Protective Effect of Propofol Against Hemolysis in Patients Submitted to Gastroplasty
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2008
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 17, 2008
CompletedFirst Posted
Study publicly available on registry
November 18, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedNovember 5, 2009
November 1, 2009
6 months
November 17, 2008
November 4, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Count erythrocytes
After 10 hours post-surgery
Secondary Outcomes (1)
Bilirubins(direct and indirect)
After 10 hours post-surgery
Interventions
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 Criteria
You may qualify if:
- patients between BMI 40-50 kg/m2
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fundação Centro Médico de Campinas
Campinas, São Paulo, 13084-000, Brazil
Related 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. doi: 10.1164/ajrccm.165.1.2010134.
PMID: 11779730RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ricardo F Simoni, MD
Fundação Centro Médico de Campinas
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 17, 2008
First Posted
November 18, 2008
Study Start
November 1, 2008
Primary Completion
May 1, 2009
Study Completion
June 1, 2009
Last Updated
November 5, 2009
Record last verified: 2009-11