Comparison of phenylephrine versus norepinephrine for maintenance of hemodynamic during cesarean section under spinal anesthesia.

Randomized, double-blind, controlled clinical trial for comparison of continuous phenylephrine versus norepinephrine infusion for maintenance of hemodynamic stability during cesarean section under spinal anesthesia - PHENAD

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-003182-34-FR

Enrollment

124

Registered

2018-08-30

Start date

2018-10-18

Completion date

Unknown

Last updated

2021-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hypotension during caesarean section under spinal anesthesia

Interventions

Trade Name: Noradrenaline MYLAN Product Name: NORADRENALINE Pharmaceutical Form: Solution for infusion in administration system Trade Name: Phényléphrine RENAUDIN Product Name: Phényléphrine Pharmace

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Pregnancy > 36 weeks of amenorrhea -Scheduled or semi-urgent (interval between decision and delivery by caesarean section >12hours) caesarean section under spinal anesthesia Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 124 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: -Extreme size ( 180cm) -Weight less than 50kg - body mass index (BMI) >40 kg/m2 -Cardiovascular disease with use of cardiac medication -Active neurological disease. -antihypertensive drug. -severe pre-eclampsia -American Society of Anesthesiologists physical status class >3 -Placenta accreta / percreta -Cesarean section scheduled under general anesthesia. -Contraindications to spinal anesthesia -age less than 18 years -guardianship, curatorship -Anemia <= 8g / dl -allergy to any study medication -simultaneous participation in another study

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary aim of this study is to compare prophylactic intravenous infusions of phenylephrine and noradrenaline for maintenance of cardiac output during cesarean delivery under spinal anesthesia;Secondary Objective: The secondary objectives of this study are to compare effects of norepinephrine and phenylephrine in: -Maternal hemodynamic parameters (other than cardiac output) -bolus administrations of vasopressor and atropine -neonatal vitality assessment -maternal safety of experimental drugs -utero-placental perfusion -maternal blood glucose concentration -blood glucose concentration in the newborn. ;Primary end point(s): cardiac output (show a 12% higher cardiac output in noradrenaline versus phenylephrine group).;Timepoint(s) of evaluation of this end point: Cardiac output values were analyzed at eight points : -Baseline measurement : patient placed in the supine position with the table tilted 15° left, before spinal anesthesia. -7 measurements at regular intervals : first mesurement just after spinal anesthesia administration in supine position with the table tilted 15° left and last measurement at umbilical cord clamping.	—

Measure

Time frame

Main Objective: The primary aim of this study is to compare prophylactic intravenous infusions of phenylephrine and noradrenaline for maintenance of cardiac output during cesarean delivery under spinal anesthesia;Secondary Objective: The secondary objectives of this study are to compare effects of norepinephrine and phenylephrine in: -Maternal hemodynamic parameters (other than cardiac output) -bolus administrations of vasopressor and atropine -neonatal vitality assessment -maternal safety of experimental drugs -utero-placental perfusion -maternal blood glucose concentration -blood glucose concentration in the newborn. ;Primary end point(s): cardiac output (show a 12% higher cardiac output in noradrenaline versus phenylephrine group).;Timepoint(s) of evaluation of this end point: Cardiac output values were analyzed at eight points : -Baseline measurement : patient placed in the supine position with the table tilted 15° left, before spinal anesthesia. -7 measurements at regular intervals : first mesurement just after spinal anesthesia administration in supine position with the table tilted 15° left and last measurement at umbilical cord clamping.

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Secondary

Measure	Time frame
Secondary end point(s): -Duration of the bradycardia with Heart Rate <60 beats / minute -Mean blood pressure (MBP) -Duration of hypotension (cumulative time) with MBP <65mmhg) -Duration of hypotension (cumulative time) with systolic blood pressure <80mmhg) -Systolic Blood Pressure (SBP) in mmHg) -Stroke volume -Systemic Vascular Resistance -Maximum flow rate of noradrenaline and phenyleprine (ml / h) -Quantity of noradrenaline and phenyleprine administered (mg) -Quantity of corrective bolus: atropine, ephedrine (mg) and other vasopressor agent administered -Incidence of at least one episode of Nausea or vomiting -Incidence of at least one episode of dizziness or malaise -Maternal blood glucose level -Fetal well-being parameters: pH, lactate, PO2, PCO2, Base excess and glucose from umbilical artery cord blood sample. Apgar at 1min-3min-5min-10min. Capillary blood glucose measurement at 1 hour after birth. -Uterine and umbilical arteries doppler with measurement of the Pulsatility Index (PI) just before the realization of spinal anesthesia and 5 min after induction of spinal anesthesia. ;Timepoint(s) of evaluation of this end point: -Maternal blood glucose measurements at peripheral intravenous line placement and umbilical cord clamping -Fetal well-being parameters: pH, lactate, PO2, PCO2, Base excess and glucose from umbilical artery cord blood sample. Apgar at 1min-3min-5min-10min. Capillary blood glucose measurement at 1 hour after birth. -Uterine and umbilical arteries doppler with measurement of the Pulsatility Index (PI) just before the realization of spinal anesthesia and 5 min after induction of spinal anesthesia. -hemodynamic monitoring: measurement frequency, every 1 minute from induction of spinal anesthesia until umbilical cord clamping and after every 3 minutes until weaning of vasopressor -others Secondary end points : data collection from spinal anesthesia induction until weaning of vasopressor	—

Measure

Time frame

Secondary end point(s): -Duration of the bradycardia with Heart Rate <60 beats / minute -Mean blood pressure (MBP) -Duration of hypotension (cumulative time) with MBP <65mmhg) -Duration of hypotension (cumulative time) with systolic blood pressure <80mmhg) -Systolic Blood Pressure (SBP) in mmHg) -Stroke volume -Systemic Vascular Resistance -Maximum flow rate of noradrenaline and phenyleprine (ml / h) -Quantity of noradrenaline and phenyleprine administered (mg) -Quantity of corrective bolus: atropine, ephedrine (mg) and other vasopressor agent administered -Incidence of at least one episode of Nausea or vomiting -Incidence of at least one episode of dizziness or malaise -Maternal blood glucose level -Fetal well-being parameters: pH, lactate, PO2, PCO2, Base excess and glucose from umbilical artery cord blood sample. Apgar at 1min-3min-5min-10min. Capillary blood glucose measurement at 1 hour after birth. -Uterine and umbilical arteries doppler with measurement of the Pulsatility Index (PI) just before the realization of spinal anesthesia and 5 min after induction of spinal anesthesia. ;Timepoint(s) of evaluation of this end point: -Maternal blood glucose measurements at peripheral intravenous line placement and umbilical cord clamping -Fetal well-being parameters: pH, lactate, PO2, PCO2, Base excess and glucose from umbilical artery cord blood sample. Apgar at 1min-3min-5min-10min. Capillary blood glucose measurement at 1 hour after birth. -Uterine and umbilical arteries doppler with measurement of the Pulsatility Index (PI) just before the realization of spinal anesthesia and 5 min after induction of spinal anesthesia. -hemodynamic monitoring: measurement frequency, every 1 minute from induction of spinal anesthesia until umbilical cord clamping and after every 3 minutes until weaning of vasopressor -others Secondary end points : data collection from spinal anesthesia induction until weaning of vasopressor

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Countries

France

Contacts

Public ContactBELIN Olivier

CHR d'ORLEANS

olivier.belin@chr-orleans.fr33238514444

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026