide bioavailability. Eur J Clin Pharmacol. 2021 Jun;77(6):869-877. doi: 10.1007/s00228-020-03059-9. Epub 2021 Jan 7.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemodynamic Responses to Propofol, run by Conselho Nacional de Desenvolvimento Científico e Tecnológico.
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 2 inclusion and 4 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 26 Aug 2016. 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.
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?
Systolic blood pressure (time frame: 10 minutes). The study lists 6 primary outcomes in all. 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 NCT02442232, 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 26 Aug 2016.