A Phase 3 interventional study of Ephedrine and Norepinephrine in Hypotension on Induction, sponsored by Brugmann University Hospital. Status unknown at 1 site in Belgium. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-09-16.
Sponsored by Brugmann University Hospital · Phase 3, Interventional, and Treatment
Hypotension occurs frequently after anesthesia induction and is more frequent in patients with chronic renal insufficiency. This hypotension occurs most frequently during the 20 minutes after anesthesia induction. Hypotension is commonly corrected by ephedrine bolus injection. However, presynaptic noradrenaline reserve may be lower in patients with chronic renal insufficiency rendering this treatment less effective. Another drug commonly used is norepinephrine, which action is independent of presynaptic noradrenaline storage.
The primary hypothesis is that in patients with chronic renal insufficiency, bolus injection of norepinephrine will be more effective then ephedrine injections to correct hypotension after anesthesia induction.
60 patients with a glomerular filtration rate less than 45 mL/min/m2 (KDIGO classification less than grade 3b) will be included in this prospective double blind trial. All patients will be anesthetized by target-controlled infusion of propofol adjusted to a patient state index (Measured by Sedline, Masimo) of 25-50. Sufentanil injection will be based on noxious stimuli according to the attending anesthesiologist's judgement.
Non-invasive blood pressure will be measured at the pre-anesthesia clinic, before induction and every minute up to 20 minutes post anesthesia induction. Episodes of hypotension, defined as a mean arterial blood pressure less than 65 mm Hg, will be treated either by a bolus injection of 6 mg ephedrine or a bolus injection of 6 mcg norepinephrine, which are equipotent doses. Seringues containing either ephedrine 3 mg/mL or norepinephrine 3 mcg/mL will be prepared by an anesthesia nurse not involved in the care of the patient and labeled as "VASO-IRC-inclusion number". Randomization will be done by a computer generated list in a block randomization of 5.
Primary outcome is the number of boluses needed to maintain arterial blood pressure above a mean of 65 mm Hg.
1,003 studies on the registry are indexed under Hypotension; 173 are open to participants now.
This study's planned enrollment of 60 is below the median of 80 across 675 interventional studies indexed under Hypotension.
Browse Hypotension studies →Brugmann University Hospital is the lead sponsor of 116 studies on the registry; 17 are open to participants now.
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Exclusion Criteria:
In this group, any hypotension less than 65 mm Hg will be corrected by bolus injection of 6 mg ephedrine. Bolus injection will be repeated every 3 minutes, as needed, to keep mean arterial pressure above 65 mm Hg.
Drug: Ephedrine
In this group, any hypotension less than 65 mm Hg will be corrected by bolus injection of 6 mcg norepinephrine. Bolus injection will be repeated every 3 minutes, as needed, to keep mean arterial pressure above 65 mm Hg.
Drug: Norepinephrine
Bolus injection of 6 mg ephedrine to keep mean arterial blood pressure above 65 mm Hg
Bolus injection of either 6 mcg norepinephrine to keep mean arterial blood pressure above 65 mm Hg
Number of boluses
Primary outcome is the number of boluses of either ephedrine or norepinephrine needed to keep mean arterial blood pressure above 65 mm Hg
Time frame: 20 minutes after anesthesia induction
Plan to share: No
This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Brugmann University Hospital