CytokinesNCT01231477
Cytokines and Sevoflurane During Surgery
An observational study of Cytokines and Inflammatory, run by UPECLIN HC FM Botucatu Unesp at 1 site in Brazil.
Trial summary
The aim of the present study was to evaluate the effects of anaesthesia with sevoflurane and surgery on cytokines response. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Cytokines, Inflammatory, Sevoflurane
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2009to Jun 2010
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Thirty adult patients ASA I physical status were allocated in 2 grups: 15 volunteers, not submitted to anesthesia and surgery, and 15 patients scheduled for tympanoplasty or septoplasty anesthetized with sevoflurane at 2,5%. Blood samples were drawn at 4 moments: before induction of anaesthesia, before surgery, at 120 minutes after anaesthesia induction, and on the postoperative first day. Blood samples from volunteers were drawn only once.
Who may be able to join
- both gender, ASA I physical status, 18-50 years old, tympanoplasty and septoplasty.
Who cannot join
- Malignant or genetical diseases; diabetes; smoking; elicit drugs, recent RX radiation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Inhalation Anaesthesia With Sevoflurane on Cytokine Response in Patients Submitted to Otorhinolaryngological Surgery
The aim of the present study was to evaluate the effects of anaesthesia with sevoflurane and surgery on cytokines response.
- Conditions
- Cytokines, Inflammatory, Sevoflurane
- Keywords
- anaesthetic techniques, inhalation, sevoflurane, Cytokines, Immune response
- Medical subject headings
- Respiratory Aspiration
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 |
|---|---|---|
| Volunteers | Healthy volunteers not submitted to anesthesia nor surgery. | |
| Sevoflurane Group | This group was submitted to inhalational anesthesia with sevoflurane and otorhinolaryngological surgery. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2010 (estimated)
- Study startJul 2009
- Primary completionDec 2009
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CytokinesStudies 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
- 30 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
- Jose EB Orosz, MD, Principal investigator, Botucatu Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01231477
- Sponsor's protocol ID
- JEO4531
- Status last verified
- Oct 2010
- First submitted
- 29 Oct 2010
- Last updated
- 1 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Inhalation Anaesthesia With Sevoflurane on Cytokine Response in Patients Submitted to Otorhinolaryngological Surgery
- ClinicalTrials.gov ID
- NCT01231477
- Acronym / sponsor ID
- JEO4531
- Conditions
- Cytokines, Inflammatory, Sevoflurane
- Keywords
- anaesthetic techniques, inhalation, sevoflurane, Cytokines, Immune response
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 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
- Jul 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 1 Nov 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 the present study was to evaluate the effects of anaesthesia with sevoflurane and surgery on cytokines response.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Volunteers | – | –Healthy volunteers not submitted to anesthesia nor surgery. |
| Sevoflurane Group | – | –This group was submitted to inhalational anesthesia with sevoflurane and otorhinolaryngological surgery. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Thirty adult patients ASA I physical status were allocated in 2 grups: 15 volunteers, not submitted to anesthesia and surgery, and 15 patients scheduled for tympanoplasty or septoplasty anesthetized with sevoflurane at 2,5%. Blood samples were drawn at 4 moments: before induction of anaesthesia, before surgery, at 120 minutes after anaesthesia induction, and on the postoperative first day. Blood samples from volunteers were drawn only once.
Key inclusion criteria (1 listed)
- both gender, ASA I physical status, 18-50 years old, tympanoplasty and septoplasty.
Key exclusion criteria (1 listed)
- Malignant or genetical diseases; diabetes; smoking; elicit drugs, recent RX radiation.
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
Not reported in the source record.
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 1 Nov 2010.
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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.
Jose EB Orosz, MD principal investigator
Botucatu Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cytokines and Inflammatory, 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 1 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: finished, as of the sponsor's last update on 1 Nov 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.
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.
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 1 Nov 2010.