Protective Effect of Propofol Against Hemolysis in Patients Submitted to Gastroplasty

Hemolysis Clinical Trial

Official title:

Protective Effect of Propofol Against Hemolysis in Patients Submitted to Gastroplasty

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00792779
• Other study ID #: CAAE - 0023.0.263.000-08
• Status: Active, not recruiting
• Phase: N/A
• First received: November 17, 2008
• Last updated: November 4, 2009
• Start date: November 2008
• Est. completion date: June 2009

Study information

• Verified date: November 2009
• Source: Centro Medico Campinas
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: June 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemolysis

Intervention

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 ?g.ml-1, respectively. The patients in the Sevoflurane Group (SG) will be induced with remifentanil TCI at target dose of 8.0 ?g.ml-1 and etomidate 0.5 mg.kg-1 in bolus.

Locations

Country	Name	City	State
Brazil	Fundação Centro Médico de Campinas	Campinas	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Centro Medico Campinas

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Count erythrocytes		After 10 hours post-surgery	Yes
Secondary	Bilirubins(direct and indirect)		After 10 hours post-surgery	Yes