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Protective Effect of Propofol Against Hemolysis in Patients Submitted to Gastroplasty

Primary Purpose

Hemolysis

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Propofol
Sponsored by
Centro Medico Campinas
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemolysis focused on measuring Morbid obesity, General anaesthesia, Propofol, Sevoflurane

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fundação Centro Médico de Campinas

Outcomes

Primary Outcome Measures

Count erythrocytes

Secondary Outcome Measures

Bilirubins(direct and indirect)

Full Information

First Posted
November 17, 2008
Last Updated
November 4, 2009
Sponsor
Centro Medico Campinas
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1. Study Identification

Unique Protocol Identification Number
NCT00792779
Brief Title
Protective Effect of Propofol Against Hemolysis in Patients Submitted to Gastroplasty
Official Title
Protective Effect of Propofol Against Hemolysis in Patients Submitted to Gastroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Unknown status
Study Start Date
November 2008 (undefined)
Primary Completion Date
May 2009 (Anticipated)
Study Completion Date
June 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Centro Medico Campinas

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemolysis
Keywords
Morbid obesity, General anaesthesia, Propofol, Sevoflurane

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
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 Measure Information:
Title
Count erythrocytes
Time Frame
After 10 hours post-surgery
Secondary Outcome Measure Information:
Title
Bilirubins(direct and indirect)
Time Frame
After 10 hours post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ricardo F Simoni, MD
Organizational Affiliation
Fundação Centro Médico de Campinas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fundação Centro Médico de Campinas
City
Campinas
State/Province
São Paulo
ZIP/Postal Code
13084-000
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
11779730
Citation
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. doi: 10.1164/ajrccm.165.1.2010134.
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Protective Effect of Propofol Against Hemolysis in Patients Submitted to Gastroplasty

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