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Protective Effect of Propofol Against Hemolysis in Patients Submitted to Gastroplasty

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2009 by Centro Medico Campinas.
Recruitment status was:  Active, not recruiting
Information provided by:
Centro Medico Campinas Identifier:
First received: November 17, 2008
Last updated: November 4, 2009
Last verified: November 2009
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 Intervention
Hemolysis Drug: Propofol

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Centro Medico Campinas:

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

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

Estimated Enrollment: 60
Study Start Date: November 2008
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
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 µ and 8.0 η, respectively. The patients in the Sevoflurane Group (SG) will be induced with remifentanil TCI at target dose of 8.0 η and etomidate 0.5 in bolus.

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

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00792779

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

Responsible Party: Ricardo Francisco Simoni, Fundação Centro Médico de Campinas Identifier: NCT00792779     History of Changes
Other Study ID Numbers: CAAE - 0023.0.263.000-08
Study First Received: November 17, 2008
Last Updated: November 4, 2009

Keywords provided by Centro Medico Campinas:
Morbid obesity
General anaesthesia

Additional relevant MeSH terms:
Pathologic Processes
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics processed this record on August 21, 2017