Patients in Good HealthPhase 4NCT01111227
Inflammatory Cytokines Profile in Individuals Subjected to Surgical Procedures Using Propofol or Isoflurane
A Phase 4 study testing Propofol and isoflurane in people with Patients in Good Health, run by UPECLIN HC FM Botucatu Unesp at 1 site in Brazil.
Trial summary
The aim of this study is to assess the profile of cytokines IL-1beta, IL-6, IL-8, IL-10, IL-12 and TNF-alpha under inhalation anesthesia with isoflurane and intravenous anesthesia with propofol in healthy patients subjected to minimally invasive elective surgeries. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Patients in Good Health
- What is being tested?
- Propofol and isoflurane
- How many people
- 40 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
Official title: Inflammatory Cytokines Profile in Individuals Subjected to Surgical Procedures Using Propofol or Isoflurane.
The aim of this study is to assess the profile of cytokines IL-1beta, IL-6, IL-8, IL-10, IL-12 and TNF-alpha under inhalation anesthesia with isoflurane and intravenous anesthesia with propofol in healthy patients subjected to minimally invasive elective surgeries.
Read the detailed description
Twenty ASA-I patients, subjected to otorhinolaryngology surgery, were randomly allocated in one group to receive anesthesia with isoflurane 1 MAC (minimum alveolar concentration) (n = 20). Other group with twenty ASA-I patients received propofol 2 to 4 microgram mL-1 (n = 20).
Fentanyl 5 mg kg-1 and rocuronium bromide 0.6 mg kg-1 were also administered to all patients. Venous blood (10 mL) was collected from each patient at each of the following times: before the beginning of surgery and anesthesia (T1), 2 h after the beginning of surgery (T2), and on the day after the anesthetic-surgical procedure (T3).
Plasma concentrations of interleukins IL-1beta, IL-6, IL-8, IL-10 and IL-12 and tumor necrosis factor (TNF-alpha) were measured in each sample through flow cytometry technique by using the method Cytometric Bead Array (CBA). Venous blood samples from fifteen volunteers not subjected to stress were also collected as control, and the same cytokines were measured.
- Conditions
- Patients in Good Health
- Being tested
- Propofol and isoflurane
- Keywords
- cytokines, propofol, isoflurane, flow cytometry, Types of General Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propofol and isofluraneDrug
Also called Diprivan, isoflurane
Comparison of two anesthetic drugs
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of cytokines profile
Measured: Before surgery and anesthesia, 2h after anesthesia and at the following day of the surgery
Secondary outcomes (1)
Evaluation of pro and anti-inflammatory cytokines
Measured: before surgery and anesthesia, 2h after anesthesia and at the following day of the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2010 (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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 40 participants (actual)
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
- Marina Á Mazoti, MsC, Principal investigator, Department of Pathology, Botucatu Medical School, São Paulo State University, UNESP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01111227
- Sponsor's protocol ID
- upeclin/HC/FMB-Unesp-40
- Status last verified
- Apr 2010
- First submitted
- 11 Mar 2010
- Last updated
- 27 Apr 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mazoti MA, Braz MG, de Assis Golim M, Braz LG, Dias NH, Salvadori DM, Braz JR, Fecchio D. Comparison of inflammatory cytokine profiles in plasma of patients undergoing otorhinological surgery with propofol or isoflurane anesthesia. Inflamm Res. 2013 Oct;62(10):879-85. doi: 10.1007/s00011-013-0643-y. Epub 2013 Jun 22.
PubMed 23793449
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Cytokines Profile in Individuals Subjected to Surgical Procedures Using Propofol or Isoflurane.
- ClinicalTrials.gov ID
- NCT01111227
- Acronym / sponsor ID
- upeclin/HC/FMB-Unesp-40
- Conditions
- Patients in Good Health
- Keywords
- cytokines, propofol, isoflurane, flow cytometry, Types of General Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- 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
- 27 Apr 2010 (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 aim of this study is to assess the profile of cytokines IL-1beta, IL-6, IL-8, IL-10, IL-12 and TNF-alpha under inhalation anesthesia with isoflurane and intravenous anesthesia with propofol in healthy patients subjected to minimally invasive elective surgeries.
Detailed description
Twenty ASA-I patients, subjected to otorhinolaryngology surgery, were randomly allocated in one group to receive anesthesia with isoflurane 1 MAC (minimum alveolar concentration) (n = 20). Other group with twenty ASA-I patients received propofol 2 to 4 microgram mL-1 (n = 20).
Fentanyl 5 mg kg-1 and rocuronium bromide 0.6 mg kg-1 were also administered to all patients. Venous blood (10 mL) was collected from each patient at each of the following times: before the beginning of surgery and anesthesia (T1), 2 h after the beginning of surgery (T2), and on the day after the anesthetic-surgical procedure (T3).
Plasma concentrations of interleukins IL-1beta, IL-6, IL-8, IL-10 and IL-12 and tumor necrosis factor (TNF-alpha) were measured in each sample through flow cytometry technique by using the method Cytometric Bead Array (CBA). Venous blood samples from fifteen volunteers not subjected to stress were also collected as control, and the same cytokines were measured.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
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 |
|---|---|---|
| Propofol and isofluraneAlso: Diprivan, isofluraneComparison of two anesthetic drugs | Drug | – |
Primary outcome
Evaluation of cytokines profile
Time frame: Before surgery and anesthesia, 2h after anesthesia and at the following day of the surgery
1 secondary outcome
Evaluation of pro and anti-inflammatory cytokines
Time frame: before surgery and anesthesia, 2h after anesthesia and at the following day of the 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 27 Apr 2010.
- Derived from this study: PubMed 23793449Mazoti MA, Braz MG, de Assis Golim M, Braz LG, Dias NH, Salvadori DM, Braz JR, Fecchio D. Comparison of inflammatory cytokine profiles in plasma of patients undergoing otorhinological surgery with propofol or isoflurane anesthesia. Inflamm Res. 2013 Oct;62(10):879-85. doi: 10.1007/s00011-013-0643-y. Epub 2013 Jun 22.
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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.
Marina Á Mazoti, 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 Propofol and isoflurane in people with Patients in Good Health, 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 27 Apr 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 cytokines profile (time frame: Before surgery and anesthesia, 2h after anesthesia and at the following day of the surgery). 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 NCT01111227, 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 27 Apr 2010.