Cardiovascular Surgical ProcedureNCT03233815
Benefits of Total Intravenous Anesthesia Compared With Inhaled Anesthesia in Cardiovascular Surgery
An observational study of Cardiovascular Surgical Procedure, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
Trial summary
This study compares the difference in proinflammatory markers Interleukin 6 (IL-6), Tumor necrosis factor alpha (TNFα) and cortisol in patients undergoing cardiovascular surgery to asses if there is a benefit of using intravenous total anesthesia (TIVA) over inhaled anesthesia for this procedures. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Cardiovascular Surgical Procedure
- What is being tested?
- Propofol and Sevoflurane
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- 1 siteMexico
- Study dates
- 13 Nov 2017to Dec 2021
- Phase
- Observational
- 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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients scheduled for cardiovascular surgery
Who may be able to join
- Scheduled for cardiovascular surgery American Society of Anaesthesiologists (ASA) physical status classification II-IV BMI < 25 HbA1c < 7%
Who cannot join
- Diabetic patients Known allergy to propofol
Trial locations and contacts
1 site in 1 country.
About this study
This study compares the difference in proinflammatory markers Interleukin 6 (IL-6), Tumor necrosis factor alpha (TNFα) and cortisol in patients undergoing cardiovascular surgery to asses if there is a benefit of using intravenous total anesthesia (TIVA) over inhaled anesthesia for this procedures.
Read the detailed description
IL-6, TNFα and cortisol will be measure at the beginning of the cardiovascular surgery and 20 minutes after the cardiovascular bypass ends to calculate the difference between them and compare if there is any statistical difference between the proinflammatory markers with the two anesthesia techniques.
- Conditions
- Cardiovascular Surgical Procedure
- Being tested
- Propofol, Sevoflurane
- Keywords
- Inhaled anesthesia, Total intravenous anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Also called Diprivan
Propofol anesthesia Dose: 4-6mg/kg/h
SevofluraneDrug
Also called Sevorane
Inhaled anesthesia with sevoflurane. Dose: 1-2.5 Minimum Alveolar Concentration(MAC)
| Study group | Role | What they receive |
|---|---|---|
| Inhaled anesthesia (Sevoflurane) | Patients undergoing cardiovascular surgery with inhaled anesthesia with sevoflurane. Receives: Drug: Sevoflurane | |
| Total Intravenous Anesthesia (Propofol) | Patients undergoing cardiovascular surgery with total intravenous anesthesia with propofol. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
IL-6
IL-6 will be compared between the groups.
Measured: The difference between IL-6 at the begging of surgery and 20 minutes after the end of the cardiopulmonary bypass
Secondary outcomes (2)
TNFα
TNFα will be compared between the groups
Measured: The difference between TNFα at the begging of surgery and 20 minutes after the end of the cardiopulmonary bypass
Cortisol
Cortisol will be compared between the groups
Measured: The difference between cortisol at the begging of surgery and 20 minutes after the end of the cardiopulmonary bypass
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2017
- Study start13 Nov 2017
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Surgical ProcedureStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Coordinación de Investigación en Salud, Mexico
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ana Gallardo, PhD, Principal investigator, Instituto Mexicano del Seguroa Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03233815
- Sponsor's protocol ID
- R-2017-3604-95
- Status last verified
- Aug 2020
- First submitted
- 26 Jul 2017
- Last updated
- 6 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The plan is not decided yet.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of Total Intravenous Anesthesia Compared With Inhaled Anesthesia in Cardiovascular Surgery
- ClinicalTrials.gov ID
- NCT03233815
- Acronym / sponsor ID
- R-2017-3604-95
- Conditions
- Cardiovascular Surgical Procedure
- Keywords
- Inhaled anesthesia, Total intravenous anesthesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Coordinación de Investigación en Salud, MexicoOther government
- Study start
- 13 Nov 2017 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 31 Jul 2017 (actual)
- 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.
This study compares the difference in proinflammatory markers Interleukin 6 (IL-6), Tumor necrosis factor alpha (TNFα) and cortisol in patients undergoing cardiovascular surgery to asses if there is a benefit of using intravenous total anesthesia (TIVA) over inhaled anesthesia for this procedures.
Detailed description
IL-6, TNFα and cortisol will be measure at the beginning of the cardiovascular surgery and 20 minutes after the cardiovascular bypass ends to calculate the difference between them and compare if there is any statistical difference between the proinflammatory markers with the two anesthesia techniques.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inhaled anesthesia (Sevoflurane) | – | Drug: SevofluranePatients undergoing cardiovascular surgery with inhaled anesthesia with sevoflurane. |
| Total Intravenous Anesthesia (Propofol) | – | Drug: PropofolPatients undergoing cardiovascular surgery with total intravenous anesthesia with propofol. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients scheduled for cardiovascular surgery
Key inclusion criteria (1 listed)
- Scheduled for cardiovascular surgery American Society of Anaesthesiologists (ASA) physical status classification II-IV BMI < 25 HbA1c < 7%
Key exclusion criteria (1 listed)
- Diabetic patients Known allergy to propofol
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 |
|---|---|---|
| PropofolAlso: DiprivanPropofol anesthesia Dose: 4-6mg/kg/h | Drug | Total Intravenous Anesthesia (Propofol) |
| SevofluraneAlso: SevoraneInhaled anesthesia with sevoflurane. Dose: 1-2.5 Minimum Alveolar Concentration(MAC) | Drug | Inhaled anesthesia (Sevoflurane) |
Primary outcome
IL-6
Time frame: The difference between IL-6 at the begging of surgery and 20 minutes after the end of the cardiopulmonary bypass
IL-6 will be compared between the groups.
2 secondary outcomes
TNFα
Time frame: The difference between TNFα at the begging of surgery and 20 minutes after the end of the cardiopulmonary bypass
Cortisol
Time frame: The difference between cortisol at the begging of surgery and 20 minutes after the end of the cardiopulmonary bypass
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2020.
- Individual participant dataSharing planned: Undecided. The plan is not decided yet.
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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.
Ana Gallardo, PhD principal investigator
Instituto Mexicano del Seguroa Social
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Surgical Procedure, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
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 1 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 6 Aug 2020. 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 Mexico. 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?
IL-6 (time frame: The difference between IL-6 at the begging of surgery and 20 minutes after the end of the cardiopulmonary bypass). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Aug 2020.