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Completed

NCT Number: NCT04556370

Norepinephrine Prophylaxis for Postspinal Anesthesia Hypotension in Parturients With Preeclampsia.

The purpose of this study is to investigate the suitable infusion dose of norepinephrine for prophylaxis against postspinal anesthesia hypotension in parturients with preeclampsia undergoing cesarean section.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 75004, China

About this study

Preeclampsia, which affects 5% to 7% of parturients, is a significant cause of maternal and neonatal morbidity and mortality. Because of constricted myometrial spiral arteries with exaggerated vasomotor responsiveness, though blood pressure in parturients with preeclampsia are apparently higher than healthy parturients, placental hypoperfusion is more common. Spinal anesthesia is still the preferred mode of anesthesia in parturients with preeclampsia for cesarean section. In preeclampsia parturients, spinal anesthesia improve intervillous blood flow (provided that hypotension is avoided) which contribute to increase placental perfusion. Even so, 17-26% parturients with preeclampsia experienced postspinal anesthesia hypotension due to the extensive sympathetic block that occurred with spinal anesthesia. As a potential substitute drug for phenylephrine and ephedrine, norepinephrine has gained traction for use in parturients undergoing cesarean section. But the suitable infusion dose of norepinephrine in parturients with preeclampsia is still unknown. The purpose of this study is to investigate the suitable infusion dose of norepinephrine for prophylaxis against post-spinal anesthesia hypotension in parturients with preeclampsia undergoing cesarean section.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18-45 years
  • Primipara or multipara
  • Singleton pregnancy ≥32 weeks
  • American Society of Anesthesiologists physical status classification II to III
  • Scheduled for cesarean section under spinal anesthesia

Exclusion criteria

  • Baseline blood pressure ≥180 mmHg
  • Body height < 150 cm
  • Body weight > 100 kg or body mass index (BMI) ≥ 40 kg/m2
  • Eclampsia or chronic hypertension
  • Hemoglobin < 7g/dl
  • Fetal distress, or known fetal developmental anomaly

Treatment and study plan

normal saline

Drug

Normal saline infusion simultaneous with subarachnoid block

Other names: NS

norepinephrine

Drug

Different infusion dose of norepinephrine simultaneous with subarachnoid block

Other names: Vasopressors

Primary outcomes

  1. The incidence of post-spinal anesthesia hypotension

    Time frame: 1-15 minutes after spinal anesthesia.

    Systolic blood pressure (SBP) < 80% of the baseline

Secondary outcomes

  1. Overall stability of systolic blood pressure control versus baseline

    Time frame: 1-15 minutes after spinal anesthesia

    Evaluated by performance error (PE)

  2. Overall stability of heart rate control versus baseline

    Time frame: 1-15 minutes after spinal anesthesia

    Evaluated by performance error (PE)

  3. The incidence of severe post-spinal anesthesia hypotension

    Time frame: 1-15 minutes after spinal anesthesia

    Systolic blood pressure (SBP) < 60% of the baseline

  4. The incidence of nausea and vomiting

    Time frame: 1-15 minutes after spinal anesthesia

    Presence of nausea and vomiting in patients after spinal anesthesia

  5. The incidence of bradycardia

    Time frame: 1-15 minutes after spinal anesthesia

    Heart rate < 55 beats/min

  6. The incidence of hypertension.

    Time frame: 1-15 minutes after spinal anesthesia

    Systolic blood pressure (SBP) >120% of the baseline.

  7. pH

    Time frame: Immediately after delivery

    From umbilical arterial blood gases.

  8. Partial pressure of oxygen

    Time frame: Immediately after delivery

    From umbilical arterial blood gases.

  9. Base excess

    Time frame: Immediately after delivery

    From umbilical arterial blood gases.

  10. APGAR score

    Time frame: 1 min after delivery

    A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration

  11. APGAR score

    Time frame: 5 min after delivery

    A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration

Sponsors and collaborators

Lead sponsor

General Hospital of Ningxia Medical University

Other

Registry information

Official study title

Norepinephrine Prophylaxis for Postspinal Anesthesia Hypotension in Parturients With Preeclampsia Undergoing Cesarean Section: a Randomized, Placebo-controlled Dose-finding Trial

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 21, 2020
Registry last updated
Jun 13, 2023

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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