Coronary Artery DiseaseNCT05290324
Propofol or Midazolam for Sedation and Early Extubation Following Coronary Artery Bypass Graft Surgery
A study testing Midazolam in people with Coronary Artery Disease, run by Chaudhry Pervaiz Elahi Institute of Cardiology at 1 site in Pakistan.
Trial summary
Propofol and midazolam are used frequently as sedating agents among patients who undergo coronary artery bypass graft surgery but no study in Pakistan has been done to compare their effectiveness aiming early extubation. Read more about this study
- Who is it for?
- Ages 20 to 20 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2019to 1 Feb 2020
- 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 20 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients of American Society of Anesthesiologists (ASA) III who were selected for coronary artery bypass graft surgery.
Who cannot join
- History of any psychiatric disease.
- Using antidepressants
- Alcohol abusers
- Obese
- Pregnant women
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Ch. Pervaiz Elahi Institute of Cardiology
Multan, Punjab Province, 59341
About this study
Propofol and midazolam are used frequently as sedating agents among patients who undergo coronary artery bypass graft surgery but no study in Pakistan has been done to compare their effectiveness aiming early extubation.
Read the detailed description
Propofol is an intra lipid and alkali phenol chemically it is unrelated to sedative agents or anaesthetic. Midazolam is a banzodiazepen. Most of its properties are similar to diazepam. It is a common practice to use sedatives to provide comfort and decrease "ventilator-asynchrony" in critically ill patients that may require prolonged invasive mechanical ventilation. The other reason to employ sedatives is to reduce the anxiety associated with the inaviseve procedures routinely conducted in the ICU.
- Conditions
- Coronary Artery Disease
- Being tested
- Midazolam
- Keywords
- coronary artery bypass graft, midazolam, propofol
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
Also called Versed
Midazolam infusion will be given after the surgery as 0.25 mg/kg/min.
| Study group | Role | What they receive |
|---|---|---|
| MIdazolam Group | Experimental | Following surgery Immediately after shifting in ICU, midazolam infusion were administered as 0.25 mg/kg/min. Receives: Drug: Midazolam |
| Propofol Group | No intervention | Following surgery after Immediately shifting in ICU propofol infusion was started at 10µg/kg/min. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of post-surgery sedation
Duration of post-surgery sedation following cardiac surgery
Measured: Time in minutes calculated from end of surgery to the time of awakening up to 24 hours in both study groups
Time taken to post-surgery extubation
Time taken from the end of cardiac surgery to post-surgery extubation
Measured: Time taken in minutes from the end of the cardiac surgery to post-surgery extubation up to 1 week duration in both study groups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start1 Feb 2019
- Primary completion1 Feb 2020
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Model description
- Radomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chaudhry Pervaiz Elahi Institute of Cardiology
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Shumaila rai, Chaudhry Pervaiz Elahi Institute of Cardiology
- Investigators
- Shumaila Rai, MBBS, Principal investigator, Ch. Pervaiz Elahi Institute of Cardiology, Multan, Pakisan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05290324
- Sponsor's protocol ID
- CPEIC22
- Status last verified
- Mar 2022
- First submitted
- 30 Jan 2022
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Propofol or Midazolam for Sedation and Early Extubation Following Coronary Artery Bypass Graft Surgery
- ClinicalTrials.gov ID
- NCT05290324
- Acronym / sponsor ID
- CPEIC22
- Conditions
- Coronary Artery Disease
- Keywords
- coronary artery bypass graft, midazolam, propofol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chaudhry Pervaiz Elahi Institute of CardiologyOther government
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 22 Mar 2022 (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.
Propofol and midazolam are used frequently as sedating agents among patients who undergo coronary artery bypass graft surgery but no study in Pakistan has been done to compare their effectiveness aiming early extubation.
Detailed description
Propofol is an intra lipid and alkali phenol chemically it is unrelated to sedative agents or anaesthetic. Midazolam is a banzodiazepen. Most of its properties are similar to diazepam. It is a common practice to use sedatives to provide comfort and decrease "ventilator-asynchrony" in critically ill patients that may require prolonged invasive mechanical ventilation. The other reason to employ sedatives is to reduce the anxiety associated with the inaviseve procedures routinely conducted in the ICU.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Radomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| MIdazolam Group | Experimental | Drug: MidazolamFollowing surgery Immediately after shifting in ICU, midazolam infusion were administered as 0.25 mg/kg/min. |
| Propofol Group | No intervention | –Following surgery after Immediately shifting in ICU propofol infusion was started at 10µg/kg/min. |
Who may qualify
- Ages
- 20 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients of American Society of Anesthesiologists (ASA) III who were selected for coronary artery bypass graft surgery.
Key exclusion criteria (5 listed)
- History of any psychiatric disease.
- Using antidepressants
- Alcohol abusers
- Obese
- Pregnant women
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 |
|---|---|---|
| MidazolamAlso: VersedMidazolam infusion will be given after the surgery as 0.25 mg/kg/min. | Drug | MIdazolam Group |
Primary outcome
Duration of post-surgery sedation
Time frame: Time in minutes calculated from end of surgery to the time of awakening up to 24 hours in both study groups
Duration of post-surgery sedation following cardiac surgery
Time taken to post-surgery extubation
Time frame: Time taken in minutes from the end of the cardiac surgery to post-surgery extubation up to 1 week duration in both study groups
Time taken from the end of cardiac surgery to post-surgery extubation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- Individual participant dataSharing planned: No
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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.
Shumaila Rai, MBBS principal investigator
Ch. Pervaiz Elahi Institute of Cardiology, Multan, Pakisan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Midazolam in people with Coronary Artery Disease, 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 5 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: finished, as of the sponsor's last update on 22 Mar 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Duration of post-surgery sedation (time frame: Time in minutes calculated from end of surgery to the time of awakening up to 24 hours in both study groups). The study lists 2 primary outcomes in all. 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 22 Mar 2022.