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

This study has been completed.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
UPECLIN HC FM Botucatu Unesp
ClinicalTrials.gov Identifier:
NCT01111227
First received: March 11, 2010
Last updated: April 26, 2010
Last verified: April 2010
  Purpose

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 Intervention Phase
Patients in Good Health
Drug: Propofol and isoflurane
Phase 4

Study Type: Interventional
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.

Resource links provided by NLM:


Further study details as provided by UPECLIN HC FM Botucatu Unesp:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 40
Study Start Date: March 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Propofol and isoflurane
    Comparison of two anesthetic drugs
    Other Names:
    • Diprivan
    • isoflurane
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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by UPECLIN HC FM Botucatu Unesp

Additional 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
Study First Received: March 11, 2010
Last Updated: April 26, 2010
Health Authority: Brazil: Ethics Committee

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

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

ClinicalTrials.gov processed this record on July 23, 2014