Patients in Good HealthPhase 4NCT00854178
Toxicogenomic and Immunocytotoxic Effects of Propofol and Isoflurane Anesthetics in Patients Undergoing Elective Surgery
A Phase 4 study testing Comparison of two anesthetic drugs in people with Patients in Good Health and Types of General Anesthesia, run by UPECLIN HC FM Botucatu Unesp at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate if the anesthetics propofol and isoflurane can damage DNA, induce apoptosis, change expression of genes related to apoptosis and DNA repair and change cytokines profile in patients submitted to elective surgery. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Patients in Good Health, Types of General Anesthesia, DNA Damage
- What is being tested?
- Comparison of two anesthetic drugs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2008to Dec 2009
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients in good health American Society of Anesthesia status physical I
- elective minor surgery
- general anesthesia
Who cannot join
- smokers
- alcoholics
- previous medication or radiation
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate if the anesthetics propofol and isoflurane can damage DNA, induce apoptosis, change expression of genes related to apoptosis and DNA repair and change cytokines profile in patients submitted to elective surgery.
Read the detailed description
It is expected that the results provide relevant information to understand the possible adverse effects of anesthetics and contribute to the establishment of strategies aimed at reducing the risks to exposed individuals.
- Being tested
- Comparison of two anesthetic drugs
- Keywords
- isoflurane, propofol, genotoxicity, gene expression, cytokines, apoptosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison of two anesthetic drugsDrug
Also called Diprivan, Isoflurane
Isoflurane 1,0 minimum alveolar concentration Propofol 2mg/kg and 4ug/ml
| Study group | Role | What they receive |
|---|---|---|
| 2 | Experimental | Not described Receives: Drug: Comparison of two anesthetic drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of genotoxicity, gene expression, apoptosis and cytokines profile
Measured: within 1 day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2009 (estimated)
- Study startMar 2008
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients in Good HealthStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UPECLIN HC FM Botucatu Unesp
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Investigators
- Mariana G Braz, MsC, Principal investigator, Department of Pathology, Botucatu Medical School, São Paulo State University, UNESP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00854178
- Sponsor's protocol ID
- upeclin/HC/FMB-Unesp-20
- Status last verified
- Jan 2010
- First submitted
- 2 Mar 2009
- Last updated
- 6 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Toxicogenomic and Immunocytotoxic Effects of Propofol and Isoflurane Anesthetics in Patients Undergoing Elective Surgery
- ClinicalTrials.gov ID
- NCT00854178
- Acronym / sponsor ID
- upeclin/HC/FMB-Unesp-20
- Keywords
- isoflurane, propofol, genotoxicity, gene expression, cytokines, apoptosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- UPECLIN HC FM Botucatu UnespUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Mar 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 3 Mar 2009 (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 if the anesthetics propofol and isoflurane can damage DNA, induce apoptosis, change expression of genes related to apoptosis and DNA repair and change cytokines profile in patients submitted to elective surgery.
Detailed description
It is expected that the results provide relevant information to understand the possible adverse effects of anesthetics and contribute to the establishment of strategies aimed at reducing the risks to exposed individuals.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2 | Experimental | Drug: Comparison of two anesthetic drugs |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- patients in good health American Society of Anesthesia status physical I
- elective minor surgery
- general anesthesia
Key exclusion criteria (3 listed)
- smokers
- alcoholics
- previous medication or radiation
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 |
|---|---|---|
| Comparison of two anesthetic drugsAlso: Diprivan, IsofluraneIsoflurane 1,0 minimum alveolar concentration Propofol 2mg/kg and 4ug/ml | Drug | 2 |
Primary outcome
Evaluation of genotoxicity, gene expression, apoptosis and cytokines profile
Time frame: within 1 day after surgery
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 6 Jan 2010.
Related trials for Patients in Good Health
RecruitingObservational study
Brain Function and Psychological Changes Related to Cell Therapy for Autoimmune Hemolytic Anemia
CAR T-cell Therapy, Autoimmune Hemolytic Anemia
Active, not recruiting
The Acupuncture Treatment Effect in Patients With Schizophrenia
Mental Health
Not yet recruiting
The Impact of Equine-Assisted Therapy on Mental Health and Addictive Behaviors in Patients Receiving Addiction Treatment
Equine-assisted Therapy, Addiction
Active, not recruitingPhase 4
Comparison of Two Timings of Levothyroxine Intake in Hypothyroid Patients: A Cross-over Randomized Control Trial
Hypothyroidism Primary
Not yet recruiting
A Hybrid Effectiveness-Implementation and Cost-Utility Evaluation of a Support Programme for Informal Carers of People With Dementia in Primary Care (EsCuidar2)
Quality of Life
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.
Mariana G Braz, MsC principal investigator
Department of Pathology, Botucatu Medical School, São Paulo State University, UNESP
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 Comparison of two anesthetic drugs in people with Patients in Good Health and Types of General Anesthesia, run by UPECLIN HC FM Botucatu Unesp 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 3 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 6 Jan 2010. 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?
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?
Evaluation of genotoxicity, gene expression, apoptosis and cytokines profile (time frame: within 1 day after surgery). 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 6 Jan 2010.