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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00854178
Other study ID # upeclin/HC/FMB-Unesp-20
Secondary ID
Status Completed
Phase Phase 4
First received March 2, 2009
Last updated January 5, 2010
Start date March 2008
Est. completion date December 2009

Study information

Verified date January 2010
Source UPECLIN HC FM Botucatu Unesp
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date December 2009
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 50 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care


Intervention

Drug:
Comparison of two anesthetic drugs
Isoflurane 1,0 minimum alveolar concentration Propofol 2mg/kg and 4ug/ml

Locations

Country Name City State
Brazil Botucatu Medical School, UNESP Botucatu São Paulo

Sponsors (2)

Lead Sponsor Collaborator
UPECLIN HC FM Botucatu Unesp Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of genotoxicity, gene expression, apoptosis and cytokines profile within 1 day after surgery Yes
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