Overview

This trial is active, not recruiting.

Condition hemolysis
Treatment propofol
Sponsor Centro Medico Campinas
Start date November 2008
End date May 2009
Trial size 60 participants
Trial identifier NCT00792779, CAAE - 0023.0.263.000-08

Summary

The purpose of this study is to determine if propofol could protect erythrocytes by directly scavenging free radicals from the blood current and increasing resistance of their cell membranes in patients submitted to gastroplasty.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment

Primary Outcomes

Measure
Count erythrocytes
time frame: After 10 hours post-surgery

Secondary Outcomes

Measure
Bilirubins(direct and indirect)
time frame: After 10 hours post-surgery

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - patients between BMI 40-50 kg/m2 Exclusion Criteria: - patients with BMI under 40 kg/m2 and over 50 kg/m2 - alcohol users - illicit-drug users - patients in regular use of anti-depressants, proton bomb inhibitors or calcium canal blockers - patients transfused either recently, during the intra-operative period or within 10 hours post-operative - patients previously known to be hypersensitive to any drug that is used during the study - patients with any psychiatric disorder or dementia

Additional Information

Official title Protective Effect of Propofol Against Hemolysis in Patients Submitted to Gastroplasty
Principal investigator Ricardo F Simoni, MD
Trial information was received from ClinicalTrials.gov and was last updated in November 2009.
Information provided to ClinicalTrials.gov by Centro Medico Campinas.