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Protective Effect of Propofol Against Hemolysis in Patients Submitted to Gastroplasty

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Centro Medico Campinas.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Centro Medico Campinas
ClinicalTrials.gov Identifier:
NCT00792779
First received: November 17, 2008
Last updated: November 4, 2009
Last verified: November 2009
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Protective Effect of Propofol Against Hemolysis in Patients Submitted to Gastroplasty

Resource links provided by NLM:

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

Further study details as provided by Centro Medico Campinas:

Primary Outcome Measures:
  • Count erythrocytes [ Time Frame: After 10 hours post-surgery ] [ Designated as safety issue: Yes ]

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

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 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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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
Study First Received: November 17, 2008
Last Updated: November 4, 2009
Health Authority: Brazil: National Committee of Ethics in Research

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

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

ClinicalTrials.gov processed this record on June 18, 2013