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

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ClinicalTrials.gov Identifier: NCT00854178
Recruitment Status : Completed
First Posted : March 3, 2009
Last Update Posted : January 6, 2010
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
UPECLIN HC FM Botucatu Unesp

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Patients in Good Health Types of General Anesthesia DNA Damage Drug: Comparison of two anesthetic drugs Phase 4

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  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Toxicogenomic and Immunocytotoxic Effects of Propofol and Isoflurane Anesthetics in Patients Undergoing Elective Surgery
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

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Evaluation of genotoxicity, gene expression, apoptosis and cytokines profile [ Time Frame: within 1 day after 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): NCT00854178


Locations
Brazil
Botucatu Medical School, UNESP
Botucatu, São Paulo, Brazil, 18618-000
Sponsors and Collaborators
UPECLIN HC FM Botucatu Unesp
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

Responsible Party: Mariana Gobbo Braz, São Paulo State University, UNESP
ClinicalTrials.gov Identifier: NCT00854178     History of Changes
Other Study ID Numbers: upeclin/HC/FMB-Unesp-20
First Posted: March 3, 2009    Key Record Dates
Last Update Posted: January 6, 2010
Last Verified: January 2010

Keywords provided by UPECLIN HC FM Botucatu Unesp:
isoflurane
propofol
genotoxicity
gene expression
cytokines
apoptosis

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