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

DNA Damage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00854178
• Other study ID #: upeclin/HC/FMB-Unesp-20
• 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

Related Conditions & MeSH terms

• DNA Damage
• Patients in Good Health
• Types of General Anesthesia

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