Phenylephrine Versus Norepinephrine for Maintenance of Hemodynamic During Cesarean Section Under Spinal Anesthesia

Centre Hospitalier Régional d'Orléans124 enrolled

Overview

Comparison between prophylactic continuous variable infusion of phenylephrine (starting dose 0,5mcg/kg/min) and norepinephrine tartrate (starting dose 0,1mcg/kg/min) to prevent hypotension and maintain cardiac output under spinal anesthesia during cesarean delivery.

Maternal hypotension is a frequent complication after spinal anesthesia for cesarean delivery. Many vasopressors have been studied and used, but the perfect vasopressor is yet to be found. Phenylephrine is the most common used in obstetric anesthesia but its cardiac depressant activity, being an only alpha-adrenergic agonistic, is linked to frequent side effects such as bradycardia and decreased cardiac output. Norepinephrine is a vasopressor characterized by both alpha and minor beta-adrenergic agonistic activity, it has then a minimal cardiac depressant activity. Hence it would provide a better stability of hemodynamic and cardiac output, and appears as a better alternative to phenylephrine. In this study, the investigators will compare prophylactic continuous variable infusion of both vasopressors. Phenylephrine started at the dose of 0,5mcg/kg/min and Norepinephrine tartrate started at the dose of 0,1mcg/kg/min. The doses will be adjusted according to maternal systolic blood pressure in order to prevent hypotension (defined by a systolic blood pressure under 80% of baseline).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

124

Conditions

Cesarean Section Complications Spinal Anesthesia

Interventions

NorepinephrineDRUG

Drug: Norepinephrine Norepinephrine tartrate variable infusion with a starting rate of 0,1μg/kg/min (equivalent to norepinephrine base of 0.05 μg /Kg/min). Other name: Noradrenaline Drug: Hyperbaric Bupivacaine will be injected in the subarachnoid space with a dose of 8 to 12 mg adjusted according to height Drug: Sufentanil will be injected in the subarachnoid space with a dose of 2,5μg Drug: Morphine will be injected in the subarachnoid space with a dose of 100 μg

PhenylephrineDRUG

Drug: Phenylephrine variable infusion with a starting rate of 0,5μg/kg/min Drug: Hyperbaric Bupivacaine will be injected in the subarachnoid space with a dose of 8 to 12 mg adjusted according to height Drug: Sufentanil will be injected in the subarachnoid space with a dose of 2,5μg Drug: Morphine will be injected in the subarachnoid space with a dose of 100 μg

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Pregnancy higher than 36 weeks of amenorrhea * Scheduled or semi-urgent (interval between decision and delivery by cesarean section higher than 12hours) cesarean section under spinal anesthesia Exclusion Criteria: * Extreme height (less than 140cm; higher than 180cm) * Weight less than 50kg * Weight higher than 120kg * Cardiovascular disease with use of cardiac medication (including antihypertensive drug) * Active neurological disease * Anti-hypertension treatment. * High blood pressure or severe pre-eclampsia * American Society of Anesthesiologists physical status class higher than 3 * Placenta accrete/percreta * Cesarean section scheduled under general anesthesia * Contraindications to spinal anesthesia * Minor (age less than 18 years old) * Guardianship/ curatorship * Anemia less than or equal to 8 g/dl * Allergy to any study medication * Simultaneous participation in another study

Locations (1)

Regional Hospital Center of ORLEANS

Orléans, France

Outcomes

Primary Outcomes

Cardiac output maintenance (measured in L/min by bioreactance).

Cardiac output values were analyses at eight points * Baseline measurement: patient placed in the supine position with the table tilted 10° left, before spinal anesthesia * Seven measurements at regular intervals: first measurement just after administration of spinal anesthesia in supine position with the table tilted 10° left and last measurement at umbilical cord clamping.

Time frame: 5 minutes before the induction of spinal anesthesia until umbilical cord clamping.

Secondary Outcomes

Heart rate

number of heart beats per minute

Time frame: From induction of spinal anesthesia until weaning of vasopressor

Systolic blood pressure

Systolic blood pressure measured in mmHg

Time frame: From induction of spinal anesthesia until weaning of vasopressor

Mean blood pressure

Mean blood pressure measured in mmHg

Time frame: From induction of spinal anesthesia until weaning of vasopressor

Duration of bradycardia

Cumulative time in minutes with heart rate less than 60 beats/min

Time frame: From induction of spinal anesthesia until weaning of vasopressor]

Duration of hypotension with Mean blood pressure less than 65mmHg

Cumulative time in minutes

Time frame: after applying spinal anesthesia until weaning of vasopressor

Duration of hypotension with Systolic Blood Pressure less than 80mmHg

Cumulative time in minutes

Data from ClinicalTrials.gov

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