Hemodynamic InstabilityNCT05004545
Compare Hemodynamic Parameters of Propofol and Sevoflurane During CPB Time in Undergoing CABG to Avoid Lactate Level
A study testing Propofol in people with Hemodynamic Instability, run by Chaudhry Pervaiz Elahi Institute of Cardiology at 1 site in Pakistan.
Trial summary
Hemodynamic parameters and lactate level will be on CBP during CABG surgery patients. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Hemodynamic Instability
- What is being tested?
- Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Jun 2017to 30 Dec 2021
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- CABG
Who cannot join
- Emergency surgery
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Cardiac Surgery ICU
Multan, Punjab Province, 66100
Kneez Ume Farwa, FCPS
Kaneez Ume Farwa, FCPS
About this study
Official title: To Compare Hemodynamic Parameters of Propofol and Sevoflurane During Cardiopulmonary Bypass Time in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery to Avoid Lactate Level.
Hemodynamic parameters and lactate level will be on CBP during CABG surgery patients.
Read the detailed description
Objective: To compare hemodynamic parameters of propofol and sevoflurane during cardiopulmonary bypass time in patients undergoing coronary artery bypass graft (CABG) surgery to avoid lactate level.
Methods: One hundred and twenty six patients scheduled for CABG from May 2017 to May 2018 will be included in this study. Non probability consecutive sampling will be used. Patients will be divided in two groups, propofol will be given to group 1, and sevoflurane will be given to group 2. Age, clamp time, bypass time, mean arterial blood pressure on bypass machine and lactate level will be compared between two groups. SPSS version 24 will used and p value ≤ 0.05 will be considered as significant.
- Conditions
- Hemodynamic Instability
- Being tested
- Propofol
- Keywords
- Propofol, Sevoflurane, hemodynamic stability, Lactate level
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Propofol infusion according to body weight will be compared with sevoflurane acording to MAC % to see the lactate level and hemodynamic parameters of CABG patients
| Study group | Role | What they receive |
|---|---|---|
| group 1 Profol Infusion to CABG patients to check lactate level | Experimental | Propofol infusion according to bodyweight will be given to check lactate level on CPB Receives: Drug: Propofol |
| sevoflurane will be given to group 2 to check lacate level | Active comparator | Sevoflurane MAC % will be given to CABG patients to check lactate level Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lactate level will be measured during CPB for CABG patients to see the hemodynamics parameters
The mean pre-cross clamp lactate level and post- rewarming lactate level will be calculated to see the effect of this on the CABG patients hemodynamics during CBP
Measured: 06 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start10 Jun 2017
- Primary completion20 Sep 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic InstabilityStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chaudhry Pervaiz Elahi Institute of Cardiology
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Muhammad Imran Khan, Chaudhry Pervaiz Elahi Institute of Cardiology
- Investigators
- Kaneez Ume Farwa, FCPS, Principal investigator, Chaudhry Pervaiz Elahi Institute of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05004545
- Sponsor's protocol ID
- CPEIC-06
- Status last verified
- Aug 2021
- First submitted
- 16 Jul 2021
- Last updated
- 13 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Ok
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Compare Hemodynamic Parameters of Propofol and Sevoflurane During Cardiopulmonary Bypass Time in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery to Avoid Lactate Level.
- ClinicalTrials.gov ID
- NCT05004545
- Acronym / sponsor ID
- CPEIC-06
- Conditions
- Hemodynamic Instability
- Keywords
- Propofol, Sevoflurane, hemodynamic stability, Lactate level
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Chaudhry Pervaiz Elahi Institute of CardiologyOther government
- Study start
- 10 Jun 2017 (actual)
- Primary completion
- 20 Sep 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 13 Aug 2021 (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.
Hemodynamic parameters and lactate level will be on CBP during CABG surgery patients.
Detailed description
Objective: To compare hemodynamic parameters of propofol and sevoflurane during cardiopulmonary bypass time in patients undergoing coronary artery bypass graft (CABG) surgery to avoid lactate level.
Methods: One hundred and twenty six patients scheduled for CABG from May 2017 to May 2018 will be included in this study. Non probability consecutive sampling will be used. Patients will be divided in two groups, propofol will be given to group 1, and sevoflurane will be given to group 2. Age, clamp time, bypass time, mean arterial blood pressure on bypass machine and lactate level will be compared between two groups. SPSS version 24 will used and p value ≤ 0.05 will be considered as significant.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 Profol Infusion to CABG patients to check lactate level | Experimental | Drug: PropofolPropofol infusion according to bodyweight will be given to check lactate level on CPB |
| sevoflurane will be given to group 2 to check lacate level | Active comparator | Drug: PropofolSevoflurane MAC % will be given to CABG patients to check lactate level |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- CABG
Key exclusion criteria (1 listed)
- Emergency surgery
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 |
|---|---|---|
| PropofolPropofol infusion according to body weight will be compared with sevoflurane acording to MAC % to see the lactate level and hemodynamic parameters of CABG patients | Drug | group 1 Profol Infusion to CABG patients to check lactate level, sevoflurane will be given to group 2 to check lacate level |
Primary outcome
Lactate level will be measured during CPB for CABG patients to see the hemodynamics parameters
Time frame: 06 months
The mean pre-cross clamp lactate level and post- rewarming lactate level will be calculated to see the effect of this on the CABG patients hemodynamics during CBP
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2021.
- Individual participant dataSharing planned: Yes. Ok
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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.
Kaneez Ume Farwa, FCPS principal investigator
Chaudhry Pervaiz Elahi Institute of Cardiology
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 Hemodynamic Instability, run by Chaudhry Pervaiz Elahi Institute of Cardiology at 1 site in Pakistan.
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 13 Aug 2021. 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 Pakistan. 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?
Contact Kaneez Ume Farwa, FCPS (+923356787214, farwatirmizi@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lactate level will be measured during CPB for CABG patients to see the hemodynamics parameters (time frame: 06 months). 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 13 Aug 2021.