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NCT Number: NCT02962986

A Comparison of Intermittent Intravenous Boluses of Phenylephrine and Norepinephrine to Prevent Spinal-induced Hypotension in Cesarean Deliveries

Hypotension is a very common complication of spinal anesthesia for cesarean delivery, and can have unwanted side effects on both mother and fetus if not treated promptly. Phenylephrine has been the drug of choice to treat this spinal-induced hypotension. Although phenylephrine is safe to use for this indication, it has been associated with reflex bradycardia and a reduction in cardiac output.

Norepinephrine is a potent vasopressor used to treat hypotension in the critical care setting. Recent studies have looked at norepinephrine's use in the obstetric setting, and have shown that it can be used safely and also has favourable hemodynamic properties when compared to phenylephrine, with less bradycardia and less depression of cardiac output.

The investigators recently conducted a study to determine the ED90 of norepinephrine, and now plan to compare bolus doses of phenylephrine to norepinephrine for treating hypotension following spinal anesthesia for cesarean section.

The investigators hypothesize that norepinephrine, when given as a bolus to prevent post spinal hypotension, will result in around 70% relative decrease in the rate of bradycardia when compared to phenylephrine in patients undergoing elective cesarean delivery under spinal anesthesia.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

About this study

Norepinephrine is a potent vasopressor used to treat hypotension in the critical care setting. Recent studies have looked at norepinephrine's use in the obstetric setting, and have shown that it can be used safely and also has favourable hemodynamic properties when compared to phenylephrine, with less bradycardia and less depression of cardiac output. These studies have been limited to using norepinephrine as an infusion and there is limited data with it being used as a bolus to prevent hypotension. A recent study was undertaken at Mount Sinai hospital to determine the ED90 of norepinephrine to treat post spinal hypotension. Secondary outcome data from this trial showed that the incidence of bradycardia associated with this treatment is approximately 7.5%, several times less when compared to the reported 30% with phenylephrine. It would therefore be prudent at this stage to undertake a randomized trial comparing the hemodynamic profile of phenylephrine (our standard practice) and norepinephrine used as intermittent boluses to prevent hypotension and avoid decrease in heart rate during cesarean delivery.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Informed consent
  • Elective CS under spinal anesthesia
  • Normal singleton pregnancy beyond 36 weeks gestation
  • ASA physical status 2-3
  • Current (pregnant) weight 50-100 kg, height 150-180 cm
  • Age over 18 years

Exclusion criteria

  • Patient refusal
  • Inability to communicate in English
  • Allergy or hypersensitivity to phenylephrine
  • Preexisting or pregnancy-induced hypertension
  • Cardiovascular or cerebrovascular disease
  • Fetal abnormalities
  • History of diabetes, excluding gestational diabetes
  • Contra-indications for spinal anesthesia
  • Allergy or hypersensitivity to sulfite
  • Use of monoamine oxidase inhibitors, triptyline or imipramine antidepressants
  • Untreated hyperthyroid patients

Treatment and study plan

norepinephrine

Drug

Norepinephrine diluted in 5% dextrose solution to a concentration of 6mcg/mL

Other names: Norepinephrine bitartrate

Phenylephrine

Drug

Phenylephrine diluted in 0.9% normal saline solution to a concentration of 100mcg/mL

Other names: Phenylephrine Hydrochloride

Primary outcomes

  1. Bradycardia: Heart rate less than 50 bpm

    Time frame: 30 minutes

    Heart rate less than 50 bpm, from induction of spinal anesthesia

Secondary outcomes

  1. Hypotension: Systolic blood pressure less than 80% of baseline

    Time frame: 30 minutes

    Systolic blood pressure below 80% of baseline, from induction of spinal anesthesia to delivery of the fetus.

  2. Number of hypotensive episodes

    Time frame: 30 minutes

    The number of times the systolic blood pressure measures below 80% of baseline, from induction of spinal anesthesia to delivery of the fetus.

  3. Hypertension: Systolic blood pressure at or above 120% of baseline

    Time frame: 30 minutes

    Systolic blood pressure at or above 120% of baseline, from induction of spinal anesthesia to delivery of the fetus.

  4. Tachycardia: Heart rate greater than 30% of baseline

    Time frame: 30 minutes

    Heart rate greater than 30%, from induction of spinal anesthesia to delivery of the fetus.

  5. Presence of nausea

    Time frame: 30 minutes

    Presence of nausea in patients from induction of spinal anesthesia to delivery of the fetus.

  6. Number of episodes of nausea

    Time frame: 30 minutes

    The number of episodes of nausea experienced by patients from induction of spinal anesthesia to delivery of the fetus.

  7. Presence of vomiting

    Time frame: 30 minutes

    Presence of vomiting in patients from induction of spinal anesthesia to delivery of the fetus.

  8. Number of episodes of vomiting

    Time frame: 30 minutes

    The number of episodes of vomiting experienced by patients from induction of spinal anesthesia to delivery of the fetus.

  9. Total dose of study drug given

    Time frame: 30 minutes

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

  10. Apgar scores

    Time frame: 1 minute and 5 minutes

    The Apgar scores of the infant at 1 and 5 minutes post delivery.

  11. Umbilical artery pH

    Time frame: 24 hours

    Umbilical artery pH

  12. Umbilical artery partial pressure of carbon dioxide

    Time frame: 24 hours

    Umbilical artery partial pressure of carbon dioxide

  13. Umbilical artery partial pressure of oxygen

    Time frame: 24 hours

    Umbilical artery partial pressure of oxygen

  14. Umbilical artery bicarbonate (mmol/L)

    Time frame: 24 hours

    Umbilical artery bicarbonate

  15. Umbilical artery base excess (mmol/L)

    Time frame: 24 hours

    Umbilical artery base excess

  16. Umbilical vein pH

    Time frame: 24 hours

    Umbilical vein pH

  17. Umbilical vein partial pressure of carbon dioxide

    Time frame: 24 hours

    Umbilical vein partial pressure of carbon dioxide

  18. Umbilical vein partial pressure of oxygen

    Time frame: 24 hours

    Umbilical vein partial pressure of oxygen

  19. Umbilical vein bicarbonate (mmol/L)

    Time frame: 24 hours

    Umbilical vein bicarbonate

  20. Umbilical vein base excess (mmol/L)

    Time frame: 24 hours

    Umbilical vein base excess

Sponsors and collaborators

Lead sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Other

Registry information

Official study title

A Comparison of Intermittent Intravenous Boluses of Phenylephrine and Norepinephrine to Prevent Spinal-induced Hypotension in Cesarean Deliveries: a Randomized Controlled Study

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Nov 15, 2016
Registry last updated
May 24, 2017

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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