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

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:
NCT00854178
First received: March 2, 2009
Last updated: January 5, 2010
Last verified: January 2010
  Purpose

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 Intervention Phase
Patients in Good Health
Types of General Anesthesia
DNA Damage
Drug: Comparison of two anesthetic drugs
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: Toxicogenomic and Immunocytotoxic Effects of Propofol and Isoflurane Anesthetics in Patients Undergoing Elective Surgery

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Evaluation of genotoxicity, gene expression, apoptosis and cytokines profile [ Time Frame: within 1 day after surgery ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 26
Study Start Date: March 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2 Drug: Comparison of two anesthetic drugs
Isoflurane 1,0 minimum alveolar concentration Propofol 2mg/kg and 4ug/ml
Other Names:
  • Diprivan
  • Isoflurane

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: March 2, 2009
Last Updated: January 5, 2010
Health Authority: Brazil: National Committee of Ethics in Research

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

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

ClinicalTrials.gov processed this record on July 20, 2014