Inflammatory Cytokines Profile in Individuals Subjected to Surgical Procedures Using Propofol or Isoflurane
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
|Official Title:||Inflammatory Cytokines Profile in Individuals Subjected to Surgical Procedures Using Propofol or Isoflurane.|
- Evaluation of cytokines profile [ Time Frame: Before surgery and anesthesia, 2h after anesthesia and at the following day of the surgery ] [ Designated as safety issue: Yes ]
- Evaluation of pro and anti-inflammatory cytokines [ Time Frame: before surgery and anesthesia, 2h after anesthesia and at the following day of the surgery ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2008|
|Study Completion Date:||December 2009|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Drug: Propofol and isoflurane
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01111227
|Botucatu Medical School, UNESP|
|Botucatu, São Paulo, Brazil, 18603-970|
|Principal Investigator:||Marina Á Mazoti, MsC||Department of Pathology, Botucatu Medical School, São Paulo State University, UNESP|