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Completed

NCT Number: NCT03849508

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

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.

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Key information

Conditions

Cesarean Section Complications Spinal Anesthesia

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Regional Hospital Center of ORLEANS

Orléans, 45067, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

norepinephrine

Drug

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

Phenylephrine

Drug

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

Primary outcomes

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

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

    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.

Secondary outcomes

  1. Heart rate

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

    number of heart beats per minute

  2. Systolic blood pressure

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

    Systolic blood pressure measured in mmHg

  3. Mean blood pressure

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

    Mean blood pressure measured in mmHg

  4. Duration of bradycardia

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

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

  5. Duration of hypotension with Mean blood pressure less than 65mmHg

    Time frame: after applying spinal anesthesia until weaning of vasopressor

    Cumulative time in minutes

  6. Duration of hypotension with Systolic Blood Pressure less than 80mmHg

    Time frame: after applying spinal anesthesia until weaning of vasopressor

    Cumulative time in minutes

  7. Duration of hypertension

    Time frame: after applying spinal anesthesia until weaning of vasopressor

    Cumulative time in minutes with Systolic Blood Pressure more than 140mmHg

  8. Cardiac Output

    Time frame: after applying spinal anesthesia until weaning of vasopressor

    Measured in L/min

  9. Stroke Volume

    Time frame: after applying spinal anesthesia until weaning of vasopressor

    Measured in ml/beat

  10. Total Peripheral Resistance

    Time frame: after applying spinal anesthesia until weaning of vasopressor

    Measured in dynes.sec.cm-5

  11. Maximum flow rate of study drug given

    Time frame: after applying spinal anesthesia until weaning of vasopressor

    Measured in mcg/hour

  12. Total dose of study drug consumed

    Time frame: after applying spinal anesthesia until weaning of vasopressor

    Total dose of study drug given from induction of spinal anesthesia to delivery of the fetus

  13. Total Rescue Bolus Dose of atropine to maintain Systolic Blood Pressure

    Time frame: after applying spinal anesthesia until weaning of vasopressor

    Total dose of atropine administered (mg)

  14. Total Rescue Bolus Dose of ephedrine or other vasopressor to maintain Systolic Blood Pressure

    Time frame: after applying spinal anesthesia until weaning of vasopressor

    Total dose of ephedrine or other vasopressor administered (mg)

  15. Incidence of nausea or vomiting

    Time frame: after applying spinal anesthesia until weaning of vasopressor

    The percentage of patients with nausea or vomiting (at least one episode)

  16. Incidence of dizziness or malaise

    Time frame: after applying spinal anesthesia until weaning of vasopressor

    The percentage of patients with dizziness or malaise (at least one episode)

  17. Maternal blood glucose concentration

    Time frame: at peripheral intravenous line placement

    concentration measured in mmol/l

  18. Maternal blood glucose concentration

    Time frame: at umbilical cord clamping

    concentration measured in mmol/l

  19. APGAR score

    Time frame: 1 minute after delivery

    APGAR score of the fetus ranging from 0 to 10

  20. APGAR score

    Time frame: 3 minutes after delivery

    APGAR score of the fetus ranging from 0 to 10

  21. APGAR score

    Time frame: 5 minutes after delivery

    APGAR score of the fetus ranging from 0 to 10

  22. APGAR score

    Time frame: 10 minutes after delivery

    APGAR score of the fetus ranging from 0 to 10

  23. Umbilical arterial potential hydrogen

    Time frame: At time of birth

    potential hydrogen in the blood sample obtained from umbilical artery scaled from 1 to 14

  24. Fetal lactates

    Time frame: At time of birth

    from umbilical artery blood sample, measured in mmol/l

  25. Umbilical arterial partial pressure of carbon dioxide

    Time frame: At time of birth

    in the blood sample obtained from umbilical artery measured in mmHg

  26. Umbilical arterial partial pressure of oxygen

    Time frame: At time of birth

    in the blood sample obtained from umbilical artery measured in mmHg

  27. Umbilical arterial base excess

    Time frame: At time of birth

    in the blood sample obtained from umbilical artery measured in mmol/L

  28. Fetal blood glucose concentration at birth

    Time frame: At time of birth

    from umbilical artery blood sample, measured in mmol/l

  29. Neonatal blood glucose concentration

    Time frame: at 1 hour after birth

    Capillary blood glucose is measured in mmol/l

  30. Uterine and umbilical arteries Doppler with measurement of the pulsatility

    Time frame: 5 minutes before realization of spinal anesthesia

    pulsatility index of Gosling (peak systolic velocity - end diastolic velocity /mean velocity)

  31. Uterine and umbilical arteries Doppler with measurement of the pulsatility

    Time frame: 5 minutes after induction of spinal anesthesia

    pulsatility index of Gosling (peak systolic velocity - end diastolic velocity /mean velocity)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional d'Orléans

Other

Registry information

Official study title

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

Acronym: PHENAD

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 21, 2019
Registry last updated
May 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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