Protective Effect of Propofol Against Hemolysis in Patients Submitted to Gastroplasty

NCT ID: NCT00792779

Last Updated: 2009-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2009-06-30

Brief Summary

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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

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Conditions

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Hemolysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centro Medico Campinas

OTHER

Sponsor Role lead

Responsible Party

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Fundação Centro Médico de Campinas

Principal Investigators

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Ricardo F Simoni, MD

Role: PRINCIPAL_INVESTIGATOR

Fundação Centro Médico de Campinas

Locations

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Fundação Centro Médico de Campinas

Campinas, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type RESULT
PMID: 11779730 (View on PubMed)

Other Identifiers

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CAAE - 0023.0.263.000-08

Identifier Type: -

Identifier Source: org_study_id

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