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Protective Effect of Propofol Against Hemolysis in Patients Submitted to Gastroplasty

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ClinicalTrials.gov Identifier: NCT00792779
Recruitment Status : Unknown
Verified November 2009 by Centro Medico Campinas.
Recruitment status was:  Active, not recruiting
First Posted : November 18, 2008
Last Update Posted : November 5, 2009
Sponsor:
Information provided by:
Centro Medico Campinas

Brief 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.

Condition or disease Intervention/treatment
Hemolysis Drug: Propofol

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Protective Effect of Propofol Against Hemolysis in Patients Submitted to Gastroplasty
Study Start Date : November 2008
Estimated Primary Completion Date : May 2009
Estimated Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Propofol
U.S. FDA Resources


Intervention Details:
    Drug: Propofol
    Patients in the Propofol Group (PG) will be induced with target-controlled infusion (TCI) of propofol (Diprifusor, AstraZeneca) and remifentanil (Asena PK, Cardinal Health) at the target dose of 6.0 µg.ml-1 and 8.0 ηg.ml-1, respectively. The patients in the Sevoflurane Group (SG) will be induced with remifentanil TCI at target dose of 8.0 ηg.ml-1 and etomidate 0.5 mg.kg-1 in bolus.


Primary Outcome Measures :
  1. Count erythrocytes [ Time Frame: After 10 hours post-surgery ]

Secondary Outcome Measures :
  1. Bilirubins(direct and indirect) [ Time Frame: After 10 hours post-surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00792779


Locations
Brazil
Fundação Centro Médico de Campinas
Campinas, São Paulo, Brazil, 13084-000
Sponsors and Collaborators
Centro Medico Campinas
Investigators
Principal Investigator: Ricardo F Simoni, MD Fundação Centro Médico de Campinas

Publications:
Responsible Party: Ricardo Francisco Simoni, Fundação Centro Médico de Campinas
ClinicalTrials.gov Identifier: NCT00792779     History of Changes
Other Study ID Numbers: CAAE - 0023.0.263.000-08
First Posted: November 18, 2008    Key Record Dates
Last Update Posted: November 5, 2009
Last Verified: November 2009

Keywords provided by Centro Medico Campinas:
Morbid obesity
General anaesthesia
Propofol
Sevoflurane

Additional relevant MeSH terms:
Hemolysis
Pathologic Processes
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics