Toxicogenomic and Immunocytotoxic Effects of Propofol and Isoflurane Anesthetics in Patients Undergoing Elective Surgery

January 5, 2010 updated by: UPECLIN HC FM Botucatu Unesp
The purpose of this study is to evaluate if the anesthetics propofol and isoflurane can damage DNA, induce apoptosis, change expression of genes related to apoptosis and DNA repair and change cytokines profile in patients submitted to elective surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

It is expected that the results provide relevant information to understand the possible adverse effects of anesthetics and contribute to the establishment of strategies aimed at reducing the risks to exposed individuals.

Study Type

Interventional

Enrollment (Anticipated)

26

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • Botucatu, São Paulo, Brazil, 18618-000
        • Botucatu Medical School, UNESP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2
Drug: Comparison of two anesthetic drugs
Isoflurane 1,0 minimum alveolar concentration Propofol 2mg/kg and 4ug/ml
Other Names:
  • Diprivan
  • Isoflurane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of genotoxicity, gene expression, apoptosis and cytokines profile
Time Frame: within 1 day after surgery
within 1 day after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UPECLIN HC FM Botucatu Unesp

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

  • Principal Investigator: Mariana G Braz, MsC, Department of Pathology, Botucatu Medical School, São Paulo State University, UNESP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

March 2, 2009

First Submitted That Met QC Criteria

March 2, 2009

First Posted (Estimate)

March 3, 2009

Study Record Updates

Last Update Posted (Estimate)

January 6, 2010

Last Update Submitted That Met QC Criteria

January 5, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • upeclin/HC/FMB-Unesp-20

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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