Comparison of the Efficacy of Continuous Metaraminol Infusion Versus Continuous Norepinephrine Infusion for the Prevention of Hypotension During Cesarean Section Under Spinal Anaesthesia. A Randomised Controlled Trial.

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-48
SponsorAretaieion University Hospital

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 volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Metaraminol infusion

    Procedure/Surgery

    In 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/Surgery

    In 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

80 Participants
are divided into 2 treatment groups
Group A: Metaraminol groupActive comparator 1 intervention
Group B: Norepinephrine groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

incidence of hypotension

any occurrence of hypotension throughout the operation will be recorded (SAP \< 80% of baseline)

Time frame
intraoperative
2

number of hypotensive episodes in the pregnant woman

the number of hypotensive episodes (SAP \< 80% of baseline)throughout the operation will be recorded

Time frame
intraoperativre
3

incidence of bradycardia

any incidence of HR \< 60/min will be recorded

Time frame
intraoperative

Secondary outcomes

1

need for vasoconstrictor

parturient needed or not vasoconstrictor during the operation

Time frame
intraoperative
2

type of bolus vasopressor administered

phenylephrine verus ephedrine

Time frame
intraoperative
3

number of bolus doses of vasoconstrictor administered

number of provided interventions to maintain systolic blood pressure within the set limits will be recorded

Time frame
intraoperative
4

total dose of vasoconstrictor administered

total dose in mg for ephedrine or μg for phenylephrine

Time frame
intraoperative

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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