A Phase 4 interventional study of Propofol and Propofol Injection [Diprivan] in Hypotension on Induction and Hypnotic Intoxication, sponsored by Brasilia University Hospital. Status unknown at 1 site in Brazil. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-02.
Sponsored by Brasilia University Hospital · Phase 4, Interventional, and Prevention
To compare haemodynamics and bispectral index values between conventional bolus propofol induction and target-controlled propofol infusion.
To compare mean arterial pressure, heart rate and bispectral index values between conventional bolus propofol induction and target-controlled propofol infusion.
885 studies on the registry are indexed under Hypotension; 195 are open to participants now.
This study's planned enrollment of 120 is above the median of 87 across 590 interventional studies indexed under Hypotension.
Browse Hypotension studies →Brasilia University Hospital is the lead sponsor of 20 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypnotic 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.
Drug: Propofol
Hypnotic component of general anesthesia induction will be target-controlled propofol infusion tritiated to loss of consciousness. Propofol target-controlled infusion will be maintained.
Drug: Propofol Injection [Diprivan]
2mg/kg single bolus
Tritiated Target-Controlled Infusion
Mean arterial pressure after 2 minutes
Mean arterial pressure using non-invasive device
Time frame: 2 minutes after general anesthesia induction
Mean arterial pressure after 4 minutes
Mean arterial pressure using non-invasive device
Time frame: 4 minutes after general anesthesia induction minutes after general anesthesia induction
Mean arterial pressure after 6 minutes
Mean arterial pressure using non-invasive device
Time frame: 6 minutes after general anesthesia induction minutes after general anesthesia induction
Mean arterial pressure after 8 minutes
Mean arterial pressure using non-invasive device
Time frame: 8 minutes after general anesthesia induction minutes after general anesthesia induction
Mean arterial pressure after 10 minutes
Mean arterial pressure using non-invasive device
Time frame: 10 minutes after general anesthesia induction minutes after general anesthesia induction
Heart Rate after 2 minutes
Heart rate (pulse rate) using non-invasive device.
Time frame: 2 minutes after general anesthesia induction
Heart Rate after 4 minutes
Heart rate (pulse rate) using non-invasive device.
Time frame: 4 minutes after general anesthesia induction
Heart Rate after 6 minutes
Heart rate (pulse rate) using non-invasive device.
Time frame: 6 minutes after general anesthesia induction
Heart Rate after 8 minutes
Heart rate (pulse rate) using non-invasive device.
Time frame: 8 minutes after general anesthesia induction
Heart Rate after 10 minutes
Heart rate (pulse rate) using non-invasive device.
Time frame: 10 minutes after general anesthesia induction
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.
Time frame: 2 minutes after general anesthesia induction
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.
Time frame: 4 minutes after general anesthesia induction
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.
Time frame: 6 minutes after general anesthesia induction
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.
Time frame: 8 minutes after general anesthesia induction
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.
Time frame: 10 minutes after general anesthesia induction
Plan to share: Yes — Plan to share at open database.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: After study ends
Access criteria: Open
No publications or documents are linked to this record.
Start is estimated for Mar 2020; primary completion for Sep 2020, 6 months later.
Of 60 non-industry phase 4 interventional studies under Hypotension, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 20. This study's planned 6 months is below that.
Counting every sponsor, half of 61 studies reached it within 12 months; a quarter within 5 and three quarters within 20.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Propofol
Brasilia University Hospital