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

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ClinicalTrials.gov Identifier: NCT01111227
Recruitment Status : Completed
First Posted : April 27, 2010
Last Update Posted : April 27, 2010
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Patients in Good Health Drug: Propofol and isoflurane Phase 4

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Inflammatory Cytokines Profile in Individuals Subjected to Surgical Procedures Using Propofol or Isoflurane.
Study Start Date : March 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Drug: Propofol and isoflurane
    Comparison of two anesthetic drugs
    Other Names:
    • Diprivan
    • isoflurane


Primary Outcome Measures :
  1. Evaluation of cytokines profile [ Time Frame: Before surgery and anesthesia, 2h after anesthesia and at the following day of the surgery ]

Secondary Outcome Measures :
  1. Evaluation of pro and anti-inflammatory cytokines [ Time Frame: before surgery and anesthesia, 2h after anesthesia and at the following day of the surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01111227


Locations
Brazil
Botucatu Medical School, UNESP
Botucatu, São Paulo, Brazil, 18603-970
Sponsors and Collaborators
UPECLIN HC FM Botucatu Unesp
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Marina Á Mazoti, MsC Department of Pathology, Botucatu Medical School, São Paulo State University, UNESP

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Upeclin HC FM Botucatu Unesp, São Paulo State University, UNESP
ClinicalTrials.gov Identifier: NCT01111227     History of Changes
Other Study ID Numbers: upeclin/HC/FMB-Unesp-40
First Posted: April 27, 2010    Key Record Dates
Last Update Posted: April 27, 2010
Last Verified: April 2010

Keywords provided by UPECLIN HC FM Botucatu Unesp:
cytokines
propofol
isoflurane
flow cytometry
Types of General Anesthesia

Additional relevant MeSH terms:
Propofol
Isoflurane
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anesthetics, Inhalation