HemolysisNCT00792779
Protective Effect of Propofol Against Hemolysis in Patients Submitted to Gastroplasty
A study testing Propofol in people with Hemolysis, run by Centro Medico Campinas at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hemolysis
- What is being tested?
- Propofol
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2008to Jun 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients between BMI 40-50 kg/m2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Count erythrocytes
Measured: After 10 hours post-surgery
Secondary outcomes (1)
Bilirubins(direct and indirect)
Measured: After 10 hours post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionMay 2009 (estimated)
- Study completionJun 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemolysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Medico Campinas
- Sponsor type
- University, hospital or other
- Investigators
- Ricardo F Simoni, MD, Principal investigator, Fundação Centro Médico de Campinas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00792779
- Sponsor's protocol ID
- CAAE - 0023.0.263.000-08
- Status last verified
- Nov 2009
- First submitted
- 17 Nov 2008
- Last updated
- 5 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1164/ajrccm.165.1.2010134.
PubMed 11779730
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protective Effect of Propofol Against Hemolysis in Patients Submitted to Gastroplasty
- ClinicalTrials.gov ID
- NCT00792779
- Acronym / sponsor ID
- CAAE - 0023.0.263.000-08
- Conditions
- Hemolysis
- Keywords
- Morbid obesity, General anaesthesia, Propofol, Sevoflurane
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centro Medico CampinasUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- May 2009 (estimated)
- Study completion
- Jun 2009 (estimated)
- First posted
- 18 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients between BMI 40-50 kg/m2
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropofolPatients 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. | Drug | – |
Primary outcome
Count erythrocytes
Time frame: After 10 hours post-surgery
1 secondary outcome
Bilirubins(direct and indirect)
Time frame: After 10 hours post-surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2009.
- Results publication: PubMed 11779730Tsuchiya 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricardo F Simoni, MD principal investigator
Fundação Centro Médico de Campinas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol in people with Hemolysis, run by Centro Medico Campinas at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Count erythrocytes (time frame: After 10 hours post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00792779, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2009; AzTrials last refreshed its copy on 7 Nov 2026.