Inflammatory Cytokines Profile in Individuals Subjected to Surgical Procedures Using Propofol or Isoflurane

NCT ID: NCT01111227

Last Updated: 2010-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2009-12-31

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Interventions

Propofol and isoflurane

Comparison of two anesthetic drugs

Intervention Type: DRUG

Other Intervention Names

Diprivan; isoflurane

Eligibility Criteria

Inclusion Criteria

• Patients in good health American Society of Anesthesia status physical I
• Elective minor surgery
• General anesthesia

Exclusion Criteria

• Smokers
• Alcoholics
• Previous medication or radiation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: collaborator

UPECLIN HC FM Botucatu Unesp

OTHER

Sponsor Role: lead

Responsible Party

São Paulo State University, UNESP

Principal Investigators

Marina Á Mazoti, MsC

Role: PRINCIPAL_INVESTIGATOR

Department of Pathology, Botucatu Medical School, São Paulo State University, UNESP

Locations

Botucatu Medical School, UNESP

Botucatu, São Paulo, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 23793449 (View on PubMed)

Other Identifiers

upeclin/HC/FMB-Unesp-40

Identifier Type: -

Identifier Source: org_study_id