About this trial
The aim of this double-blind randomised study will be to compare a fixed-rate prophylactic metaraminol infusion to a fixed-rate prophylactic norepinephrine infusion during elective cesarean section under combined spinal-epidural anaesthesia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Metaraminol infusion
Procedure/SurgeryIn parturients allocated to the metaraminol group, a metaraminol infusion (30 mL/h corresponding to 100 μg/min) will be initiated as soon as spinal anaesthesia is established.
Norepinephrine infusion
Procedure/SurgeryIn parturients allocated to the norepinephrine group, a norepinephrine infusion (30 mL/h corresponding to 4 μg/min) will be initiated as soon as spinal anaesthesia is established.
Treatment groups
Trial outcomes
Primary outcomes
incidence of hypotension
any occurrence of hypotension throughout the operation will be recorded (SAP \< 80% of baseline)
number of hypotensive episodes in the pregnant woman
the number of hypotensive episodes (SAP \< 80% of baseline)throughout the operation will be recorded
incidence of bradycardia
any incidence of HR \< 60/min will be recorded
Secondary outcomes
need for vasoconstrictor
parturient needed or not vasoconstrictor during the operation
type of bolus vasopressor administered
phenylephrine verus ephedrine
number of bolus doses of vasoconstrictor administered
number of provided interventions to maintain systolic blood pressure within the set limits will be recorded
total dose of vasoconstrictor administered
total dose in mg for ephedrine or μg for phenylephrine
Locations
Sponsors and contacts
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