Clinical trial NCT01111227: Inflammatory Cytokines Profile in Individuals Subjected to Surgical Procedures Using Propofol or Isoflurane
Official title: Inflammatory Cytokines Profile in Individuals Subjected to Surgical Procedures Using Propofol or Isoflurane.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Patients in Good Health
Keywords: cytokines
propofol
isoflurane
flow cytometry
Types of General Anesthesia
Lead sponsor: UPECLIN HC FM Botucatu Unesp
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2010-04-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Evaluation of cytokines profile
timeFrame: Before surgery and anesthesia, 2h after anesthesia and at the following day of the surgery
Secondary outcomes:
measure: Evaluation of pro and anti-inflammatory cytokines
timeFrame: before surgery and anesthesia, 2h after anesthesia and at the following day of the surgery
Other outcomes:
Locations:
city: Botucatu
country: Brazil
facility: Botucatu Medical School, UNESP
state: São Paulo
Study officials:
affiliation: Department of Pathology, Botucatu Medical School, São Paulo State University, UNESP
name: Marina Á Mazoti, MsC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.