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

NCT00854178 | Completed Phase 4

• 1 other identifier: upeclin/HC/FMB-Unesp-20
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

isoflurane; propofol; genotoxicity; gene expression; cytokines; apoptosis

Outcome Measures

Primary Outcomes (1)

• Evaluation of genotoxicity, gene expression, apoptosis and cytokines profile

  within 1 day after surgery

Study Arms (1)

2

EXPERIMENTAL

Drug: Comparison of two anesthetic drugs

Interventions

Comparison of two anesthetic drugs DRUG

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

Also known as: Diprivan, Isoflurane

2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients in good health American Society of Anesthesia status physical I
• elective minor surgery
• general anesthesia

You may not qualify if:

• smokers
• alcoholics
• previous medication or radiation

Sponsors & Collaborators

• UPECLIN HC FM Botucatu Unesp: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Botucatu Medical School, UNESP

Botucatu, São Paulo, 18618-000, Brazil

Location

MeSH Terms

Interventions

Propofol; Isoflurane

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers

Study Officials

• Mariana G Braz, MsC

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 2, 2009
• First Posted: March 3, 2009
• Study Start: March 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: January 6, 2010

Record last verified: 2010-01

Locations

BR (1)