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Protective Effect of Propofol Against Hemolysis in Patients Submitted to Gastroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE November 17, 2008
First Posted Date  ICMJE November 18, 2008
Last Update Posted Date November 5, 2009
Study Start Date  ICMJE November 2008
Estimated Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 17, 2008)
Count erythrocytes [ Time Frame: After 10 hours post-surgery ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2008)
Bilirubins(direct and indirect) [ Time Frame: After 10 hours post-surgery ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Protective Effect of Propofol Against Hemolysis in Patients Submitted to Gastroplasty
Official Title  ICMJE Protective Effect of Propofol Against Hemolysis in Patients Submitted to Gastroplasty
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hemolysis
Intervention  ICMJE 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.
Study Arms  ICMJE Not Provided
Publications * Tsuchiya M, Asada A, Kasahara E, Sato EF, Shindo M, Inoue M. Antioxidant protection of propofol and its recycling in erythrocyte membranes. Am J Respir Crit Care Med. 2002 Jan 1;165(1):54-60.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 17, 2008)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2009
Estimated Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00792779
Other Study ID Numbers  ICMJE CAAE - 0023.0.263.000-08
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ricardo Francisco Simoni, Fundação Centro Médico de Campinas
Study Sponsor  ICMJE Centro Medico Campinas
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ricardo F Simoni, MD Fundação Centro Médico de Campinas
PRS Account Centro Medico Campinas
Verification Date November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP