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

Phase 4

Completed

• Conditions: Patients in Good Health

• Registration Number: NCT01111227
• Lead Sponsor: UPECLIN HC FM Botucatu Unesp

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.

Study Timeline

• Study Start: 2008-03
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Study First Submitted: 2010-03-11
• Status Verified: 2010-04
• Study First Submitted QC: 2010-04-26
• Last Update Submitted: 2010-04-26
• Study First Posted: 2010-04-27
• Last Update Posted: 2010-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Evaluation of cytokines profile	Before surgery and anesthesia, 2h after anesthesia and at the following day of the surgery

Secondary Outcome Measures

Name	Time	Method
Evaluation of pro and anti-inflammatory cytokines	before surgery and anesthesia, 2h after anesthesia and at the following day of the surgery

Trial Locations

Locations (1)

Botucatu Medical School, UNESP; 🇧🇷 Botucatu, São Paulo, Brazil