- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01231477
Cytokines and Sevoflurane During Surgery
October 29, 2010 updated by: UPECLIN HC FM Botucatu Unesp
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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São Paulo
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Botucatu, São Paulo, Brazil, 18618-970
- Botucatu Medical School
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
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.
Description
Inclusion Criteria:
- both gender, ASA I physical status, 18-50 years old, tympanoplasty and septoplasty.
Exclusion Criteria:
- Malignant or genetical diseases; diabetes; smoking; elicit drugs, recent RX radiation.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Volunteers
Healthy volunteers not submitted to anesthesia nor surgery.
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Sevoflurane Group
This group was submitted to inhalational anesthesia with sevoflurane and otorhinolaryngological surgery.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jose EB Orosz, MD, Botucatu Medical School
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2009
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
June 1, 2010
Study Registration Dates
First Submitted
October 29, 2010
First Submitted That Met QC Criteria
October 29, 2010
First Posted (Estimate)
November 1, 2010
Study Record Updates
Last Update Posted (Estimate)
November 1, 2010
Last Update Submitted That Met QC Criteria
October 29, 2010
Last Verified
October 1, 2010
More Information
Terms related to this study
Other Study ID Numbers
- JEO4531
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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