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Hypotension on InductionPhase 4NCT04291794

Mean Arterial Pressure Reduction Anesthesia Induction Using Propofol Bolus or Tritiated Target-infusion

A Phase 4 study testing Propofol and Propofol Injection [Diprivan] in people with Hypotension on Induction and Hypnotic Intoxication, run by Brasilia University Hospital at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To compare haemodynamics and bispectral index values between conventional bolus propofol induction and target-controlled propofol infusion. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
What is being tested?
Propofol and Propofol Injection [Diprivan]
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteBrazil
Study dates
1 Mar 2020to 27 Nov 2020
Phase
Phase 4
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Scheduled for general anesthesia;
  • No contraindication for propofol.

Who cannot join

  • Data loss;
  • Protocol violation.

Trial locations and contacts

1 site in 1 country.

Gabriel MN Guimaraes, MSc contact

+5561996455997

gabrielmng@gmail.com

Brazil1 site

  • Hospital Universitário de Brasilia

    Brasília, Federal District, 70000000

Other trials in Brazil

About this study

Official title: Mean Arterial Pressure Reduction During the First Ten Minutes After General Anesthesia Induction Using Propofol Bolus or Tritiated Target-infusion: Superiority Randomized Controlled Trial

To compare haemodynamics and bispectral index values between conventional bolus propofol induction and target-controlled propofol infusion.

Read the detailed description

To compare mean arterial pressure, heart rate and bispectral index values between conventional bolus propofol induction and target-controlled propofol infusion.

Being tested
Propofol, Propofol Injection [Diprivan]

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PropofolDrug

    2mg/kg single bolus

  • Propofol Injection [Diprivan]Drug

    Tritiated Target-Controlled Infusion

Study groups in NCT04291794
Study groupRoleWhat they receive
Conventional bolus inductionActive comparatorHypnotic component of general anesthesia induction will be a single bolus of propofol 2mg/kg followed by turning on sevoflurane 2% at a fresh gas flow of 2L/min.
Receives: Drug: Propofol
Target-controlled inductionExperimentalHypnotic component of general anesthesia induction will be target-controlled propofol infusion tritiated to loss of consciousness. Propofol target-controlled infusion will be maintained.
Receives: Drug: Propofol Injection [Diprivan]

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean arterial pressure after 2 minutes

    Mean arterial pressure using non-invasive device

    Measured: 2 minutes after general anesthesia induction

  2. Mean arterial pressure after 4 minutes

    Mean arterial pressure using non-invasive device

    Measured: 4 minutes after general anesthesia induction minutes after general anesthesia induction

  3. Mean arterial pressure after 6 minutes

    Mean arterial pressure using non-invasive device

    Measured: 6 minutes after general anesthesia induction minutes after general anesthesia induction

  4. Mean arterial pressure after 8 minutes

    Mean arterial pressure using non-invasive device

    Measured: 8 minutes after general anesthesia induction minutes after general anesthesia induction

  5. Mean arterial pressure after 10 minutes

    Mean arterial pressure using non-invasive device

    Measured: 10 minutes after general anesthesia induction minutes after general anesthesia induction

Secondary outcomes (10)

  1. Heart Rate after 2 minutes

    Heart rate (pulse rate) using non-invasive device.

    Measured: 2 minutes after general anesthesia induction

  2. Heart Rate after 4 minutes

    Heart rate (pulse rate) using non-invasive device.

    Measured: 4 minutes after general anesthesia induction

  3. Heart Rate after 6 minutes

    Heart rate (pulse rate) using non-invasive device.

    Measured: 6 minutes after general anesthesia induction

  4. Heart Rate after 8 minutes

    Heart rate (pulse rate) using non-invasive device.

    Measured: 8 minutes after general anesthesia induction

  5. Heart Rate after 10 minutes

    Heart rate (pulse rate) using non-invasive device.

    Measured: 10 minutes after general anesthesia induction

  6. Bispectral Index after 2 minutes

    Bispectral Index (BIS) using non-invasive device. At values near 100 mean patient is more likely to be awake and at values below 60 are more likely to be under general anesthesia.

    Measured: 2 minutes after general anesthesia induction

  7. Bispectral Index after 4 minutes

    Bispectral Index (BIS) using non-invasive device. At values near 100 mean patient is more likely to be awake and at values below 60 are more likely to be under general anesthesia.

    Measured: 4 minutes after general anesthesia induction

  8. Bispectral Index after 6 minutes

    Bispectral Index (BIS) using non-invasive device. At values near 100 mean patient is more likely to be awake and at values below 60 are more likely to be under general anesthesia.

    Measured: 6 minutes after general anesthesia induction

  9. Bispectral Index after 8 minutes

    Bispectral Index (BIS) using non-invasive device. At values near 100 mean patient is more likely to be awake and at values below 60 are more likely to be under general anesthesia.

    Measured: 8 minutes after general anesthesia induction

  10. Bispectral Index after 10 minutes

    Bispectral Index (BIS) using non-invasive device. At values near 100 mean patient is more likely to be awake and at values below 60 are more likely to be under general anesthesia.

    Measured: 10 minutes after general anesthesia induction

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2020
  2. Study start1 Mar 2020 (estimated)
  3. Primary completion25 Sep 2020 (estimated)
  4. Study completion27 Nov 2020 (estimated)

Resources

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 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04291794
Sponsor's protocol ID
tccgui2019
Status last verified
Feb 2020
First submitted
26 Feb 2020
Last updated
2 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Plan to share at open database.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Propofol and Propofol Injection [Diprivan] in people with Hypotension on Induction and Hypnotic Intoxication, run by Brasilia University Hospital 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 2 inclusion and 2 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 2 Mar 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 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Gabriel MN Guimaraes, MSc (+5561996455997, gabrielmng@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean arterial pressure after 2 minutes (time frame: 2 minutes after general anesthesia induction). The study lists 5 primary outcomes in all. 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 NCT04291794.

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 2 Mar 2020.

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