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

NCT ID: NCT00854178

Last Updated: 2010-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2009-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Patients in Good Health Types of General Anesthesia DNA Damage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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2

Group Type EXPERIMENTAL

Comparison of two anesthetic drugs

Intervention Type DRUG

Isoflurane 1,0 minimum alveolar concentration Propofol 2mg/kg and 4ug/ml

Interventions

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Comparison of two anesthetic drugs

Isoflurane 1,0 minimum alveolar concentration Propofol 2mg/kg and 4ug/ml

Intervention Type DRUG

Other Intervention Names

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Diprivan Isoflurane

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

UPECLIN HC FM Botucatu Unesp

OTHER

Sponsor Role lead

Responsible Party

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São Paulo State University, UNESP

Principal Investigators

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Mariana G Braz, MsC

Role: PRINCIPAL_INVESTIGATOR

Department of Pathology, Botucatu Medical School, São Paulo State University, UNESP

Locations

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Botucatu Medical School, UNESP

Botucatu, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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upeclin/HC/FMB-Unesp-20

Identifier Type: -

Identifier Source: org_study_id

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